天津职业大学 文本 A Randomized Clinical Trial of Vision TherapyOrthoptics versus Pencil Pushups for theTreatment of Convergence Insufficiency inYoung Adults_眼屈光学

3a5mBe0L-品0.T,形Few5 DFTONETI ANDVIKINENCE ORIGINAL ARTICLE A Randomized Clinical Trial of Vision Therapy/ Orthoptics versus Pencil Pushups for the Treatment of Convergence Insufficiency in Young Adults MITCHELL SCHEIMAN,OD,FAAO,G.LYNN MITCHELL,MAS,FAAO, SUSAN COTTER,OD,FAAO,MARJEAN TAYLOR KULP,OD,MS,FAAO, JEFFREY COOPER,OD,MS,FAAO,MICHAEL ROUSE,OD,MS,FAAO, ERIC BORSTING,OD,MS,FAAO,RICHARD LONDON,MS,OD,FAAO,and JANICE WENSVEEN,OD,PhD,FAAO Fre Jusrinte,PenNsaania College of Optowerry.Pbildelpois.Pennsplponi [M5):Opromerry Coordinating Center (GLM and School of Opiomeiry (T.The Obio Siate Univemiy,Coltau,Oio:Soubern Calforui College ofOptomeiry Fero Califori (SC. MR.EB:Callege ofOptome.State Liaieraity of New Yark.New Yark.Nea York UCl:College ofOpiometry.Pacifie Unersity. Partitnd Orrgon (RI and CollegOptowetry.Uainerity f Hounan.Houuon.Teca W) ABSTRACT:Purpase.The purpose of this article is to compare vision therapy/orthoptics,pencil pushups,and placeho vision therapy/orthoptics as treatments for symptomatic comvergence insufficiency in adults 19 to 30 years of age. Methods.In a randomized,multicenter clinical trial,46 adults 19 to 30 years of age with symptomatic convergence insufficiency were randomly assigned to receive 12 weeks of office-based vision therapy/orthoptics,office-based placebo vision therapy/orthoptics,or home-based pencil pushups.The primary outcome measure was the symptom score on the Convergence Insufficiency Symptom Survey.Secondary outcome measures were the near point of convergence and positive fusional vergence at near.Results.Only patients in the vision therapy/orthoptics group demonstrated statistically and clinically significant changes in the near point of comvergence (12.8 cm to 5.3 cm,p= 0.002)and positive fusional vergence at near (11.3A to 29.7A,p =0.001).Patients in all three treatment arms demonstrated statistically significant improvement in symptoms with 42%in office-based vision therapy/orthoptics, 31%in office-based placebo vision therapy/orthoptics,and 20%in home-based pencil pushups achieving a score <21 (our predetermined criteria for elimination of symptoms)at the 12-week visit.Discussion.In this study,vision therapy/orthoptics was the only treatment that produced clinically significant improvements in the near point of convergence and positive fusional vergence.However,over half of the patients in this group (58%)were still symptomatic at the end of treatment,although their symptoms were significantly reduced.All three groups demon. strated statistically significant changes in symploms with 42%in office-based vision therapy/orthoptics,31%in office-based placebo vision therapy/orthoptics,and 20%in home-based pencil push-ups meeting our criteria for elimination of symptoms.(Optom Vis Sci 2005;82:E583-E595) Key Words:comvergence insufficiency,visian therapy,arthoptics,pencil push-ups,placebo,exophoria,eyestrain. syinploms here isa lack of comsensus regarding the most appropriate tics Recentudies surveying the ophthalmic community to treatment for convergence insuffixciency (Cl)in young decermine the most widespread treament modaliry for patients adults.Various treatments are prosibed,induding bas-in with symptomaticCl bave found that percil pushups is the mo prism glsses,home-hased pencil push-ups.home-based vision commonly prescribed treatment by hoth ophthalmologists and therapyiorthopties,and afficr-based vision therapylonhop- optometrists far young ad Despite the apparent clinical Optomebry and Viuiau Srimer,Val K2.Na.Jely25 Copyright American Academy of Optometry.Unauthonzed reproducton of this art cle is prohibited

ORIGINAL ARTICLE A Randomized Clinical Trial of Vision Therapy/ Orthoptics versus Pencil Pushups for the Treatment of Convergence Insufficiency in Young Adults MITCHELL SCHEIMAN, OD, FAAO, G. LYNN MITCHELL, MAS, FAAO, SUSAN COTTER, OD, FAAO, MARJEAN TAYLOR KULP, OD, MS, FAAO, JEFFREY COOPER, OD, MS, FAAO, MICHAEL ROUSE, OD, MS, FAAO, ERIC BORSTING, OD, MS, FAAO, RICHARD LONDON, MS, OD, FAAO, and JANICE WENSVEEN, OD, PhD, FAAO Eye Institute, Pennsylvania College of Optometry, Philadelphia, Pennsylvania (MS); Optometry Coordinating Center (GLM) and School of Optometry (MTK), The Ohio State University, Columbus, Ohio; Southern California College of Optometry, Fullerton, California (SC, MR, EB); College of Optometry, State University of New York, New York, New York (JC); College of Optometry, Pacific University, Portland, Oregon (RL); and College of Optometry, University of Houston, Houston, Texas (JW) ABSTRACT: Purpose. The purpose of this article is to compare vision therapy/orthoptics, pencil pushups, and placebo vision therapy/orthoptics as treatments for symptomatic convergence insufficiency in adults 19 to 30 years of age. Methods. In a randomized, multicenter clinical trial, 46 adults 19 to 30 years of age with symptomatic convergence insufficiency were randomly assigned to receive 12 weeks of office-based vision therapy/orthoptics, office-based placebo vision therapy/orthoptics, or home-based pencil pushups. The primary outcome measure was the symptom score on the Convergence Insufficiency Symptom Survey. Secondary outcome measures were the near point of convergence and positive fusional vergence at near. Results. Only patients in the vision therapy/orthoptics group demonstrated statistically and clinically significant changes in the near point of convergence (12.8 cm to 5.3 cm, p
0.002) and positive fusional vergence at near (11.3 to 29.7, p
0.001). Patients in all three treatment arms demonstrated statistically significant improvement in symptoms with 42% in office-based vision therapy/orthoptics, 31% in office-based placebo vision therapy/orthoptics, and 20% in home-based pencil pushups achieving a score <21 (our predetermined criteria for elimination of symptoms) at the 12-week visit. Discussion. In this study, vision therapy/orthoptics was the only treatment that produced clinically significant improvements in the near point of convergence and positive fusional vergence. However, over half of the patients in this group (58%) were still symptomatic at the end of treatment, although their symptoms were significantly reduced. All three groups demon￾strated statistically significant changes in symptoms with 42% in office-based vision therapy/orthoptics, 31% in office-based placebo vision therapy/orthoptics, and 20% in home-based pencil push-ups meeting our criteria for elimination of symptoms. (Optom Vis Sci 2005;82:E583–E595) Key Words: convergence insufficiency, vision therapy, orthoptics, pencil push-ups, placebo, exophoria, eyestrain, symptoms There is a lack of consensus regarding the most appropriate treatment for convergence insufficiency (CI) in young adults. Various treatments are prescribed, including base-in prism glasses, home-based pencil push-ups, home-based vision therapy/orthoptics, and office-based vision therapy/orthop￾tics.1–11 Recent studies surveying the ophthalmic community to determine the most widespread treatment modality for patients with symptomatic CI have found that pencil pushups is the most commonly prescribed treatment by both ophthalmologists and optometrists for young adults.12,13 Despite the apparent clinical 1040-5488/05/8207-0583/0 VOL. 82, NO. 7, PP. E583–E595 OPTOMETRY AND VISION SCIENCE Copyright © 2005 American Academy of Optometry Optometry and Vision Science, Vol. 82, No. 7, July 2005

E584 Convergence Insufficicncy in Young Adults Scheiman ct al. popularity of pencil pachups foe Cl,there has been onh a single ment Trial Gmoup six dinical sitesa shoals and collegss of pancontrollod study of 25 paticnt that has cvaluated the cffoctive- optometry in Callifornia,New York,Ohio,Ongon,Pennspvania, ess of this treament modality.Of the 25 paticnts with Cl who and Texas(sAppendix 1).The ah followed the tenets ofthe underwent treatment with pencil pusbups,oly seven (28%)of Decaration of Helsinki,and informed consent ws obained from them had improved signs and sympcoms the patients after explanation of the nature and possible conse Of the various trearments commonly recommended for CI. quences of the study.The protocol and infomed oonsent forms only officc-hasd vision therapylorthoptics has ben extiniy were approved by cach Imstitutional Revicw Buard. evaluatod.Grisham reviewed the ophthalmic literature relative to reatet resalfor CI using vision therapy or orthopcics for the years 1940 to 1987 and summarized 17 studies with a toral of 1931 Patient Selection patients.He calculated a weighted cure rate of 72%.n improved Eligibiliry testing,induded administration of the original 13. rate of 19%6,and a 9%failure rate.All of the studies revicwed. item version of the CI Symptom Survey (CISS-V13 described bowever,had one or more of the following design flaws:lack of a subsequently)to identify wbether a patient with Cl was symptom- ckear definition of CI.inadequare definition of successful outcome. atic.At the time of eligibility testing,the revised Cl Sympom retraspective design,failure to use masked examiners for ourcome Survey with 15 items (CISS V15)had not yet been validared. measures,small sample sixe,or no control group.Although two of Therefore,the 13-item version wis used only for eligibaliry testing. the studies were propective,double-blind,placebo-controlld and subsoqucntly the 15-item verion(Appendix 1)was ud to studies showing that vergence therapy increased positive fusional assess symptoms at the first trearment visit and changes during vergence and decreased sympcoms in patients with Cl,thesesud trearment,and served as the primary outcome meagare. ies had smalsapleInaree rdomid,ood Other eligibiliry testing included best corrected visual acuiry ar srudy ofG0 adult pariencs with CI.Birnbuum and colleagues found disrance and pear.cydoplegic refraction,and a sensoimotor that office-based vision therapy was successful in 61.9%of pa- examination that included cover testing at distance and near,near tients whereas bome-bised vision therapy was sucesul in only point of comvergence,positive and negative fuional vergence at 10.5%of parients.However,the study did not have a placebo near,near stereoacuity.monccular accommodative amplitude control group and the investigators did not use msked examiners and monocular accommodative faciliry.All testing was performed to gacher ourcome data. using standardized procoools and had to be performed no more Thus,there is both a lack of comsensus regarding the most ap- than 2 moeths before randomization.The mean time fromn eligi- propriate treatment for CI in young adults and lack of qualiry bility testing,to randomication was 3.3 days (standard deviation scientific data abour the various treatments.Inarecently publisbed [SD]6.2)with a maximum lg in randomization of 30 days. study,we repored the resules of a randomied clinical trial of Fifty-two percent (24 of of the patients were randomizedo vision therapyfonhoptics versus pencil pushups for CI in cha the day of eligibiliry testing. dren.a Vision therapy/orthoptics was found to be more effective The near point of convergence was measured with the Astroe than pencil pushups or placebo vision therapy/orthoptics in reduc International (ACR/21)Accommodative Rule.The device consiss ing ymptoes and improwing sgns ofCI in children 9 o 18 years of ofa rod with a mowable,single column of letters (20/30 equivalent eNecher pencil puhups not placebo vision therapw/orthopeics was at 10 cm).Instructions were similar to the ones described by I layes effective in improwing eher sympcoms ce signs associted with CI et aThree near point of convergence measuremens were oh- The sudy repored here wis conducd simulaneoy with young tained,and the average value was ed o determine dighiliry and adult pertients (s 19-30 years)using the identical prontoodl. later to s the teatment effeat.Positive fidonal vrgenee (blut, The Comvergence Inufficiency Trearment Trial (CITT study break.and reoovery)was measured with a horiontal prism bar group designed this pilot study in preparation foe a langer random (Gulden B-15 hotizceral prism bar-1A to 45A)while the patient ized clinical trial.This study was a masked,plccho-controlled. viewed a 20/30 sise column of letters (Gulden Fixation Stick no. muleicenter.randomized dinical trial in which young adults 19 to 15,302)held at 40 em.Positive fusional vergrnce was measured 30 years of age were randomly assignod to onc of three treatmente three times with ar leat 30 soconds herwern cach measure:the pencil pushups,office-based vision therapyorthoptics (vision mean of the three measures was used to determine eligibility. therapyiorthoptics).oe office-based plcebo vison therapyfor- Ifa parient wis wearing glasses and no change in prescription was thoptics (placebo vision therapyfarthoptics)The purpase of this necexsiry.randomization occurred immedutely.Ifa significant refrac- study was ta determine if,after 12 wreks of treatment.cither or tive crot was peesent or a ignificant chings in refracrive crrecticn both of rwo popular treamens forC(penel pushups and vision wasroind,new ghsss ware proscrihod.A significamt refractive crur therapylorthoptics)was moce effective than placebo tearment. or change in needed vefiacrive conection was defineds1.50D and ifso,whether one treatment was more effective than the ocher hyperopia,2050D myopia,=0 D asrigmatism.20.75 D anso- in improving symptoms and signs ased with symptomanc CI metropi in spherical equivalent,ee 21.50 D anmometropia in any in young adultx. mrridian (hased cn cydoplrgic mefraction).Afier wraring the gses far at mimimum of 2 wocks cligbiity tosting was rpeatad to dtr- PATIENTS AND METHODS mine if the patient stil met the cigibility criteria. Mor eligibility criteri for the tial incuded dules a19to This study,supportnd hy the Natioel Eye Institute of the Na- 30 years inclusive,exnpheria at near a least 4A greater than at far. tionl Instirutes of Health,Department of Health and Humin a receded near point of comengence beeak of 6 em oe greater,and Serico,was cunductod by the Comvergence Insufficicncy Treat- insufficient positive fusionl comergenoc at near (i.c.failing 0 camnbry and2 au Srimen,Yol2,k不，t5 Copyright American Academy of Optometry.Unauthonzed reproduction of this artcle is prohibited

