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e therapies oseful, contimity with ththeir mutuar in their (1)ence and ac(4) use of mher these d

recently, thdocument tomized cliniy Group com

s investigatinptomatic CI ism readingitudes less t

e effective thpared the efe-based placapy/orthoptioving both tr study was tion, it was sapy/orthopti

purpose of tactive treatment using pencil push-home reinfooving sympt

sufficiency (disorder1-4 tf symptoms,red vision, dtrating, movs of compreng or perfornts10, 14-23 asm reading gencil push-uherapy techrding the mferences amhthalmic coment by botic CI.24-26

for the trearolled manihe aim of nol interaction) ability to cccommodativmotor learninifferences a

here has beehe effectivecal trial, the

mpleted 2 ping the effecin children. glasses prethan twice than placeboffectiveness cebo vision tics to be mothe signs ana 19% (9 o

suggested tics regimen

this randomtments for CHBPP, hom

-ups (HBCVAorcement (Otoms and si

CI) is a comthat is often, including ediplopia, slevement of phension afteming close are commonlglasses and ps (HBPP) aniques, officost effectiveong treatmemmunity suth ophthalm

atment of sypulation of tormalizing tns.27 The varcontrol and mve demand)ng theory anffect the ou

en a scarcityeness of treae Convergenilot studies tctiveness of 28-29 In the

escribed accthe near phoo reading gla

of HBPP, oftherapy/ort

ore effectivend symptomof 47) loss that a more should have

ized clinicalCI. We come-based comAT+), officeOBVAT), andgns associa

mmon n associatedeyestrain, epiness,

print while er short activities.5-1

ly prescribedactive treat

alone, homece-based vise treatment ents in time

uggest that mologists and

ymptomatic target blur,he accommrious active manipulate ), (2) dosagnd patient fetcome of tre

y of rigorouatments for nce Insufficithat were ppassive andtrial that ev

cording to Soria),30 prismasses.28 Theffice-based vhoptics foun

e than pencims associate

o follow-up intensive hoe been inclu

trial was topared the efmputer verg-based verg

d office-baseated with sy

13 d, includingtment, suche-based thesion therapyis lacking a

e and cost. RHBPP is thed optometri

CI typicallyvergence dodative andtreatment astimulus pa

ge, (3) modeeedback. It eatment.

sly performCI. In prepaency Treatmlacebo-contd active trea

valuated theheard's critem glasses we other randvision therand office-bal push-ups od with CI.29

before treaome-based uded as a tr

o further evaffectivenessgence/accomgence/accomed placebo tmptomatic C

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passive treh as home-brapy using py, and orthoand there arRecent stud most commists for youn

y involve theemand, and

d vergence sapproaches arameters (ee of adminisis unknown

med scientificaration for oment Trial (Ctrolled, randatments for e effectiveneerion (conve

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9 A limitationtment compvision

reatment arm

aluate the cs of 12 weekmmodative tmmodative ttherapy (OBCI in childre

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valent, or 1.oplegic refrap to 1.25 D.t least 2 wethe eligibilitormed with a

MINATION

bility testingsymptomatiy at distancnear, NPC, aergence andmmodative

tenets of thstudy. The inrticipating ceormed consequently refent gave writt assented tnsent procenation follownt and randbility and Acoversight wamittee.

CTION

criteria for tnear of at lenvergence (r (PFV) (conthe near phoI Symptom ic CI often hmptomatic Cstudy. Howeopters (D) winsufficiencyg of eligibili

ection was cant changened as 1.50er of astigm.50 D or grection). For h. For myopiaeeks, eligibily criteria. Tappropriate

N PROCEDU

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ce and near,and positived divergenceamplitude,

he Declaratinstitutional enters approent forms. Terred to as ptten informeo participat

ess for perfowed by a secomization occountabilityas provided

the trial waseast 4 prismNPC) break

nvergence aoria]30 or mSurvey (CIShave an assCI associateever, childrewere excludy may indicaty and exclu

prescribed fe in refractiv D or greateatism, 0.75 eater of anishyperopes, ta, full correcity testing whus, the CISrefractive c

URES

dministratioOther eligibi a sensorim

e and negatie amplitudemonocular

on of Helsinreview oved the The parent oparent) of ed consent ion. There rming an cond consenof eligible pay Act authorby an indep

s being agedm diopters (

( 6 cm), implitudes) inimum PFVSS) score of ociated accod with acco

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for patients ve correctioner of hyperoD or greate

sometropia ithe investigction was rewas repeatedSS and eligicorrection in

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d 9 to 17 ye) greater

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V of 15 bf 16 or greatommodative

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if they had n. A significopia, 0.50 Der of anisomin any meridgator could required. Afted to determibility testinn place.

SS to identicluded bestnation (covevergence aereoacuity, ative facility

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the trial. Hes obtained frta and safety

ears and havthan at far,positive fusSheard's critbase-out bluter. Becausee insufficieninsufficienc

mmodative y of their . The eTable

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achieve clear vision while alternately viewing 20/30 print through +2 D and –2 Dlenses), a cycloplegic refraction, and an ocular health evaluation. Convergence Insufficiency Treatment Trial–trained and –certified ophthalmologists or optometrists performed all testing using a previously described standardized protocol.34 Eligible patients who consented to participate were enrolled in the study, and the measures taken at their eligibility examination were used as the study baseline measures.

RANDOMIZATION

Using a permuted block design, we randomly assigned eligible patients who consented to participate with equal probability to HBPP, HBCVAT+, OBVAT, or OBPT. Randomization was achieved using a secure Web site created and managed by the data coordinating center. To ensure approximately equal numbers of patients in

each treatment arm by site, randomization was stratified by clinical site.

TREATMENT PROTOCOLS

The therapy regimens each lasted 12 weeks. Patients were taught their assigned therapy procedures by CITT-trained and -certified therapists. Therapists were either optometrists, vision therapists, or orthoptists with at least 1 year of experience; most optometrists were residency-trained. Patients were required to demonstrate

their understanding and ability to perform home therapy procedures in the office before the therapies were prescribed for home. Instructional handouts were also provided for the home treatment procedures. Patients in all groups maintained a home therapy log and recorded their performances for each home therapy session. Monthly office visits were scheduled for those assigned to the 2 home-based therapy groups. At these visits, the therapists answered questions, reviewed home therapy procedures, and estimated adherence (compliance). In addition, the therapist contacted the patients by telephone on a weekly basis, during which time

the home therapy procedures and home logs were reviewed and attempts were made to motivate the patients to adhere to treatment. Those assigned to office-based therapy groups were scheduled for weekly office therapy visits.

All treatments included time for instruction, feedback, review of the home log, and discussion about adherence. For the office-based groups, this all occurred during the weekly office visits. For the home-based groups, these interactions occurred every 4 weeks in the office and weekly via a telephone call with the therapist. The total treatment time for each group included the time spent in therapy at home or in the office plus the contact with the therapist via the weekly phone calls (for the home-based therapy groups).

HOME-BASED PENCIL PUSH-UPS

The pencil push-ups procedure involved using a pencil with 20/60 reduced Snellen letters and a white index card placed in the background to provide a suppression check by using physiological diplopia awareness. The goal of the procedure was to move the pencil to within 2 to 3 cm of the brow, just above the nose on each push-up while trying to keep the target single and clear. Patients were instructed to perform the pencil push-ups procedure 15 minutes per day, 5 days per week. They maintained home therapy logs, recording the closest distance that they could maintain fusion after each 5 minutes of therapy.

HOME-BASED COMPUTER VERGENCE/ACCOMMODATIVE THERAPY AND PENCIL PUSH-UPS

Patients in this group were taught to perform the pencil push-up procedure as well as procedures on the Home Therapy System/Computerized Vergence System (HTS/CVS) computer software system (Computer Orthoptics, Gold Canyon, Arizona). Using this program, they performed fusional vergence and accommodative therapy procedures, including vergence base-in, vergence base-out, autoslide vergence, and jump ductions vergence programs using random-dot stereopsis

targets. The accommodative rock program was used for accommodative therapy. Much like a clinician would do at each follow-up visit, this computer program automatically modified the therapy program after each session based on the patient's performance. Patients were instructed to do pencil push-ups 5 minutes per day, 5 days per week, and the HTS software program for 15 minutes per day, 5 days per week, and to save their data on a disk provided by the study and to bring the disk to each follow-up visit.

OFFICE-BASED VERGENCE/ACCOMMODATIVE THERAPY WITH HOME REINFORCEMENT

The OBVAT group received a weekly 60-minute in-office therapy visit with additional prescribed procedures to be performed at home for 15 minutes a day, 5 days per week. The therapy procedures are described in detail elsewhere29 and those performed during the weekly OBVAT sessions are shown in the eFigure. At each

office-based therapy session, the patient performed 4 to 5 procedures with constant supervision and guidance from the therapist. There were no diagnostic tests performed during these sessions. The therapist followed a detailed and specific protocol from the CITT manual of procedures (http://optometry.osu.edu/research/CITT/4363.cfm); this document describes each procedure, amount of time procedure was performed, expected performance, and criteria for ending the procedure and advancing to a more difficult level.