popularity of pencil pushups for CI, there has been only a single noncontrolled study of 25 patients that has evaluated the effective￾ness of this treatment modality.11 Of the 25 patients with CI who underwent treatment with pencil pushups, only seven (28%) of them had improved signs and symptoms. Of the various treatments commonly recommended for CI, only office-based vision therapy/orthoptics has been extensively evaluated. Grisham14 reviewed the ophthalmic literature relative to treatment results for CI using vision therapy or orthoptics for the years 1940 to 1987 and summarized 17 studies with a total of 1931 patients. He calculated a weighted cure rate of 72%, an improved rate of 19%, and a 9% failure rate. All of the studies reviewed, however, had one or more of the following design flaws: lack of a clear definition of CI, inadequate definition of successful outcome, retrospective design, failure to use masked examiners for outcome measures, small sample size, or no control group. Although two of the studies were prospective, double-blind, placebo-controlled studies showing that vergence therapy increased positive fusional vergence and decreased symptoms in patients with CI, these stud￾ies had small sample sizes.15,16 In a recent randomized, controlled study of 60 adult patients with CI, Birnbaum and colleagues found that office-based vision therapy was successful in 61.9% of pa￾tients, whereas home-based vision therapy was successful in only 10.5% of patients.17 However, the study did not have a placebo control group and the investigators did not use masked examiners to gather outcome data. Thus, there is both a lack of consensus regarding the most ap￾propriate treatment for CI in young adults and lack of quality scientific data about the various treatments. In a recently published study, we reported the results of a randomized clinical trial of vision therapy/orthoptics versus pencil pushups for CI in chil￾dren.18 Vision therapy/orthoptics was found to be more effective than pencil pushups or placebo vision therapy/orthoptics in reduc￾ing symptoms and improving signs of CI in children 9 to 18 years of age. Neither pencil pushups nor placebo vision therapy/orthoptics was effective in improving either symptoms or signs associated with CI. The study reported here was conducted simultaneously with young adult patients (ages 19 –30 years) using the identical protocol. The Convergence Insufficiency Treatment Trial (CITT) study group designed this pilot study in preparation for a larger random￾ized clinical trial. This study was a masked, placebo-controlled, multicenter, randomized clinical trial in which young adults 19 to 30 years of age were randomly assigned to one of three treatments: pencil pushups, office-based vision therapy/orthoptics (vision therapy/orthoptics), or office-based placebo vision therapy/or￾thoptics (placebo vision therapy/orthoptics). The purpose of this study was to determine if, after 12 weeks of treatment, either or both of two popular treatments for CI (pencil pushups and vision therapy/orthoptics) was more effective than placebo treatment, and if so, whether one treatment was more effective than the other in improving symptoms and signs associated with symptomatic CI in young adults. PATIENTS AND METHODS This study, supported by the National Eye Institute of the Na￾tional Institutes of Health, Department of Health and Human Services, was conducted by the Convergence Insufficiency Treat￾ment Trial Group at six clinical sites at schools and colleges of optometry in California, New York, Ohio, Oregon, Pennsylvania, and Texas (see Appendix 1). The research followed the tenets of the Declaration of Helsinki, and informed consent was obtained from the patients after explanation of the nature and possible conse￾quences of the study. The protocol and informed consent forms were approved by each Institutional Review Board. Patient Selection Eligibility testing included administration of the original 13- item version of the CI Symptom Survey (CISS-V13 described subsequently) to identify whether a patient with CI was symptom￾atic. At the time of eligibility testing, the revised CI Symptom Survey with 15 items (CISS-V15) had not yet been validated. Therefore, the 13-item version was used only for eligibility testing, and subsequently the 15-item version19 (Appendix 1) was used to assess symptoms at the first treatment visit and changes during treatment, and served as the primary outcome measure. Other eligibility testing included best-corrected visual acuity at distance and near, a cycloplegic refraction, and a sensorimotor examination that included cover testing at distance and near, near point of convergence, positive and negative fusional vergence at near, near stereoacuity, monocular accommodative amplitude, and monocular accommodative facility. All testing was performed using standardized protocols and had to be performed no more than 2 months before randomization. The mean time from eligi￾bility testing to randomization was 3.3 days (standard deviation [SD]
6.2) with a maximum lag in randomization of 30 days. Fifty-two percent (24 of 46) of the patients were randomized on the day of eligibility testing. The near point of convergence was measured with the Astron International (ACR/21) Accommodative Rule. The device consists of a rod with a movable, single column of letters (20/30 equivalent at 40 cm). Instructions were similar to the ones described by Hayes et al.20 Three near point of convergence measurements were ob￾tained, and the average value was used to determine eligibility and later to assess the treatment effect. Positive fusional vergence (blur, break, and recovery) was measured with a horizontal prism bar (Gulden B-15 horizontal prism bar—1‚ to 45‚) while the patient viewed a 20/30 size column of letters (Gulden Fixation Stick no. 15,302) held at 40 cm. Positive fusional vergence was measured three times with at least 30 seconds between each measure; the mean of the three measures was used to determine eligibility. If a patient was wearing glasses and no change in prescription was necessary, randomization occurred immediately. If a significant refrac￾tive error was present or a significant change in refractive correction was required, new glasses were prescribed. A significant refractive error or change in needed refractive correction was defined as
1.50 D hyperopia,
0.50 D myopia,
0.75 D astigmatism,
0.75 D aniso￾metropia in spherical equivalent, or
1.50 D anisometropia in any meridian (based on cycloplegic refraction). After wearing the glasses for at minimum of 2 weeks, eligibility testing was repeated to deter￾mine if the patient still met the eligibility criteria. Major eligibility criteria for the trial included adults ages 19 to 30 years inclusive, exophoria at near at least 4‚ greater than at far, a receded near point of convergence break of 6 cm or greater, and insufficient positive fusional convergence at near (i.e., failing E584 Convergence Insufficiency in Young Adults—Scheiman et al. Optometry and Vision Science, Vol. 82, No. 7, July 2005

Convorgence Insufiiciency in Young Adults-Scheiman ot al.E585 Shcard's criteriun (positive fusional vergence less than twice the Pencil Pushups pear phoriaor minimum positive fusional vergence of 15 bascout break),and a score of 9 on the CISS-V13.Table 1 provides a Patients in the pencil phups group wer taught a pencil pushup complece Esing of the eligibility and exdusion criteria procedure that included monitoring for suppresion The pacicnt was instructed to hold a pencil at arm's kngth diroctly between his or her eyes and an index card,which served as a suppression oontrol,was Treatment Protocols phood on thewall6o8长tmy,The paticn时sinructdlook at The Ohio State University Optometry Coordinating Center, the tipofthesharpendpencil and ttryto kep the pencil point singk the data coordinating center for the study,randomly issigned eli while moving it tuward his or her nuse.If one of the cards in the gibk parients with ou probability to pencil pushups,vision ther- background disppeared,the patient was td to stop moving apyforthoptics,and phocbo vision therapy/orthuptics tatmnt the pencil and blink his or her eyes uncil both cds were present.The arms.Randomization was accomplished on the study's web site paticnt was tokl to cuntinue moving the pencil skwly toward his or using blocks of six so the investigator could not predict the se her noo untiitoould no longer be kept single and then to try tongain quence of treatment assignments.To ensure approximately equa sirgle vision.If the patient was able to regain single vision,he or sbe mumbers of paticnts in cach tatment arm at any given clinical wisked to continue moving the perxcil doser to hisor her nose.If the center,randomication was performed stparanely for each sice. parient could not regain single viion,he or she was instructed to start the procodune again.Patients ware instnctod to do thnoe scts of 20 pushups per dy at home,5 days per wock for 12 wodks,and this TABLE 1. treamet required aproximatdy 15 minutes per day.Befoce per Eligibility and exclusion criteria forming the pcocedure ar home,the patient had to demonstrate in the Bligibility criteria office that he or she understood and had the abiliry to perform the Age 19-30 years inclusive procedurecdo the prooocl. Best-comected visual acuity of 2025 in hoth eyes at distance and near Office-Based Vision Therapy/Orthoptics Willingness to wear eyeglasses or contact lenees to comect refraclive emor.necessary (VT/Orthoptics) Exuphoria al near at least 4 greater than al far The vision therapyforthoptics group rd therapy adminis Insufficient postrve fusonal comvergence ILe,failing tered by a trained therapist during a weekly,60-minute oftice visit Sheard's cntoron21 or less than 15 breakl with additional procedures to be performed at home for 15 min Repeded near point of convergence of gresater than or equal utes a day,five times per week for 12 weeks.The office and to 6 cm break Appreciation of at least 500 seconds of arc on the forms part homc-baod prooodures uscd are described in detail clsewhene and of the Randat Socreatest are fisted in Table 2 alng with a short decription of cach proce- aSymptom Survey-V13 original 13-item versian)score 9 dure.The items listed in 'Table 2 are the specific prooodures per- Inlormed consent and willingness to participate in the stuy formed by each patient in this treatment arm during the weekly and he randomizod office based vision therapylorthoptics sessions.In addition,treat ment proocdures were practicd at home.During a typical office- Exclusion citeria based treatment session,the patient practiced four to five proce- Cl previously trealed with pencil pushups or affice-based dures with cot supervision and guidance from the therapist. vision therapworthoptics ino more than 2 monchs of There were po diagnosti:tests performed during these sessions. trearment within the past year) Amblyopia The therapist followed a very detailed and specific protocol from the CTTT Manal of Procedures,which described the peoper treat- Constant strab、mius History of strabismus surgery ment technique,amount of time the technique was to be done, Anisamctropia 1.50 D dfference botwcen cyes expected performance,and the criteria required to advance to a Pnoe refractive surgcry more difficult level or to the next procedure in the treatment se Vertical heterophoria greater than I Systemic diseases known to affoct accommodatian,verponce, TABLE 2. and ocular motility such as multiple sclemsis,Graves' thyroid discase.myasthenia gravis,diabetes,and Parkinson Office based vision therapy/orthoptics procedures discase Loose lens accommodative facility Ary ccular or systemic medication known to affect Letter chart accommodative facility accommodation or vergcnce Binccular accommadative facility Monocular accommodative amplitude less than 4D in cither Brock string eye as mesured by the pushup method Bimdl card Manifest or latent nyslagmus Veciograms Housohold membor almady enrolled in the CITT Computer orthoplics (random dot slereogram procedurel Amy eye care professional,ophchalmic technician,medical Aperture rule trainer student.or optometry student Eccentric circles tmee-space tusion carck Laose prism tacily Cl,cunvergence insufficeny CITT,convergence insufficiency Life saver free-space fusion cards treatmer trial. Oprometry and Vistau Srkenre,Vol 82.N.7.Jely 2035 Copyright American Academy of Optometry.Unauthonzed reproducton of this article is prohibited

Sheard’s criterion (positive fusional vergence less than twice the near phoria21 or minimum positive fusional vergence of 15 baseout break), and a score of
9 on the CISS–V13. Table 1 provides a complete listing of the eligibility and exclusion criteria. Treatment Protocols The Ohio State University Optometry Coordinating Center, the data coordinating center for the study, randomly assigned eli￾gible patients with equal probability to pencil pushups, vision ther￾apy/orthoptics, and placebo vision therapy/orthoptics treatment arms. Randomization was accomplished on the study’s web site using blocks of six so the investigator could not predict the se￾quence of treatment assignments. To ensure approximately equal numbers of patients in each treatment arm at any given clinical center, randomization was performed separately for each site. Pencil Pushups Patients in the pencil pushups group were taught a pencil pushup procedure that included monitoring for suppression. The patient was instructed to hold a pencil at arm’s length directly between his or her eyes and an index card, which served as a suppression control, was placed on the wall 6 to 8 feet away. The patient was instructed look at the tip of the sharpened pencil and to try to keep the pencil point single while moving it toward his or her nose. If one of the cards in the background disappeared, the patient was instructed to stop moving the pencil and blink his or her eyes until both cards were present. The patient was told to continue moving the pencil slowly toward his or her nose until it could no longer be kept single and then to try to regain single vision. If the patient was able to regain single vision, he or she was asked to continue moving the pencil closer to his or her nose. If the patient could not regain single vision, he or she was instructed to start the procedure again. Patients were instructed to do three sets of 20 pushups per day at home, 5 days per week for 12 weeks, and this treatment required approximately 15 minutes per day. Before per￾forming the procedure at home, the patient had to demonstrate in the office that he or she understood and had the ability to perform the procedure according to the protocol. Office-Based Vision Therapy/Orthoptics (VT/Orthoptics) The vision therapy/orthoptics group received therapy adminis￾tered by a trained therapist during a weekly, 60-minute office visit, with additional procedures to be performed at home for 15 min￾utes a day, five times per week for 12 weeks. The office- and home-based procedures used are described in detail elsewhere9 and are listed in Table 2 along with a short description of each proce￾dure. The items listed in Table 2 are the specific procedures per￾formed by each patient in this treatment arm during the weekly, office-based vision therapy/orthoptics sessions. In addition, treat￾ment procedures were practiced at home. During a typical office￾based treatment session, the patient practiced four to five proce￾dures with constant supervision and guidance from the therapist. There were no diagnostic tests performed during these sessions. The therapist followed a very detailed and specific protocol from the CITT Manual of Procedures, which described the proper treat￾ment technique, amount of time the technique was to be done, expected performance, and the criteria required to advance to a more difficult level or to the next procedure in the treatment se￾TABLE 1. Eligibility and exclusion criteria Eligibility criteria Age 19–30 years inclusive Best-corrected visual acuity of 20/25 in both eyes at distance and near Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary Exophoria at near at least 4 greater than at far Insufficient positive fusional convergence (i.e., failing Sheard’s criterion21 or less than 15 break) Receded near point of convergence of greater than or equal to 6 cm break Appreciation of at least 500 seconds of arc on the forms part of the Randot Stereotest CI Symptom Survey–V13 (original 13-item version) score 9 Informed consent and willingness to participate in the study and be randomized Exclusion criteria CI previously treated with pencil pushups or office-based vision therapy/orthoptics (no more than 2 months of treatment within the past year) Amblyopia Constant strabismus History of strabismus surgery Anisometropia 1.50 D difference between eyes Prior refractive surgery Vertical heterophoria greater than 1 Systemic diseases known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves’ thyroid disease, myasthenia gravis, diabetes, and Parkinson disease Any ocular or systemic medication known to affect accommodation or vergence Monocular accommodative amplitude less than 4 D in either eye as measured by the pushup method Manifest or latent nystagmus Household member already enrolled in the CITT Any eye care professional, ophthalmic technician, medical student, or optometry student CI, convergence insufficiency; CITT, convergence insufficiency treatment trial. TABLE 2. Office-based vision therapy/orthoptics procedures Loose lens accommodative facility Letter chart accommodative facility Binocular accommodative facility Brock string Barrel card Vectograms Computer orthoptics (random dot stereogram procedure) Aperture rule trainer Eccentric circles free-space fusion cards Loose prism facility Life saver free-space fusion cards Convergence Insufficiency in Young Adults—Scheiman et al. E585 Optometry and Vision Science, Vol. 82, No. 7, July 2005

E586 Convergence Insufficiency in Young Adults-Scheiman al. encFigure I outines the trearment sequence When a proce-gence,accommodation,or sccd function.Examples induded dute was prescribed for home treatment,a handout with instrue-uingorams monoclady tomulre vergence therapy.com- rions wax given to the puaticnt. puter vergence therapy with no vergence changes and using mon. oculr prism (instcad of plus and minus lenses)to simulte accom- modative treatment. Placebo Office-Based Vision Therapy/Orthoptics (Placeho VT/Orthoptics) Recae esperiemoed therapists pnwided the teatments it was nct feasible to mask them to their parients'assigned treatment Like thevio theraprthopithe plactbo visionsoweversfollwell-definedp therapyiortboptic group received therapy administered by a for all treatments and was insructod to interact in an identical trainad therapist during a 60-minute office visit and were pre- fashion with patients in all treame groups Although ptienes scribed pruocdures to be performed at homc,15 minutes,five were obiously a of whether they wore asigned toaffic-hasd times pr weck for 12 wocks.The procedures for phocbo vision ament or pencil pushups,thosessied to offce-bsed tet therapyforthoptic were designed to simulate real vision therapy! ment were masked regarding whether they were assigned w real orhoptics procedures withour the expecif affecting ver vision therapy/orthoptics or placebo vision therapy'orthopics. Phase Cne Gross coveracnee.Pasitive Falotal Vergence and Moaocular Acommadative Therapy Teciiyues Gre Cotvenpetce Padtive Puscul Vergence lroek string Vectogrns IClw) Loose Lers Acconmodotive Rock Hard Card Cimeurr Urepe (RDSI Letter Chart Aoogmmodathe Rock Life Saver Cu山 Heme VTXrthopeics Brock Sring Borel Card Lome Lens Arcomrmadalive Knck Life Srer Cants Leter Chant Acconodutive Rock HTS Prase Two Ramp Fwicaal Yensence and Manocubr Acromrndathe Therapy Tecowigues Ranp Fusonal Verpence Corpuler Orthopties (RDX) Lctier Chrt Acccmmodative Kndk Aportue Bule Futntre Cirde Heme VT/Orthopeies Randoen Det Card 【ooe Irme Aconnrodtive Therapy Eccenmrio Circles II'S (hase out,heae in.and autrelide wrgeno) Prase Three Jump Fusioeal Vergence aed Binacubr Accommodlive Facility funp Fusonal Vergence Bingculer Mooummodaliee Fucilite Rinocilar Mecommodathee Facility Compuler Detopscs (RDS) Eoogtig Crale leme VT/Orthopeics Loose Prismn Jampo Hirncbe Accommgdaive Fadlity Random Dot Card Maindesasce therapy (for treated patien) FIGLRE 1. Visnn therapy (V)forthnptics peerrol Opronetry and Viaiau Scimer,Val K2,Na.7,Jely 235 Copyright American Academy of Optometry.Unauthonzed reproduction of this artcle is prohibited

quence. Figure 1 outlines the treatment sequence. When a proce￾dure was prescribed for home treatment, a handout with instruc￾tions was given to the patient. Placebo Office-Based Vision Therapy/Orthoptics (Placebo VT/Orthoptics) Like the vision therapy/orthoptics group, the placebo vision therapy/orthoptics group received therapy administered by a trained therapist during a 60-minute office visit and were pre￾scribed procedures to be performed at home, 15 minutes, five times per week for 12 weeks. The procedures for placebo vision therapy/orthoptics were designed to simulate real vision therapy/ orthoptics procedures without the expectation of affecting ver￾gence, accommodation, or saccadic function. Examples included using stereograms monocularly to simulate vergence therapy, com￾puter vergence therapy with no vergence changes, and using mon￾ocular prism (instead of plus and minus lenses) to simulate accom￾modative treatment. Because experienced therapists provided the treatments, it was not feasible to mask them to their patients’ assigned treatment groups. However, each therapist followed a well-defined protocol for all treatments and was instructed to interact in an identical fashion with patients in all treatment groups. Although patients were obviously aware of whether they were assigned to office-based treatment or pencil pushups, those assigned to office-based treat￾ment were masked regarding whether they were assigned to real vision therapy/orthoptics or placebo vision therapy/orthoptics. FIGURE 1. Vision therapy (VT) /orthoptics protocol E586 Convergence Insufficiency in Young Adults—Scheiman et al. Optometry and Vision Science, Vol. 82, No. 7, July 2005