OFFICE-BASED PLACEBO THERAPY

Patients in the OBPT group received therapy during a weekly 60-minute office visit and were prescribed procedures to be performed at home for 15 minutes per day, 5 days per week. The placebo therapy program consisted of 16 in-office therapy procedures and 4 home therapy procedures, which were designed to look like real vergence/accommodative therapy procedures yet not to stimulate vergence, accommodation, or fine saccadic eye movement skills beyond normal daily visual activities. The therapist followed a detailed protocol from the CITT manual of procedures. Five procedures were performed during each office therapy visit and 2 procedures were assigned for home therapy each week. Placebo procedures included traditional vergence/accommodative therapy procedures modified to be monocular rather than binocular; binocular procedures performed at 0 vergence disparity; and testing procedures that did not require significant demand on the vergence, accommodative, or fine saccadic eye movement systems. For example, in 1 placebo procedure, the patient wore the appropriate filter glasses and performed vergence therapy at 0 vergence demand on the Computer Orthopter (Computer Orthoptics). Some procedures were designed to have increasing levels of difficulty. As in real therapy, patients frequently wore filter glasses and were told that the

glasses ensured that both eyes were being used together. Objectives and goals

were established for each placebo procedure to simulate real therapy. For motivational purposes, the therapist told the patient the objective of each procedure before beginning the technique.

MASKING OF THERAPISTS AND PATIENTS

Because experienced therapists provided the treatments, it was not feasible to mask them to patients' assigned treatment. However, each therapist followed a well-defined protocol for all treatments and was instructed to interact in an identical fashion with all patients. Although patients were obviously aware of whether they were assigned to office- or home-based therapy, those receiving office-based treatment were masked regarding whether they were assigned to vergence/accommodative or placebo therapy.

To determine the effectiveness of masking, patients assigned to either of the 2 office-based treatments were asked at the completion of their treatment whether they thought they were randomized into the active or placebo treatment. To assess examiner masking, examiners were asked if they thought they could identify the patient's treatment assignment at the completion of each masked examination. In addition, at the completion of the 12-week outcome examination, examiners were asked to guess the patient's group assignment and to report a level of confidence in the response.

FOLLOW-UP EXAMINATIONS

Protocol-specified follow-up visits were conducted after 4 and 8 weeks of treatment. The primary outcome assessment was made at the visit following the 12th week of treatment. At these follow-up visits, an examiner who was masked to the patient's

treatment group administered the CISS and a sensorimotor examination that included cover testing at distance and near, NPC, PFV, accommodative amplitude, and accommodative facility testing. After the clinical testing was completed, the CISS was readministered.

TREATMENT ADHERENCE DATA

To assess adherence with home-based therapy, at each masked examination the therapist was asked, "What percent (0%, 1%-24%, 25%-49%, 50%-74%, 75%-99%, or 100%) of the time do you feel the patient adhered to the home protocol?" The therapists' estimate was based on a review of the home log, electronic data from the computer therapy program, and a discussion with the patient about home therapy. Thus, this estimate was primarily based on patient reports. The response options of 0%, 1% to 24%, 25% to 49%, and 50% to 74% were combined into 1 category (0%-74%) for data analysis because only 16% of patients were categorized into the response options below 75%.

MAINTENANCE THERAPY

Patients who demonstrated sufficient improvement on the CISS at the 12-week outcome visit were considered asymptomatic (CISS score <16) and were prescribed maintenance therapy of 15 minutes per week using home therapy procedures specific to the patient's assigned treatment group. Patients not demonstrating

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TISTICAL A

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ANALYSIS

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s were perfoalyses followCISS score sit were usehe base-out

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sed to compving successoup compari

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were perforh 90% pow

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083 (0.05/6)

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a 10% loss t

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ed for analysto blur mea

up by 3-perused to com-week visitsate estimateseline value l pilot data sIn addition,

examined as cular outcousion in theed a significent for multt = 0.05. struct 95%

pare the percful or improsons of the

improve bofication that e 12-week en the CISS, heard's criterease in thet in NPC of Patients whome were co

rmed using er. For a givned from thr multiple coarisons]), th).

ll hypothesition differenPFV. These

ability of eacthe requiredto follow-up

g SAS, versiention-to-tremeasures ofses. Positiveasure if pres

riod repeatempare the tres maximizese of the meaof the outcoshowed a stall clinical apotential co

me measuree final ANCOcant group eiple pairwiseThe mean sconfidence

centage of poved outcompercentage

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PASS 2000ven outcomhe CITT pilotomparisons

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S Institute, e. The meanNPC and PFVergence at nwise, base-o

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up).

Figure 2.randomizeConvergeTreatmenindicates computer vergence/therapy aHBPP, hompush-up toffice-baswith homeand OBVAvergence/therapy wreinforcemvisit.

d by therape was 67.3%T group, andrences in esparisons for

ted by TherProtocol at

. Flowchart ed, clinical nce Insuffict Trial. HBChome-based

/accommodnd pencil pume-based ptherapy; OBsed placebo e reinforcemAT, office-ba/accommod

with home ment. *One

pists as comp% in the HBd 91.4% in stimated adsymptom sc

rapist as CoLeast 75%

of the

ciency CVAT+ d

ative ush-ups;

pencil BPT,

therapy ment; ased ative

missed

pliant with BCVAT+ the OBVAT herence did core, NPC,

mpliant of the

Eightassigto thpatieexamthe erespoassigExamassigcorreassigconfi

PRIM

Figurthe 4outcolower(Tabl6.8 p3.4-1and Hdiffer11.9;differP .

ty-five percegned to verge active the

ents' group aminer felt thaexaminers reonded that hgned to HBPPminers, whengnment onlyect vs incorrgnment and dence interv

MARY OUTC

re 3 displays4 treatment ome examinr mean symle 3). The mpoints lower 10.3; P < .0HBPP grouprence in me; P < .001),rences were38 for all).

Vie

ent of the pagence/accomerapy groupassignment at he could esponded thhe/she was P, and 21%n asked to g

y 34% of therect, P < .00the examinval, 0.04-0.

COME MEA

s the cumulgroups at b

nation, patieptom level c

mean CISS sthan that in

001). A meas (95% conan symptom, observed be observed a


[in a new win

atients assigmmodative t. None of that the 4- oridentify the

hat their patassigned to said their pguess, weree time, whic01). There wer's guess o20).

ASURE

ative distribbaseline andents assignecompared wscore at 12 wn patients an differencefidence inte

m level was between theamong the H

sion (48K): dow] ndow]

gned to plactherapy beliee examiners

r 8-week mae group assigtient was aso HBCVAT+, patient was e correct in ich is less thawas low agreof assigned

bution plots d after 12 wed to the OB

with patientsweeks in passigned to O

e of 7.9 poinerval, 4.4-118.4 points (

e OBVAT andHBPP, HBCV

cebo therapeved that ths felt that thasked examgnment at o

ssigned to th 21% said tassigned toidentifying tan is expecteement betwtreatment g

of the meaneeks of trea

BVAT group s in the 3 otatients in theOBPT (95% nts was foun1.4; P < .00(95% confidd HBCVAT+ VAT+, and O

Figure 3.distributioInsufficienSurvey scduring theexaminatimasked e12. HBCVhome-basvergence/therapy aHBPP, hompush-up toffice-baswith homeand OBVAvergence/therapy w

py and 93% hey had beehey could id

minations, anoutcome. Onhe OBVAT gtheir patiento the OBPT gthe patient'sted by chancween the acgroup ( = 0

n symptom atment. At treported a sther treatmee OBVAT groconfidence

nd between 01). The largdence interv

groups. NoOBPT groups

. Cumulativeon of Convency Symptocores collecte eligibility ion and at t

examination VAT+ indicatsed compute/accommodnd pencil pume-based ptherapy; OBsed placebo e reinforcemAT, office-ba/accommod

with home

of those en assigned dentify the nd only 1 ne-third of roup, 24% t was group. s group ce (ie, 50%

ctual group 0.11, 95%

level for he 12-weeksignificantlyent groups oup was interval, the OBVAT

gest val, 4.9-o significants (pairwise

e rgence m ted

he at week

tes er ative ush-ups;

pencil BPT,


%

k y

As seasymat thwith P = .consibased

We asymptreatchanwouldscorethe OobseHBCVamon

SECO

NPC



een in Tablemptomatic (ie outcome ethe other tr004). Thereidered asymd groups (p



also used anptom score oment if impce that patid be classifiee was withinOBVAT grourved in any VAT+, P < .ng the latter

ONDARY O

Break

[as a PowerPoi


e 4, the perce, CISS scoexaminationeatment groe was no sigmptomatic oairwise P >


n alternate dof less thanrovement wents with CIed as achiev

n the normap met this cof the other001; 35% ir 3 treatmen

UTCOME M

nt slide]

Table 3. Each Out

centage of pore <16) or in) was signifoups (HBPPgnificant diffr improved

.60 for all).