Convergcnce Insufficiency in Young AdultsScheiman ct al.E587 TABLE 3. Study population demographics and clinical measures at enrollment Characleristic Overall Dropouts Completers n=46 (n-6) n.=40的 Age in years,mean ISD) 24.33.60 24.24.10 24.43.5月 Gondee Male 28.3 33.3 27.5 %Female 71.7 66.7 72.5 Race White 56.5 33.3 600 %Black 6.3 16.7 5.0 Hispunic 17.4 16.7 17.5 Asian 10.9 333 7.5 Other H.7 01 10.0 CISS-V15 score,mean (5D] 37.39.3) 38.011.2 37.39.11 Near point of comvegence (cml,mean (SD) Break 13.57.1) 14.966 13.2721 Recowery 17.19.2) 2027列 16.69.3 Accommodation (OD only),mean (SD) Amplitude (D) 13.74.4) 13.44 13.04.4 Facility (cprnl 7.85.5) 5.1400 8356 Exuphuria△l,I比anD) Distance 2.42.9助 1210 2.63.11 Near 10.64.8) 6.71.00 1124.9到 Positive fusional wergence at near ()mean (SDI Blur 944.刀 7930 9,643引 Break 11.85.40 8.7B1 12.3551 Rocovcry 7.84.9的 4.622 835.0 Relractive error (spherical equivaler.mean (SD) 00 -0.9219 0080.5 -1072.0 为 -0.971.9 -0.120.41 -1.112W A prism diopter 5D,standard deviation cpm,cycles/min. follow-up visits,an examiner who was masked to the patient's Patiemts randomi时 teatment gmoup adminisrered the CISS-V15.cover testing at dis- 但-46) tance and ncar,ncar point of convergence,and poirive fasianal vergenoe at near. 15 assigned to 17 assigned to 14 assigned to vision theraps Placcbo vision Adherence to the Treatment Protocol ortboptics Pencil push-ups therapyortheptics Adherence to the home trearment protocol was assegsed by hav- ing the patient maintain a calendar on which the treatment (min- utes of bome therapy)perfocmed each day was logged.The calen 3 lost to follow-up 2 lost to follou-up 1 lost to follow up dars were reviewed at follow up visits,and the therapist maden 。wgT山对(1i 。续ma日《1} 。di5 nct wish to assessment of the pacient's adherence to the prescnbed trearment did not wsh fanizipule(1 标方e2) bed roet (11 (escellent was 75-100%of prescribed treamnent completed.good 50-74%.Git25-499%,ndat三259%. At the Coordinating Center,each followup examination form was reviewed to assess whether the investigator properly followed 12 included i 15 included in 13 included in the examination and trearment protocol,and any necessary feed. analysis anzlsis analysis bck was provided to the investigator. FIGURF 2. Flowchart shuwintg slucly tompktion br each goup. Outcome Measures and Criteria for Success Examination Procedures Patients with Cl who sock treatment do so to eliminate their symptoms.Thus,treatment for CI can only be considered success- Proencal-aperified fallow-ap visits were conducted after 41 full if the putient has fewer sympeoms afier treatment.To measure and 8+1 wrcks of treatment.The primary outcome assessment symptoms and changes in symptoms,we used the soorc on the Cl was made at the visit after 12 2 wecks of trcatmnt.At thoe Symptom Survay-V15 as the primary outcome measune.Our pre- 0 camnbry and2 au Srimen,Yol2,k不，t5 Copyright American Academy of Optometry.Unauthonzed reproduction of this artcle is prohibited

Examination Procedures Protocol-specified follow-up visits were conducted after 4 1 and 8 1 weeks of treatment. The primary outcome assessment was made at the visit after 12 2 weeks of treatment. At these follow-up visits, an examiner who was masked to the patient’s treatment group administered the CISS-V15, cover testing at dis￾tance and near, near point of convergence, and positive fusional vergence at near. Adherence to the Treatment Protocol Adherence to the home treatment protocol was assessed by hav￾ing the patient maintain a calendar on which the treatment (min￾utes of home therapy) performed each day was logged. The calen￾dars were reviewed at follow-up visits, and the therapist made an assessment of the patient’s adherence to the prescribed treatment (excellent was 75–100% of prescribed treatment completed, good 50 –74%, fair 25– 49%, and poor 25%). At the Coordinating Center, each follow-up examination form was reviewed to assess whether the investigator properly followed the examination and treatment protocol, and any necessary feed￾back was provided to the investigator. Outcome Measures and Criteria for Success Patients with CI who seek treatment do so to eliminate their symptoms. Thus, treatment for CI can only be considered success￾ful if the patient has fewer symptoms after treatment. To measure symptoms and changes in symptoms, we used the score on the CI Symptom Survey-V15 as the primary outcome measure. Our pre￾TABLE 3. Study population demographics and clinical measures at enrollment Characteristic Overall (n
46) Dropouts (n
6) Completers (n
40) Age in years, mean (SD) 24.3 (3.6) 24.2 (4.1) 24.4 (3.5) Gender % Male 28.3 33.3 27.5 % Female 71.7 66.7 72.5 Race % White 56.5 33.3 60.0 % Black 6.5 16.7 5.0 % Hispanic 17.4 16.7 17.5 % Asian 10.9 33.3 7.5 % Other 8.7 0.0 10.0 CISS-V15 score, mean (SD) 37.3 (9.3) 38.0 (11.2) 37.3 (9.1) Near point of convergence (cm), mean (SD) Break 13.5 (7.1) 14.9 (6.6) 13.2 (7.2) Recovery 17.1 (9.2) 20.2 (7.9) 16.6 (9.3) Accommodation (OD only), mean (SD) Amplitude (D) 13.7 (4.4) 13.4 (4.8) 13.8 (4.4) Facility (cpm) 7.8 (5.5) 5.1 (4.0) 8.3 (5.6) Exophoria (‚), mean (SD) Distance 2.4 (2.9) 1.2 (1.0) 2.6 (3.1) Near 10.6 (4.8) 6.7 (1.0) 11.2 (4.9) Positive fusional vergence at near (‚), mean (SD) Blur 9.4 (4.2) 7.9 (3.0) 9.6 (4.3) Break 11.8 (5.4) 8.7 (3.4) 12.3 (5.5) Recovery 7.8 (4.9) 4.6 (2.2) 8.3 (5.0) Refractive error (spherical equivalent), mean (SD) OD 0.92 (1.9) 0.08 (0.5) 1.07 (2.0) OS 0.97 (1.9) 0.02 (0.4) 1.11 (2.0) ‚, prism diopter; SD, standard deviation; cpm, cycles/min. FIGURE 2. Flowchart showing study completion for each group. Convergence Insufficiency in Young Adults—Scheiman et al. E587 Optometry and Vision Science, Vol. 82, No. 7, July 2005

E588 Convergence Insufficiency in Young Adults-Schoiman ct al. liminary work during this study demonstrated that the majority of wock outme visit of the enrlled patients with Cl asigned to the these adult patients with CI had CI Symptom Survey scores of 21 placebo vision therapy group.It wasasmed that the psr or higher (sensitivity -97.8%).whereas those with normal hin- ment mean of the most efiective treatment group would approxi- ocular vision predominantly scored below 16 (specificiry mate the mean among patients with normal binocular vision.that 85.7%).We,therefore.defined a Cl Symptom Score of <21 the mean for the placebo group would decrease 20%from ics after 12 weeks of treatment as a successful ourcome.We also eval- baseline value,and that the mean for the remining,rreatment uated two scondary outcome measures (near point of convergence group would fall in the middle of these fint two groups.By asum and positive fusional vergence at near). ing that the men from the third treatment group would fal in the For most clinicians,the goal of the trearment for a patient with midd oftheothe two.the poerodetect differences is minimixed. Cl is not only to eliminate the person's sympcoms.but ako to That is,these asamptions about the mean values of the CISS for the improwe the patient's near point of convergence and positive fu- h生goup华yield the smalles value for power and are there6ee sional vergerxe at pear.Thus,we ued another set of criteria to most conervative.Even using these conservative assumptions,our define parients as "cured"or"improved."Patients who achieved power to detect diferences is extremely high at 99.6%6. scores of 21 on the CI Symptom Survey had a nommal near point ofcoevergence aud normal positive fusioeal vergence at near RESULTS were considered "cured."Patients who achieved a decteae in Enrollment symptoms(21 on the CI Sympeom Survey)and achieved normal values in eitler the near point of comvergence(cm)positive A toral of 46 patients were enrolled in the study berween No fusiooal vergence at near (passing Sheard's cricerionor15A vember 2000 and November 2001.The numher enrolled per site breald)were considered "improved" at the five sites ranged from one to 15 (modian -7.5).The mcan age was 24.3 years(SD-3.6):72%were female,57%were white, Statistical Methods 7%black.17%Hispanic,11%were Asian,and 9%6 other.At eligibaliry.the mean (SD)clinical findings for tbe enrolked parients No formal sample sixe calculations were performed a riori be. wee22(±2.9到exopboria at distance,.1la(±18 exopboria at cause ane of the goals of this pilor study was to esrimate the vari- near;near point of coavergence break/recovery of 13 (7.1) ability of our new outcome measure,the CISS-V15.At study com- cm/17 cm (9.2k:and pear positive fusional vergence break of pltion.the observed variability in the CISS-V15 was used to 12(±5.40 nd recovery82(±4.9.Tk3 provides the sx女 determine the statistical power available to decect meaningful dif. population demographics and clinical meares at dligibiliry. ferences among the three trearment groups.The caloulations were performed using PASS sofiware with a =0.05 and assuminga Patient Follow Up and Adherence to Treatment two-sided teg.The group means used in the cakulations were obtained from the mean CISS V15 soore of adult patients with The primary outcome examination was completed within the pormal binocular vision and the mean CISS V15 scoce at the 12. 12 2 week window by 12 of 15 (80%)parients assigned to vision TABLE 4. Stuy population demographics and clinical measures at randomization by treatment group assignment Chamceristic Pencil pushups Vision therapworthoptics Placobo vision therapyorthoptics m=17乃 n=15) n=14 Mean age (SD) 24.4月.41 23.739 25.105 Gencker %Male 29.4 267 286 Fcmale 20.6 733 71.4 Kace %White 64.7 40.0 643 Black 5.9 6.7 7.1 %Hispanic 11.8 200 214 Asian 5.9 26.7 0.0 %Other 11.8 6.7 7.1 Accommodation Mean amplitude (D)SD) 8.025升 8433切 8024周 Acan facility (CPM排SD 765.00 8.75 735.9纫 Phria (Al Mean distance ISD) 2.1exD2.3 2.7ew040 2.6e0220 Mean near [SD! 10.H0x04.5 10.9005.到 10.0Pw04.11 Refractive error (spherical ecuivalen Mean OD ISD -0.67(1.7 -1312.00 -0812.01 Mean O6 (5DI 078(1,0 -133Q0明 -081Q,1 5D,standard deviation:CPM,cycles/min;prism diopler. atry an Visiau出mAd2.7,J2nm5 Copyright American Academy of Optometry.Unauthonzed reproduction of this artcle is prohibited