Table 4. Converge

definition of 16 were on

was 10 or mISS scores tving successl variability

criterion, whr treatment n OBPT, P =nt groups (p

MEASURES

Means and tcome by Tr

patients in eimproved (ieficantly high, P = .013; ference in thbetween the

Improvemeence Insuffic

success in wnly considerore points (that just mesful treatmeof the surve

hich was signgroups (38

= .001); thepairwise P >

reinforcem

95% Confidreatment Gr

each group we, change inher in the OHBCVAT+,

he percentage OBPT grou

ent in Signs ciency by T

which patiered to have hTable 4). Th

et the eligibient when they. Sixty-sixnificantly gr

8% in HBPP,ere were no > .50 for all)

ment.

dence Intervroup and Tim

who were con score of BVAT groupP < .001; Oge of patienup and the 2

and Symptoherapy Grou

nts who achhad successhis eliminateility criterion

he change inx percent ofreater than , P = .003; 3statistical d

).

vals for me

onsidered 10 points

p compared OBPT, nts 2 home-

oms of up

hieved a sful ed the n ( 16) the CISS f patients inthat 33% in differences

n

Figurtreatthe motherhome(pairwthe 2

The pof 4OBVAHBCVwith with (P = home

We aachieimprothe OfoundHBPPdiffer

re 4 displaysment group

mean NPC wr 3 groups (e-based growise P .0

2 home-base

Vie

percentage 4 cm) NPC aAT group coVAT+, P = .a normal orthe OBPT g.06 and .07

e-based gro

also used aneved a normovement wa

OBVAT groupd in any of tP, P = .002;rence betwe

s the cumulps at baselinwas significapairwise P

oups measur1 for all), thed therapy g



of patients at the 12-wempared wit006; OBPT, r improved Nroup; howe

7, respectiveoups (P = .9

n alternate dmal NPC weras greater thp achieved tthe other tre and 54% in

een the HBC

ative distribne and after ntly improve .005 for a

red significahere were nogroups (P =


who had noeek outcomeh the other P < .001) (

NPC in bothver, the diffely). There w3).

definition of e only conshan 4 cm (Tthis criterioneatment gron OBPT grouCVAT+ and t

bution plots 12 weeks o

ed in the OBll) (Table 3)

antly closer to statisticall

= .33).

ormal (breake examinatitreatment g

(Table 4). T the HBPP a

ference was was no sign

successful tidered to ha

Table 4). Eign, a significaoups (71% iup, P < .001the OBPT gr

of the meanof treatmentBVAT group). While thethan that ofy significan

Figure 4.distributioconvergenduring theexaminatimasked e12. HBCVhome-basvergence/therapy aHBPP, hompush-up toffice-baswith homeand OBVAvergence/therapy wreinforcem

k <6 cm) orion was signgroups (HBPhere were s

and HBCVAT not statistiificant diffe

treatment inave had a sughty-seven pantly highern HBCVAT+1). There waroups (P = .

n NPC breakt. At the out compared

e mean NPC f the OBPT gt difference

. Cumulativeon of near pnce data cole eligibility ion and at t

examination VAT+ indicatsed compute/accommodnd pencil pume-based ptherapy; OBsed placebo e reinforcemAT, office-ba/accommod

with home ment.

r improved (nificantly grePP, P = .008slightly moreT+ groups cocally significrence betwe

n which patiuccessful trepercent of pr percentage+, P = .023;as also a sig032); no dif

k for the 4 tcome visit, with the of both

group s between

e point of llected

he at week


pencil BPT,


(decrease eater in the 8; e patients ompared cant een the 2

ients who eatment if patients in e than that ; 64% in gnificant fferences

were(P = wouldbase

PFV

FigurtreatexamgreatHBCVOBPTand O

As seoutcootherThereimpro

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found betw.20) groupsd be consideline, which i

at Near

re 5 displaysment group

mination, theter than all oVAT+ groupT (P = .008)OBPT group

Vie

een in Tableome examinr treatment e were no soved PFV in

ith CISS scoh patients wessful treatm

ween the HBs. This consered to havemproves to

s the cumulps at baseline mean PFV other group was signific) groups. Ths (P = .57).



e 4, the percnation was sgroups (HBignificant di the latter 3

ore and NPCwho achievement outcom

PP group anervative este had clinica 3.5 cm).

ative distribne and after

for patientss (pairwise cantly bette

here was no .