liminary work during this study demonstrated that the majority of these adult patients with CI had CI Symptom Survey scores of 21 or higher (sensitivity
97.8%), whereas those with normal bin￾ocular vision predominantly scored below 16 (specificity
85.7%).22 We, therefore, defined a CI Symptom Score of 21 after 12 weeks of treatment as a successful outcome. We also eval￾uated two secondary outcome measures (near point of convergence and positive fusional vergence at near). For most clinicians, the goal of the treatment for a patient with CI is not only to eliminate the person’s symptoms, but also to improve the patient’s near point of convergence and positive fu￾sional vergence at near. Thus, we used another set of criteria to define patients as “cured” or “improved.” Patients who achieved scores of 21 on the CI Symptom Survey and had a normal near point of convergence and normal positive fusional vergence at near were considered “cured.” Patients who achieved a decrease in symptoms (21 on the CI Symptom Survey) and achieved normal values in either the near point of convergence (6 cm) or positive fusional vergence at near (passing Sheard’s criterion21or
15‚ break) were considered “improved.” Statistical Methods No formal sample size calculations were performed a priori be￾cause one of the goals of this pilot study was to estimate the vari￾ability of our new outcome measure, the CISS-V15. At study com￾pletion, the observed variability in the CISS-V15 was used to determine the statistical power available to detect meaningful dif￾ferences among the three treatment groups. The calculations were performed using PASS software with 
0.05 and assuming a two-sided test. The group means used in the calculations were obtained from the mean CISS-V15 score of adult patients with normal binocular vision and the mean CISS-V15 score at the 12- week outcome visit of the enrolled patients with CI assigned to the placebo vision therapy group.22 It was assumed that the posttreat￾ment mean of the most effective treatment group would approxi￾mate the mean among patients with normal binocular vision, that the mean for the placebo group would decrease 20% from its baseline value, and that the mean for the remaining treatment group would fall in the middle of these first two groups. By assum￾ing that the mean from the third treatment group would fall in the middle of the other two, the power to detect differences is minimized. That is, these assumptions about the mean values of the CISS for the three groups yield the smallest value for power and are therefore the most conservative. Even using these conservative assumptions, our power to detect differences is extremely high at 99.6%. RESULTS Enrollment A total of 46 patients were enrolled in the study between No￾vember 2000 and November 2001. The number enrolled per site at the five sites ranged from one to 15 (median
7.5). The mean age was 24.3 years (SD
3.6); 72% were female, 57% were white, 7% black, 17% Hispanic, 11% were Asian, and 9% other. At eligibility, the mean (SD) clinical findings for the enrolled patients were 2 ( 2.9) exophoria at distance; 11 ( 4.8) exophoria at near; near point of convergence break/recovery of 13 ( 7.1) cm/17 cm ( 9.2); and near positive fusional vergence break of 12 ( 5.4) and recovery 8 ( 4.9). Table 3 provides the study population demographics and clinical measures at eligibility. Patient Follow Up and Adherence to Treatment The primary outcome examination was completed within the 12 2-week window by 12 of 15 (80%) patients assigned to vision TABLE 4. Study population demographics and clinical measures at randomization by treatment group assignment Characteristic Pencil pushups (n
17) Vision therapy/orthoptics (n
15) Placebo vision therapy/orthoptics (n
14) Mean age (SD) 24.4 (3.4) 23.7 (3.9) 25.1 (3.5) Gender % Male 29.4 26.7 28.6 % Female 70.6 73.3 71.4 Race % White 64.7 40.0 64.3 % Black 5.9 6.7 7.1 % Hispanic 11.8 20.0 21.4 % Asian 5.9 26.7 0.0 % Other 11.8 6.7 7.1 Accommodation Mean amplitude (D) (SD) 8.0 (2.5) 8.4 (3.3) 8.0 (2.4) Mean facility (CPM) (SD) 7.6 (5.0) 8.7 (5.8) 7.3 (5.9) Phoria (‚) Mean distance (SD) 2.1 exo (2.3) 2.7 exo (4.0) 2.6 exo (2.2) Mean near (SD) 10.8 exo (4.5) 10.9 exo (5.9) 10.0 exo (4.1) Refractive error (spherical equivalent) Mean OD (SD) 0.67 (1.7) 1.31 (2.0) 0.81 (2.0) Mean OS (SD) 0.78 (1.7) 1.33 (2.0) 0.81 (2.1) SD, standard deviation; CPM, cycles/min; ‚ prism diopter. E588 Convergence Insufficiency in Young Adults—Scheiman et al. Optometry and Vision Science, Vol. 82, No. 7, July 2005

Conwergence Insufficiency in Young Adults-Scheiman et al.E589 TABLE 5. Comparing treatment proups with mspect to clinical measunes at eligibility and the 12-week outcome examination Characterislic eK国5hup路 Vision theregworthuptis Plactbo visin theraporthoplics m15) =12 =13 Mean (5D)CI Symptom Survey-V15 score at cligibility 37.677 365思7) 375411.41 Aller 4 weeks 30.89.91 3309.40 32.811161 After 8 weeks 27.9731 2629.30 27.34118 Aftor 12 woeks 26.573引 2071024 25.211D3别 Mean (5D)NPC break at eligibility 12.5cm6.6 128cm7.7 14.5cm7.8 After 4 weeks 83m44 740m3.5 115mG4 Alter 8 weeks 87m64明 60mG8 1D5m5.11 After 12 wecks 7.0cm4.1 53cm1.7 9.6cm40 Mean (SD)PFV hreak at eligibilily 13.6△7.1) 113△/4.3 11.54.40 Aftor 4 wooks 192△9.60 17H7.1 12.95.3引 After 8 weelks 22.6△1171 23311.Dm 16272引 After 12 weeks 24.2△12.59 29710.8 17.55.7 A prism diopter,SD,sandard deviaticn: NPC near point of convergence:PFV,positive fusional wergence therapyfortboptics,13of 14 (93%)patients asigned to placebo Primary Outcome Measure:Convergence vision therapylorthoptios,and 15 of 17 (88%)puaticnts assigned to Insufficiency Symptom Score pencil pushups The compltion rate was not related to tratmnt asignment(chi-squared p value =01.6).Of the six patients not The CI Symptom Survey soore showed a significant rducion completing the primary outcome examination.two were lost to in symptoms for paticnts in cach of the three treatment groups (p follow up.two decided they were too busy for the demands of the 0.001 fur cach group).Patients in the vision thurapyforthoptics study protocl,on was pat on pregnaniy-rclatod bednest,and one group showed a rduction in symptoms frum 36.5 8.7 to 20.7 was randomnized even though the patient had indicated that he or 12.2 (Table 5).Patients in the placebo vision therapyorthoptics she was not interested in prticipxating in the study (Fig.2).There and pencil pushaps groups ako showed a decr in mean symp- omrm(placcho from375±114tw25.2±10.3pcn园 was a statistically significant differerce in mean near phoria be tween thasc paticnts lost to folluw up (mcan=6.7[1.0]cxo) pushups37.6±7.7o265±7.3功，though this char零snot and those patientscomnpleting the study (mcan-11.2%exo,SD- as large as that observed in the vision therapy/orthoptic group. There were no statistical ditferences in the CI Sympcom Survey 4.9,p D.008).No other statistically significant or clinically reevant differences in demographic o clinical measure t eligibal scorc amang the three treatment groupe at eligibality (p=0.86)ar at the completion of treatment (p -0.15). iry were found (all p values 0.10). Figure 3 shows the mean Symptom Survey soore at dligibility Given the relative comparability of those patients who cum- and after 4.B,and 12 weeks of treatment for patients in each plted the study and thase puitients who chose to drop nut or did not complete the outcame examination within the windkw,all subsequent results are reported for only those parients with datat the 12-woek visit.Further analses were perfurmed after imputing ◆甲T鲁0BVI女bo outcome values for those patients lost to follow up.That is,the 35 valne a the lat available esamination was ued for cach parirnt who did not complete the stucy.Far five of the sis patients the only dara available were collected ar the dgbiliry visit.When differences in statistical analyses were found,the resules from anal- yses with imputed data are also repored. 25 20 At相1eT Eligibility Data Eligibility demographic and clinical data for sudy patients are Ebgimbry 12 summarized in Tables and 5 by group asignment.There were no week statistically signifkcant or clinically relevant differences betwoen FIGURE 3. parients assigned to the three treatment groups (p0.40 for all Changes in the sympiom score on the Comvergence Iroufficiency Symp comparisnns). tom Surv after 4,8,and 12 werks nf treatment for rch earment gmup 0 rometry and Viaiau Scimer,Val2,a.去，山5 Copyright American Academy of Optometry.Unauthonzed reproduction of this artcle is prohibited

therapy/orthoptics, 13 of 14 (93%) patients assigned to placebo vision therapy/orthoptics, and 15 of 17 (88%) patients assigned to pencil pushups. The completion rate was not related to treatment assignment (chi-squared p value
0.66). Of the six patients not completing the primary outcome examination, two were lost to follow up, two decided they were too busy for the demands of the study protocol, one was put on pregnancy-related bedrest, and one was randomized even though the patient had indicated that he or she was not interested in participating in the study (Fig. 2). There was a statistically significant difference in mean near phoria be￾tween those patients lost to follow up (mean
6.7 [ 1.0] exo) and those patients completing the study (mean
11.2 exo, SD
4.9, p
0.008). No other statistically significant or clinically relevant differences in demographic or clinical measures at eligibil￾ity were found (all p values 0.10). Given the relative comparability of those patients who com￾pleted the study and those patients who chose to drop out or did not complete the outcome examination within the window, all subsequent results are reported for only those patients with data at the 12-week visit. Further analyses were performed after imputing outcome values for those patients lost to follow up. That is, the value at the last available examination was used for each patient who did not complete the study. For five of the six patients, the only data available were collected at the eligibility visit. When differences in statistical analyses were found, the results from anal￾yses with imputed data are also reported. Eligibility Data Eligibility demographic and clinical data for study patients are summarized in Tables 4 and 5 by group assignment. There were no statistically significant or clinically relevant differences between patients assigned to the three treatment groups (p 0.40 for all comparisons). Primary Outcome Measure: Convergence Insufficiency Symptom Score The CI Symptom Survey score showed a significant reduction in symptoms for patients in each of the three treatment groups (p  0.001 for each group). Patients in the vision therapy/orthoptics group showed a reduction in symptoms from 36.5 8.7 to 20.7 12.2 (Table 5). Patients in the placebo vision therapy/orthoptics and pencil pushups groups also showed a decrease in mean symp￾tom score (placebo from 37.5 11.4 to 25.2 10.3, pencil pushups 37.6 7.7 to 26.5 7.3), although this change was not as large as that observed in the vision therapy/orthoptic group. There were no statistical differences in the CI Symptom Survey score among the three treatment groups at eligibility (p
0.86) or at the completion of treatment (p
0.15). Figure 3 shows the mean CI Symptom Survey score at eligibility and after 4, 8, and 12 weeks of treatment for patients in each TABLE 5. Comparing treatment groups with respect to clinical measures at eligibility and the 12-week outcome examination Characteristic Pencil pushups (n
15) Vision therapy/orthoptics (n
12) Placebo vision therapy/orthoptics (n
13) Mean (SD) CI Symptom Survey-V15 score at eligibility 37.6 (7.7) 36.5 (8.7) 37.5 (11.4) After 4 weeks 30.8 (9.9) 33.0 (9.4) 32.8 (11.6) After 8 weeks 27.9 (7.3) 26.2 (9.3) 27.3 (11.8) After 12 weeks 26.5 (7.3) 20.7 (10.2) 25.2 (10.3) Mean (SD) NPC break at eligibility 12.5 cm (6.6) 12.8 cm (7.7) 14.5 cm (7.8) After 4 weeks 8.3 cm (4.4) 7.4 cm (3.5) 11.5 cm (3.4) After 8 weeks 8.7 cm (6.4) 6.0 cm (3.8) 10.5 cm (5.1) After 12 weeks 7.8 cm (4.1) 5.3 cm (1.7) 9.6 cm (4.0) Mean (SD) PFV break at eligibility 13.6‚(7.1) 11.3‚(4.3) 11.5‚(4.4) After 4 weeks 19.2‚(9.6) 17.8‚(7.1) 12.9‚(5.3) After 8 weeks 22.6‚(11.7) 23.3‚(11.0) 16.2‚(7.2) After 12 weeks 24.2‚(12.5) 29.7‚(10.8) 17.5‚(5.7) ‚, prism diopter; SD, standard deviation; NPC, near point of convergence; PFV, positive fusional vergence. FIGURE 3. Changes in the symptom score on the Convergence Insufficiency Symp￾tom Survey after 4, 8, and 12 weeks of treatment for each treatment group. Convergence Insufficiency in Young Adults—Scheiman et al. E589 Optometry and Vision Science, Vol. 82, No. 7, July 2005

E590 Convergence Insufficicncy in Young Adults Scheiman ct al. treatment arm.After 12 weeks of treatment,the mean CI Symp-gmups bccomes nonsignificant (p =D.27).The mean for partienes tom Survey son for paricnts assignod to viion therapylorthoptics in the vision therapyforthoptics group inasd t7.14.3cm. deoreased to a kvel that would be considered nonsymptomatic which is no longer significantly different from the mean value for (i.e.,a CISS-V15 score of <21).Neither the mean score for the patients in the placebo vison therapy/orthoptics group (mcan- pencil pushups group nor placebo vision tberapy/arthopeics group 9.5±39cmp-025). ever fell below this level. Figure 5 shows the mean posirive fusional vergence at near at cligibility and aftr4,8,and 12 wocks of treatment for paticnts in Secondary Outcome Measures each treatment arm.The positive fusional vergerce break at near increased significanty in the vision therapy/orthoptics groupfrom Fanure 4 shorws the mean neat paint af convergencr at eligibiliry 11.3A+4.3 to 29.7=10.8 (p-0.001).Patients in the placebo and after 4.8,and 12 wreks of tnearment for patients in cach vision therapyforthoptics group experienced a statistically signifi trcatment arm.Therc wen statistically significant changes in the cant impruwument from 11.5 4.4 tu 17.5 5.7 (p -0.003) ncar point of comverpence in a groups.However,only the vision and those in the pencil pushups group improvement significantly therapyforthoptic group showed a clinically significant improve- fom13.61±7.1to242d±12.5p<0.0011.The mean ment (em ar less).The near point ofconvergence hreak improved positive fusional vergence breal valuesat the outcome visic differed in the viion therapy/orthoptios gruup dcreasing from 12.8 cm significanty berween the three groups(p-0002).The mean for 7.7 to 5.3 cm 1.7 (p -0.002).There was a statistically signifi- patients in the vision therapyforthoptic group was significantly cant impruvement in the mean near point of corvergence break ditierent (improved)compared with the mean for patients in the measurement in the pencil pushups group (12.5 cm6.6 to 7.8 pencil pushups group (p-0.04)and those in the placebo visio em 4.1,p =0.001)and the placcho visian therapy/orthopties therapy/orthopcics group (p-0.002).No difference was observed guup(14.5m±7.8m96cm±4.0p-0,04.although the berween the pencil pushups and placebo vision therapyforhoprics changes are not considered dinically significant.Sixty-seven per- upsp=036). cent (eight of 12)of the patients in the vision therapy/octhoptics group achieved a nommal near point of convergence break measure. ment of 6cm at the end of treatment,whereas 23.1%(3 of 1.3) Adherence to Treatment of the plactbo vision therapylerthoptics group and 4.7%(7 of T'o asscss adhercncc,the therapist asked the paticnt qucstions 15)of the pencil pushups group achived this result. about the home-based treatment and then answered the following A comparison of the mean values at the end of treatment dem question on the CIII follow-up form:"What percent of the time onstrated a significant difference in the near point of convergence do you feel the patient adhered to the treatment proooo"The break values berween the three treamment groups(p-0.02).Post choices wer09%.124%.25-499%,5074%.7599%,or hoc testing revealed that the mean ncar point ofcomergence break 100%. for the vision therapy/orthoptics group was significantly different There were no differenoes in the therapist's assesment of patient from the mean of the placebo vision therapy/orthoptics group (p adberence berween the three treatment groups at any visit.After4 0.02).There was no significant difference when comparing the weeks of treatment.the therapists estimated that 61.5%of patients pencil pashups group with the vision therapyforboptics group (p in the vision therspyforthoptics group,91.7%of patients in the -0.18)nor to the plactbo vision therapylorthoptio group (p- placcbo vision therapy/orthoptics group,and 61.5%of those in 0.43).If we compare the near point of comvergence break between the pencil pushups group were performing their home therapy at groups after imputing values for the six parients who did not com last 75%of the time (Kruskal-Wallis p-0.12).At 8 weels,the plete the entire 12 weeks of treatment.the difference berween therapiss'estimates were 69.2%for the vision therapyforthoptics +PPT●UBT3ebo +PpT#OBT女b间 Meas vale Sr nerral hiarcilar 25 o材白 10 20 1 Eligihility 4 12 Elgibility 12 Week Wrek FIGURE 4. FIGURE 5. Chunas in the rear puint of cumuryunve afler 4,8,and 12 wecks of Changes in he pusive lusiunal vergence a near afler 4,8,and 12 werk treatment for each trearment gmoup. of treatment for each treatment group. Oprometry and Vaiau Sckme%Vd足，k7,hHa Copyright American Academy of Optometry.Unauthonzed reproduction of this artcle is prohibited

treatment arm. After 12 weeks of treatment, the mean CI Symp￾tom Survey score for patients assigned to vision therapy/orthoptics decreased to a level that would be considered nonsymptomatic (i.e., a CISS-V15 score of 21). Neither the mean score for the pencil pushups group nor placebo vision therapy/orthoptics group ever fell below this level. Secondary Outcome Measures Figure 4 shows the mean near point of convergence at eligibility and after 4, 8, and 12 weeks of treatment for patients in each treatment arm. There were statistically significant changes in the near point of convergence in all groups. However, only the vision therapy/orthoptics group showed a clinically significant improve￾ment (6 cm or less). The near point of convergence break improved in the vision therapy/orthoptics group decreasing from 12.8 cm 7.7 to 5.3 cm 1.7 (p
0.002). There was a statistically signifi￾cant improvement in the mean near point of convergence break measurement in the pencil pushups group (12.5 cm 6.6 to 7.8 cm 4.1, p
0.001) and the placebo vision therapy/orthoptics group (14.5 cm 7.8 to 9.6 cm 4.0, p
0.04), although the changes are not considered clinically significant. Sixty-seven per￾cent (eight of 12) of the patients in the vision therapy/orthoptics group achieved a normal near point of convergence break measure￾ment of 6 cm at the end of treatment, whereas 23.1% (3 of 13) of the placebo vision therapy/orthoptics group and 46.7% (7 of 15) of the pencil pushups group achieved this result. A comparison of the mean values at the end of treatment dem￾onstrated a significant difference in the near point of convergence break values between the three treatment groups (p
0.02). Post hoc testing revealed that the mean near point of convergence break for the vision therapy/orthoptics group was significantly different from the mean of the placebo vision therapy/orthoptics group (p
0.02). There was no significant difference when comparing the pencil pushups group with the vision therapy/orthoptics group (p
0.18) nor to the placebo vision therapy/orthoptics group (p
0.43). If we compare the near point of convergence break between groups after imputing values for the six patients who did not com￾plete the entire 12 weeks of treatment, the difference between groups becomes nonsignificant (p
0.27). The mean for patients in the vision therapy/orthoptics group increased to 7.1 4.3 cm, which is no longer significantly different from the mean value for patients in the placebo vision therapy/orthoptics group (mean
9.5 3.9 cm, p
0.25). Figure 5 shows the mean positive fusional vergence at near at eligibility and after 4, 8, and 12 weeks of treatment for patients in each treatment arm. The positive fusional vergence break at near increased significantly in the vision therapy/orthoptics group from 11.3 4.3 to 29.7 10.8 (p
0.001). Patients in the placebo vision therapy/orthoptics group experienced a statistically signifi￾cant improvement from 11.5 4.4 to 17.5 5.7 (p
0.003) and those in the pencil pushups group improvement significantly from 13.6 7.1 to 24.2 12.5 (p  0.001). The mean positive fusional vergence break values at the outcome visit differed significantly between the three groups (p
0.002). The mean for patients in the vision therapy/orthoptics group was significantly different (improved) compared with the mean for patients in the pencil pushups group (p
0.04) and those in the placebo vision therapy/orthoptics group (p
0.002). No difference was observed between the pencil pushups and placebo vision therapy/orthoptics groups (p
0.36). Adherence to Treatment To assess adherence, the therapist asked the patient questions about the home-based treatment and then answered the following question on the CITT follow-up form: “What percent of the time do you feel the patient adhered to the treatment protocol?” The choices were: 0%, 1–24%, 25– 49%, 50 –74%, 75–99%, or 100%. There were no differences in the therapist’s assessment of patient adherence between the three treatment groups at any visit. After 4 weeks of treatment, the therapists estimated that 61.5% of patients in the vision therapy/orthoptics group, 91.7% of patients in the placebo vision therapy/orthoptics group, and 61.5% of those in the pencil pushups group were performing their home therapy at least 75% of the time (Kruskal-Wallis p
0.12). At 8 weeks, the therapists’ estimates were 69.2% for the vision therapy/orthoptics FIGURE 4. Changes in the near point of convergence after 4, 8, and 12 weeks of treatment for each treatment group. FIGURE 5. Changes in the positive fusional vergence at near after 4, 8, and 12 weeks of treatment for each treatment group. E590 Convergence Insufficiency in Young Adults—Scheiman et al. Optometry and Vision Science, Vol. 82, No. 7, July 2005