centage of psignificantly PP, P = .00fferences in

3 treatment

C break, an d a normal me if improv

nd either thetimate woulally successf

bution plots 12 weeks o

s in the OBVP < .001 fo

er (higher) tsignificant

patients withhigher in th2; HBCVAT+ the percengroups (pai

alternate dePFV were on

vement was

e HBCVAT+d not includful treatmen

of the meanof treatmentVAT group wor all). The mhan in the Hdifference in

Figure 5.distributiofusional vcollected dexaminatimasked e12. HBCVhome-basvergence/therapy aHBPP, hompush-up toffice-baswith homeOBVAT, overgence/therapy wreinforcemdiopter.

h normal orhe OBVAT gr+, P = .007

ntage of patiirwise P > .

efinition of snly consider greater tha

+ (P = .37) ode some patnt (eg, a 7 c

n PFV at neat. At the outwas significamean PFV inHBPP (P = .n response

. Cumulativeon of positivvergence datduring the eion and at t

examination VAT+ indicatsed compute/accommodnd pencil pume-based ptherapy; OBsed placebo e reinforcemffice-based /accommod

with home ment; and

improved Proup compa

7; OBPT, P <ients with n10 for all).

success wasred to have an 10 (Ta

or OBPTients who cm NPC at

ar for the 4 tcome antly n the 037) and in the HBPP

e ve ta eligibility he at week


pencil BPT,

therapy ment;

ative

, prism

PFV at the ared with all< .001). ormal or

s used in had a ble 4).

P

Sevesignifin theOBPTHBCVweresomenear

Succ

UsingPFV, outcogroupgrouppatie(33%class

Seco

Previimproand 2respeachiegroupcompcomp

Atte

Childhighetheregroupmeanbetwbetw

ADV

Six aand fto th

COM

nty-three peficantly highe HBCVAT+T group, P <VAT+ and O detected (Pe patients wwith a PFV

cessful, Im

g the compothe proport

ome in the Ops (P < .002p (73%) ha

ents in the H%), and just

ified.

ondary Mea

ous studiesovements o22% of patiectively, acheved both a p compared parison). Noparison).

ntion-Defic

ren with paer on the CIe were slightps at baselinn treatmenteen ADHD aeen ADHD,

ERSE EVEN

dverse evenfurther evale study trea

MENT

ercent of paher percenta group, P =

< .001). TheOBPT groupsP > .10 for a

who would beat near of 1

proved, an

osite outcomtion of patieOBVAT grou2 for all). Wd either suc

HBPP group more than

asures Com

have assesccurred in bents in the hieved both normal NPCwith the ot

o other grou

cit/Hypera

rent-reporteSS at baselt differencesne. Howevedifferences

and treatmetreatment,

NTS

nts that incluations deteatment.

atients in theage than tha .02; 40% i

ere was alsos (P = .007)all). Again, te considered16 at base

nd Nonresp

me classificants found to

up was signihile nearly t

ccessful or im(43%), oneone-third in

mbined

ssed treatmeboth NPC anOBVAT, HBPa normal N

C and a normher treatmep difference

activity Dis

ed attentionine than chs in the distr, ADHD was among theent (P = .93and time an

uded eyes oermined tha

e OBVAT grat in any of n the HBPP a significan; however, this conservd clinically seline, which

ponder Crit

ation, which o have had ficantly greathree-quartmproved ou

e-third of then the placeb

ent effectivend PFV. SevePP, HBCVATPC and PFV

mal PFV wasent groups (es were sign

sorder

n-deficit/hypildren withoribution of ts not a conf

e groups. Th3). We examnd found no

or vision weat none of th

roup achievethe other trgroup, P<

nt differenceno other sigvative estimsuccessful (eimproves t

teria

combines ssuccessful tater than thers of patie

utcomes, lese patients ino group (35

eness by eventy-three pT+, and OBP. The perces significant(P < .001 fonificant (P >

peractivity dut parent-rethese childrfounder and

here was alsmined the 3-

significant

ere reportedhe events w

ed this critereatment gr.001; and 2e between thgnificant diff

mate would neg, 10 exo 25 ).

symptoms, Ntreatment ohat in any ofnts in the Oss than half n the HBCVA5%) were si

valuating whpercent, 40%PT groups, ntage of patly higher inor each pairw .11 for eac

disorder (ADeported ADHen among td did not affso no interacway interaceffect (P =

d. All were uwere serious

rion, a roups (52% 26% in the he ferences not include

xophoria at

NPC, and r improved f the other

OBVAT

the AT+ group milarly

hether %, 37%,

tients who the OBVATwise ch pairwise

DHD) scoredHD, and treatment fect the ction ction .26).