Convergence Insufficency in Young Adults-Scheiman ot al.E591 gruup,9 for the placcbo vision therapyforhoptics group,and Howver,among thusc parients assigned placcbo vision thurapy, 61.5%for the pencil pushups group (Kruskal-Wallis p-0.07). the percentage choosing "placebo"was not significantly different The percentage of patients estimated to adhere to home therapy at from%(p-0.083).This lack of significance could certainly be least 75%of the time decreased for all three trearment groups at the attributed in part to the small sample sie (n-13).Although not 12.week visir,but the estimates were still not significantly different significant,it is important to note that parients assigned to placebo from each other.In the vision therapy/orthoptics group,therapists were more likely to respond "visicn therapy."Thus,it would ap- estimated that 0.0%of the patients performed their home ther pear that successful masking of treatment assignment was achieved apy at least 75%of the time.This compares with the 69.2%esti in the group asigned to placebo vision therapy. maed for patients in the placebo von therapyforthoptics group and 8G7%estimated for pacients in the pencil pushups group (Kruskal-Wallis p =0.08). "Cured"and #Improved"Criteria Patients who achieved a soore of <21 on the CISS-V15 and had Placebo Treatment-Were Patients Masked? both a normal near point of comvergence and normal positive fusional vergence at near were considered "cured."In the vision To detcrmine the cffuctivenoss of masking the patients assigned therapyorthopics group.three of 12 (25.0)parients achieved to the two offioe-bastd treatments (i.e,vision therapy/orthoptics these criteria.whereas no patients in the placebo vision therapy! and placebo vion therapyforthoptics).patients were asked at the orthoptics group or in pencil pushups did so.Patients who 12 week examination if they thought they were randomized into achieved a decrease in sympcoms (21 on the CI Symptom Sur the "true"or the"placebo"treatment.In addition,they were asked vey-V15)and achieved normal values in either the near point of honw sune they wene about their answer.Tbe results (lable 6)indi- convergence or positive fusional verence at near were comidered caed that 75%of the patients assigned to placcbo vision therapy "improved."In the vision therapylorthopeics group,three of 12 orthoptics believed they had been assigned to the real vision ther (25%)patients achievedl this criteria.wherras rwo of 13(15.4%)in apyforthoptics group and%of these were very sure or pretry the placebo vision therapyforthoptics group and rwo of 15 sure of their answer.Of the patients assigned to real vision therapy 《l3.3%)i白pencil pushups group did so orthoptics.90%believed they had been assigned to real vision therapyforthoptics group and all were very sure or prety sure of their answer. DISCUSSION It could be argued that ifa patient was efully mased to In this first randomized,placebo-controlled,multicenter clini creatment assignment,that the patient would be equay likely to cal trial studying the treament ofsympcomatic CI in young adules. choose"vision therapy"or"placeho"when asked about perceived office-based vision therapy/arthoptics improved the signs associ- group assignment.This would equate to a 50/50 split in the per ated with Cl.Both the verage near point of cnmvergence and the centige responding 'vision therapy"o placebo."For those pa aw口posirive fisional灯ngenoe at near impronod t0 ronghly tients assigned to vision therapy.significantly more chose "vision normal clinical values,altbough 58%of the patients in this group therapy"than would have been expected by chanxce (p =0.011). were still considered to he symptomatic after 12 weeks of treat- ment.There were seatistically significant hut not clinscally relevant TABLE 6. impronvements in both the man near poine ofcnmvengence and the Perception of treatment group assignment versus actual mean poitive fiional vergence hreak at near in the pencil pushups assigned treatment group-werk 12 visit and plocbo office-basd vision therapyforthoptics groups In ad- dition.0%of those in the pencil pushups treament group and Patients assigned to vision therapy/orthoplics 69 of thase in the placcho vision therapylarthopeics group were Paticnts Perccnt Percent prety still considered to he symptomatie after 12 wreks of treatment. believing reporling sure or very If we instead consider boch symptom level and dinical findings they were specilic group sure of answer o chssi折p四cients as"cured"or"improm,”patients noxiving assigned to: vision therapyorthoptics agin fared beter than patients in cither Vision therap 9D0 1000 of the ather two treatment groups.Afier 12 wecks of trarment, orthoptics 50%of ptients in the vision therapylorthopeics group were cither P风ebo visin 1D0 00 "oured"(thnc of 12 or 25%)or"improved"(throe of12 or 25%). 1her可nk0民s In cuntrast,none of the patients asigned to pencil pushups and Patients assigned to placeho vision theraprworthoptics placebo vision therapyforthoptics gmup were "cured,"and only Patients Percont Percent pretry two of 13(15%)in the pencil pushupsand two of 15 (13%h)in the believing reporling sure or very placcbo vision therapyforthopties groupwer"impnwod. they were specific罗uup sure of answer Thex findingsa spising in light of pnvious studics demon- assipned to strating a significant decrease in symptoms after orthoptic treatment Vision therapy 75.0 44.4 for Cl in adults.Boch Cooper and Grisham,in reviewing the orthoptics mpoeted that over of parients with CI reportd climi- PLcebo vision 250 333 marion of ther ymptoms.Most of the studies rvicwod by thes au- therapnorthoplcs thors nported on adult patients with Cl.However,thee findings were basd on papers that were rerospective,uncontrolkd anddd not Oprometry and Vistau Srkenre,Vol 82.N.7.Jely 2035 Copyright American Academy of Optometry.Unauthonized reproduction of this artcle is prohibited

group, 91.7% for the placebo vision therapy/orthoptics group, and 61.5% for the pencil pushups group (Kruskal-Wallis p
0.07). The percentage of patients estimated to adhere to home therapy at least 75% of the time decreased for all three treatment groups at the 12-week visit, but the estimates were still not significantly different from each other. In the vision therapy/orthoptics group, therapists estimated that 50.0% of the patients performed their home ther￾apy at least 75% of the time. This compares with the 69.2% esti￾mated for patients in the placebo vision therapy/orthoptics group and 86.7% estimated for patients in the pencil pushups group (Kruskal-Wallis p
0.08). Placebo Treatment—Were Patients Masked? To determine the effectiveness of masking the patients assigned to the two office-based treatments (i.e., vision therapy/orthoptics and placebo vision therapy/orthoptics), patients were asked at the 12-week examination if they thought they were randomized into the “true” or the “placebo” treatment. In addition, they were asked how sure they were about their answer. The results (Table 6) indi￾cated that 75% of the patients assigned to placebo vision therapy/ orthoptics believed they had been assigned to the real vision ther￾apy/orthoptics group and 44% of these were very sure or pretty sure of their answer. Of the patients assigned to real vision therapy/ orthoptics, 90% believed they had been assigned to real vision therapy/orthoptics group and all were very sure or pretty sure of their answer. It could be argued that if a patient was successfully masked to treatment assignment, that the patient would be equally likely to choose “vision therapy” or “placebo” when asked about perceived group assignment. This would equate to a 50/50 split in the per￾centage responding “vision therapy” or “placebo.” For those pa￾tients assigned to vision therapy, significantly more chose “vision therapy” than would have been expected by chance (p
0.011). However, among those patients assigned to placebo vision therapy, the percentage choosing “placebo” was not significantly different from 50% (p
0.083). This lack of significance could certainly be attributed in part to the small sample size (n
13). Although not significant, it is important to note that patients assigned to placebo were more likely to respond “vision therapy.” Thus, it would ap￾pear that successful masking of treatment assignment was achieved in the group assigned to placebo vision therapy. “Cured” and “Improved” Criteria Patients who achieved a score of 21 on the CISS-V15 and had both a normal near point of convergence and normal positive fusional vergence at near were considered “cured.” In the vision therapy/orthoptics group, three of 12 (25.0%) patients achieved these criteria, whereas no patients in the placebo vision therapy/ orthoptics group or in pencil pushups did so. Patients who achieved a decrease in symptoms (21 on the CI Symptom Sur￾vey–V15) and achieved normal values in either the near point of convergence or positive fusional vergence at near were considered “improved.” In the vision therapy/orthoptics group, three of 12 (25%) patients achieved this criteria, whereas two of 13 (15.4%) in the placebo vision therapy/orthoptics group and two of 15 (13.3%) in pencil pushups group did so. DISCUSSION In this first randomized, placebo-controlled, multicenter clini￾cal trial studying the treatment of symptomatic CI in young adults, office-based vision therapy/orthoptics improved the signs associ￾ated with CI. Both the average near point of convergence and the average positive fusional vergence at near improved to roughly normal clinical values, although 58% of the patients in this group were still considered to be symptomatic after 12 weeks of treat￾ment. There were statistically significant but not clinically relevant improvements in both the mean near point of convergence and the mean positive fusional vergence break at near in the pencil pushups and placebo office-based vision therapy/orthoptics groups. In ad￾dition, 80% of those in the pencil pushups treatment group and 69% of those in the placebo vision therapy/orthoptics group were still considered to be symptomatic after 12 weeks of treatment. If we instead consider both symptom level and clinical findings to classify patients as “cured” or “improved,” patients receiving vision therapy/orthoptics again fared better than patients in either of the other two treatment groups. After 12 weeks of treatment, 50% of patients in the vision therapy/orthoptics group were either “cured” (three of 12 or 25%) or “improved” (three of 12 or 25%). In contrast, none of the patients assigned to pencil pushups and placebo vision therapy/orthoptics group were “cured,” and only two of 13 (15%) in the pencil pushups and two of 15 (13%) in the placebo vision therapy/orthoptics group were “improved.” These findings are surprising in light of previous studies demon￾strating a significant decrease in symptoms after orthoptic treatment for CI in adults. Both Cooper23 and Grisham,14 in reviewing the literature, reported that over 90% of patients with CI reported elimi￾nation of their symptoms. Most of the studies reviewed by these au￾thors reported on adult patients with CI. However, these findings were based on papers that were retrospective, uncontrolled and did not TABLE 6. Perception of treatment group assignment versus actual assigned treatment group—week 12 visit Patients assigned to vision therapy/orthoptics Patients believing they were assigned to: Percent reporting specific group Percent pretty sure or very sure of answer Vision therapy/ orthoptics 90.0 100.0 Placebo vision therapy/orthoptics 10.0 0.0 Patients assigned to placebo vision therapy/orthoptics Patients believing they were assigned to: Percent reporting specific group Percent pretty sure or very sure of answer Vision therapy/ orthoptics 75.0 44.4 Placebo vision therapy/orthoptics 25.0 33.3 Convergence Insufficiency in Young Adults—Scheiman et al. E591 Optometry and Vision Science, Vol. 82, No. 7, July 2005