nexpected or related

T

d

We ctherasympvergereinfoHBPPsympsympthe 2no m

We efrom outcosympmeaspropowhenof all

The fwas dinto ctreatBasestudyno grCISSvariathe C

In thpointrangetreatUsingmediet al3meancan bclinicpointon eftreatissue

The sdifferimproOBVAHBCV

ompared thapy approacptomatic CI.ence/accomorcement wP, HBCVAT+ptoms and cptomatic CI.2 home-base

more effectiv

established 4this study:

ome, (2) theptom score osures, NPC, ortion of patn using the c 3 outcome

first criteriondifficult to eclinical pracment regimd on the groy,29 the CITTroup mean d score was bility in CIS

CITT Study G

e present stts on the CIed from 7 toment groupg Cohen’s37 um, 0.8 is l

38 contend thningful diffebe disregardcally meanints change beffect size, thment effect

e.

second criterences amonoved symptAT met this VAT+, and 4

he effectivenches in 221 c. Office-base

mmodative thas significan

+, and OBPTlinical signs. Although sed therapiesve in improv

4 criteria, a (1) the sco

e proportionon the CISSand PFV (cotients classicomposite omeasures).

n, the treatmestablish a ptice, and, coens that indoup mean dT was desigdifferences i10 points. T

SS scores obGroup, trans

tudy, we didSS. Insteado 8.5 pointsps. This tranguidelines farge), the ghat an effecrence that i

ded. Thus, gngful, thoughetween grouhe 10-point . Further stu

erion used tong treatmenom level oncriterion, in

43% assigne

ness of 3 actchildren wited herapy with ntly more ef

T in improvins associated ymptoms ds, these treaving sympto

priori, to deore differencn of childrenS at outcomeonvergence ified as havioutcome clas.

ment grouppriori. Our suonsequentlydicated clinidifferences foned to haveif the true pThis differenbtained fromslates into a

d not find a , we found

s between thslates to anfor interpretgroup differect size of 0.5s scientifica

group differeh they are leups. Lookingdifference wudy and refi

o assess clinnt groups inn the CISS. A contrast toed to OBPT.

tive vision h

home ffective thanng both the with id improve iatments werms than off

etermine thces on the C who achieve, (3) the champlitudes

ing had succssification (c

difference urvey instru

y, the magncal relevancound for the

e 90% powepopulation dnce of 10 pom 3 separatean effect size

difference istatistically

he OBVAT gr effect size tation of effeences we fo5 is a conseally supportaences observess than theg retrospectwas a signifiinement of t

nical relevan patients' aAfter treatm

o 47% assigChanging t

n

in re fice-based p

e clinical relISS betweeved a normahange in secs) at outcomcessful or imcombining t

in the CISSument had nitude of thece had not be CISS in ouer to reject tifference be

oints, along we randomizee of greater

in group mesignificant group and eathat rangesect size (0.2und are conrvative estimable and unlved in this se a priori estively and recant overesthe CISS wi

nce was whebility to ach

ment, 73% oned to HBPthe criterion

Jum • Top


lacebo thera

levance of ten treatmenal or improvcondary out

me, and (4) tmproved outthe treatme

score at ounot been ince difference been establiur previous the null hypetween grouwith data on

ed trials conr than 1 SD.

eans of 10 ogroup differach of the ots from 0.77 2 is small, 0nsidered largmate of a cllikely to be study are costimate of a eviewing thestimate of thill help clarif

ether there ieve a norm

of patients aP, 39% assi

n to require t

mp to Secti

oduction

hods

ults

mmentclusions

hor information

erences

apy.

the data t groups at

ved tcome

the tcomes nt effects

utcome, corporated between 2

shed. pilot

pothesis of ups in the n the ducted by .

r more rences that ther 3 to 0.94 SD.

0.5 is ge. Sloan linically

one that onsidered 10 or more

e literature he potentialfy the

were mal or assigned to igned to that

on

.

e

patients achieved both a score of less than 16 and a change of 10 or more points on the CISS resulted in lower success rates for all groups, but the differences among treatment groups remained the same.

The third criterion used was an evaluation of the secondary outcome measures, NPC and PFV (convergence amplitudes), as they are often used clinically to determine treatment success for CI. The proportion of patients who achieved a clinically normal level for both measures was 73% in the OBVAT group compared with no more than 40% in each of the other 3 treatment groups.

The fourth a priori criterion for determining clinical significance was the proportion of patients classified as having successful or improved outcomes when using the composite outcome classification (combining the treatment effects of all 3 outcomes). A significantly higher proportion of children assigned to OBVAT (73%) compared with the 3 other treatment groups was classified as having successful treatment or improved outcome. No significant differences were observed between the 2 home-based groups and the placebo therapy group. Thus, based on the analysis of all 4 a priori criteria, we conclude that there are both statistically significant and clinically meaningful differences between the groups.