E592 Convergence Insufficiency in Young Adults-Scheiman al. vaid insmensmpoms before andermecompuo eerience more nonvisally relaed ympeos at In these stdies.putients simply repartd their symptoens vebolly to might mimic the visual symptoms texed on the CI Sympenm the doctoe bofone and afecr tment This apprcoch is pmone to in-Survey and thus remain symptomatic cven after treatment.The terpretation or and opcrimener bias. higher meam sures for ptients 19 to 30 ycars of a oompard with Honwever,in on cobort of symptomatic patients with Cl,Coo- those9 to 18 yearofageand the higher cut point fur an asymptom- perused an automated computer prugram to present vergence a位scre on the CISSV-】5'that this may be true stimuli in an A-B cnossover design to sysrematically trear cight We attempted to control for the cffect of the'therapist as a adult patients Pasitive rcinforccmcnt,time of trcatment,and ther- placcboheaue it has boen repored that the enthusiam,car- apy stimuli udr the sm in the togroupsp tht halfof ing,and cumpasion of a therapist may phy a key rolc in treatment the patients reccived vergence therapy,whereas the other half re- outcome.We did this by designing placebo therapy that simu- ceived placebo nonvergence therapy.After end-point criteria were lated bona fide procedures.and training the therapists to behave achieved,the two tmeatment groups were revenod,i.c.thos re- identically for patienes in both the vision therapylorthoptics and oiving vrg therapy reocived plaocbo and vice vers.Thoe placcbo vision therapylorthoptios groups.Webelicve that the data paticnts roxceiving vergence therapy demonstrated a mean 18r in- reported here cnfirms that we were succosful in achieving this crease in positive fusional wergence to aposttreatment mean of 30r objective because 75%of the patients assigned to placebo vision BO and a change in symptom score from moderately uncomfort therapy/orthopics believed they had been ssigned to the vision able to almost symptom-froc.It is srprising that in our slighthy therapy/orthoptics group. larger oohort,we did not achieve a cmparable decras in asthe- This sudy was designed as a pilut study to prepare the CI'T'T popia,especially in light of the fact that various accommodative Study Group for a lrpe-scale randomized clinical trial.As such and vergence treatment procedures were performed. there are a number of limitations that must be considered when One could argue that alnger treament period may have resed interpreting the results of this study.First,the sample size of 46 in addcion changes.After 12 wees of teatment,the mean symp. patients was small,which affects the precisioa of our trearment como the patints in the vison therapylorthoptics group de- effects.Scoond,although the retention rate for this study was ac creasd below 21 ie considered asymptomatic)for the fint time and ceptable and patient loss was not related to treatment asignment. did not appear have recheda placea yet.Perhaps additional m six of46(1)patients were dropped from the study o did not provement would have occurred after moce trearment visits.We strug. complete the 12 weeks of treatment within the window for the gled wich detemmining the approprie length ofreament time when outcome visit.A third potential issue was the 12-weelt trearment we were planning this sudy.Although traditional in-offioe vision period.Perhaps a longer treatment period may have resulted in therapyforthopticsor parients with Cmay require anywhere from12 additional changes in signs and symptcms.Finally,it will be crit to 24 office visitswe sdected the minimum number of visis be ic in fiuture studies to investigate the longtem oucome of any cause we thought it would 1)besufficient length of teacment time for treatment for Cl. adult patients with CI and 2)because we wanted to ninimie the number of treatment seons for those assignd to pbocbo tratment. We were alo concemed that the longer the treament program,the CONCLUSIONS more the potential for retention prohlems with the placebo treatment This fint multioenter,randomizod dlinical trial of the trearment group. of symptomatic Cl in young adults demonstrated that of the three Another issue is what happens to symptons.near point of con- treatment modalities,anly vision therapy/orthoptics was effective vergence,and positive fusional vergence at near over time.The in achieving normal cinical values for boch the near point of con CIII study wis not designed to look at long-term results.This vergence and positive fusional vergence.Parients in the pencil question Deeds to be answered in a prospective,large scal,ran pushups gruup achicved normal values only for poitive fusional domized clinical trial. vergence at near and patients in the placcbo vision therapyfortbop- The results from this study of young adulrs with sympeomatic tics group did not achieve nocmal findings for either the near point Cl are ala different from the results we repored for children with of comvergence or positive fusional vergence at near.Therefore,the symptomatic CI.In the previous study of children with Cl,we effectiveness of vision therapyforthoptics in improving the near found a staristically significant impeovement in boch clinical signs puint of convergence and pusitie fusional cmvergeno valuc at and sympcons using山e same I.2-week vision therapy/o小hop国ic near in adults cannot be explained on the basis of a placcbo effoct. regimen.Pencil pushups treatment ws not found tobe effective in decreasing signs or symptoms in children with Cl.and in fet. Based on the results of this preliminary study.it would appear that pencil pushups,the most popular treatment for Cl.is not effective pencil pushups was no more effective than placebo vision therapy! for achieving clinically significant improvements in symptons or orthoptics.One simple explanation for the treatment differences signs associated with CI in young adults. found berween the chaldren and adules in these rwo studies is that Cl can be more effectively treated in children thn adults.How- ever,previous rerropective research described heres that this my not be tmuc.Becase clinical findings improved in the THE CONVERGENCE INSUFFICIENCY vision therapy/orthopeics group to appeoximaey the same degree TREATMENT TRIAL (CITT)STUDY GROUP in both children and adules.the rwo groups my hve responded CLINICAL SITES differentlly to the CI Symptoen Survey.Pethaps young adules in Lignl in arder of rumber of patieres mnrallad into the study,wich cey, college or in the wark farce send more time rrading or using stae,site name,and numhe of parients in parenthes Psnrael are lid a Optouebry and Viuiau Seimer,Vol K2.Na.Jely5 Copyright American Academy of Optometry.Unauthonzed reproduction of this artcle is prohibited

use a valid instrument to assess symptoms before and after treatment. In these studies, patients simply reported their symptoms verbally to the doctor before and after treatment. This approach is prone to in￾terpretation error and experimenter bias. However, in one cohort of symptomatic patients with CI, Coo￾per15 used an automated computer program to present vergence stimuli in an A–B crossover design to systematically treat eight adult patients. Positive reinforcement, time of treatment, and ther￾apy stimuli used were the same in the two groups except that half of the patients received vergence therapy, whereas the other half re￾ceived placebo nonvergence therapy. After end-point criteria were achieved, the two treatment groups were reversed, i.e., those re￾ceiving vergence therapy received placebo and vice versa. Those patients receiving vergence therapy demonstrated a mean 18r in￾crease in positive fusional vergence to a posttreatment mean of 30r BO and a change in symptom score from moderately uncomfort￾able to almost symptom-free. It is surprising that in our slightly larger cohort, we did not achieve a comparable decrease in asthe￾nopia, especially in light of the fact that various accommodative and vergence treatment procedures were performed. One could argue that a longer treatment period may have resulted in additional changes. After 12 weeks of treatment, the mean symp￾tom score for the patients in the vision therapy/orthoptics group de￾creased below 21 (i.e., considered asymptomatic) for the first time and did not appear to have reached a plateau yet. Perhaps additional im￾provement would have occurred after more treatment visits.We strug￾gled with determining the appropriate length of treatment time when we were planning this study. Although traditional in-office vision therapy/orthopticsfor patients withCI may require anywherefrom 12 to 24 office visits,8,9 we selected the minimum number of visits be￾cause we thought it would 1) be sufficient length of treatment time for adult patients with CI and 2) because we wanted to minimize the number of treatment sessions for those assigned to placebo treatment. We were also concerned that the longer the treatment program, the more the potential for retention problems with the placebo treatment group. Another issue is what happens to symptoms, near point of con￾vergence, and positive fusional vergence at near over time. The CITT study was not designed to look at long-term results. This question needs to be answered in a prospective, large-scale, ran￾domized clinical trial. The results from this study of young adults with symptomatic CI are also different from the results we reported for children with symptomatic CI.18 In the previous study of children with CI, we found a statistically significant improvement in both clinical signs and symptoms using the same 12-week vision therapy/orthoptics regimen. Pencil pushups treatment was not found to be effective in decreasing signs or symptoms in children with CI, and in fact, pencil pushups was no more effective than placebo vision therapy/ orthoptics. One simple explanation for the treatment differences found between the children and adults in these two studies is that CI can be more effectively treated in children than adults. How￾ever, previous retrospective research described here suggests that this may not be true. Because clinical findings improved in the vision therapy/orthoptics group to approximately the same degree in both children and adults, the two groups may have responded differentially to the CI Symptom Survey. Perhaps young adults in college or in the work force spend more time reading or using computers or experience more nonvisually related symptoms that might mimic the visual symptoms tested on the CI Symptom Survey and thus remain symptomatic even after treatment. The higher mean scores for patients 19 to 30 years of age compared with those 9 to 18 years of age18 and the higher cut point for an asymptom￾atic score on the CISS V-1519 suggest that this may be true. We attempted to control for the effect of the “therapist as a placebo”24 because it has been reported that the enthusiasm, car￾ing, and compassion of a therapist may play a key role in treatment outcome.25 We did this by designing placebo therapy that simu￾lated bona fide procedures, and training the therapists to behave identically for patients in both the vision therapy/orthoptics and placebo vision therapy/orthoptics groups. We believe that the data reported here confirms that we were successful in achieving this objective because 75% of the patients assigned to placebo vision therapy/orthoptics believed they had been assigned to the vision therapy/orthoptics group. This study was designed as a pilot study to prepare the CITT Study Group for a large-scale randomized clinical trial. As such, there are a number of limitations that must be considered when interpreting the results of this study. First, the sample size of 46 patients was small, which affects the precision of our treatment effects. Second, although the retention rate for this study was ac￾ceptable and patient loss was not related to treatment assignment, six of 46 (13%) patients were dropped from the study or did not complete the 12 weeks of treatment within the window for the outcome visit. A third potential issue was the 12-week treatment period. Perhaps a longer treatment period may have resulted in additional changes in signs and symptoms. Finally, it will be crit￾ical in future studies to investigate the long-term outcome of any treatment for CI. CONCLUSIONS This first multicenter, randomized clinical trial of the treatment of symptomatic CI in young adults demonstrated that of the three treatment modalities, only vision therapy/orthoptics was effective in achieving normal clinical values for both the near point of con￾vergence and positive fusional vergence. Patients in the pencil pushups group achieved normal values only for positive fusional vergence at near and patients in the placebo vision therapy/orthop￾tics group did not achieve normal findings for either the near point of convergence or positive fusional vergence at near. Therefore, the effectiveness of vision therapy/orthoptics in improving the near point of convergence and positive fusional convergence values at near in adults cannot be explained on the basis of a placebo effect. Based on the results of this preliminary study, it would appear that pencil pushups, the most popular treatment for CI, is not effective for achieving clinically significant improvements in symptoms or signs associated with CI in young adults. THE CONVERGENCE INSUFFICIENCY TREATMENT TRIAL (CITT) STUDY GROUP CLINICAL SITES Listed in order of number of patients enrolled into the study, with city, state, site name, and number of patients in parentheses. Personnel are listed as E592 Convergence Insufficiency in Young Adults—Scheiman et al. Optometry and Vision Science, Vol. 82, No. 7, July 2005