The results of this large, randomized clinical trial are similar to those from the only previous randomized trial of vision therapy/orthoptics for CI in children29 in which 3 treatment groups were studied: HBPP, office-based vision therapy/orthoptics, and OBPT. In that pilot study, only the OBVAT group experienced a significant

improvement in symptoms, NPC, and PFV.

The current study was not designed to show the maximal possible improvement with treatment. Longer treatment may have resulted in additional changes in signs and symptoms. Office-based vergence/accommodative therapy programs for CI often include 12 to 24 office visits.19-21 Our 12-week treatment program was based on the assumption that this represented the maximum length of time that a symptomatic patient who was not improving would stay on the assigned treatment. Because our 12-week treatment program is at the low end of the range of time recommended for office-based CI therapy, it is possible that OBVAT might have been effective in more patients had the treatment program been longer. Likewise, a longer treatment program may have resulted in additional improvements by those

assigned to the home-based treatment groups. It is also possible that using more home-based therapy procedures or prescribing longer periods of daily home-based therapy may have produced different results. Answers to these questions will have to await further study.

While a placebo effect could be associated with any of the 4 treatments owing to the patient's expectation that the treatment would be effective, office-based therapy might be more susceptible to this effect owing to the enthusiasm, caring, and compassion of a therapist who spends 60 minutes per week with the patient.39

However, this is the second randomized trial of OBVAT that was designed to control for the effect of the therapist as a placebo40; placebo therapy was designed to simulate bona fide therapy procedures and therapists were trained to behave identically for patients in both of the office-based therapy groups. The data reportedherein confirm that we were successful in achieving this objective, as 85% of the patients assigned to OBPT believed they had been assigned to the actual OBVAT group. This compares well with our previous pilot study in which 90% of the

patients assigned to placebo therapy believed they had been assigned to actual therapy.29 A no treatment group was not included; therefore, it is not known whether any improvements were due to regression to the mean or natural history of the disease. However, this should have affected all treatment groups similarly because there were no statistically significant or clinically relevant differences in any primary or secondary outcome measure among the treatment groups at baseline. Therefore, the observed differences in effectiveness between the OBVAT and placebo therapy groups are most likely attributable to treatment effect.

The OBVAT used in this study represents a typical approach used in clinical practice.21 We conclude that this specific therapy protocol was successful in this study and should be applicable to children with similar clinical findings. A better understanding of which procedures were most effective will require additional research.

While this study was not designed to determine which factors within a particular group contributed to the outcome, the procedures that comprise the OBVAT provide therapists with the greatest ability to control and manipulate stimulus parameters (eg, vergence amplitude and accommodative demand) and to incorporate motor

learning theory (eg, modeling and demonstration, transfer of training, patient feedback). The weekly visits with the therapist during OBVAT also permit the inclusion of a variety of procedures that stress convergence and accommodative abilities not typically addressed in home therapy programs. There were also differences among the treatment groups in time spent performing therapy and interacting with the therapist. The 2 office-based groups had a mean prescribed therapy time of 135 minutes per week; the HBCVAT+ group averaged 115 minutes; and the HBPP group averaged 90 minutes, which included weekly telephone calls with the therapist. However, this study was not designed to equalize time spent

performing therapy and/or interacting with a therapist; rather, it was designed as an effectiveness study to evaluate 3 clinical treatments typically provided in clinical practice. It is possible that the difference in treatment effect found in this study

could be related to the OBVAT group having been prescribed more minutes of therapy per day than the home-based groups. However, having a patient perform a greater amount of daily home-based therapy, particularly pencil push-ups, is likely impractical.

There are limited data in the literature that suggest there is a relationship between CI and ADHD.41-42 Although we asked parents whether their child had ADHD (ie, parental report), this study was not designed to assess this relationship and was not powered for such subgroup analyses, nor was the diagnosis of ADHD definitive. However, investigation of this possible association is of interest and merits additional research.

We could not identify any other sources of bias or confounding factors to explain our findings. Accounting for slight differences in the distribution of baseline factors between groups in the analyses did not alter the interpretation of the results. The

follow-up visit rate was excellent and almost identical in all 4 groups. The investigators performing the 4-, 8-, and 12-week examinations were masked to the treatment group, and the patients in the 2 office-based treatment groups were effectively masked as well. We did have slight differences in adherence among the

groups, however, and accounting for these differences in estimated adherence did not affect the results of the treatment group comparisons for the CISS score, NPC,

or PF

Whenrecogagedsuggtheraof thenorm

With in thiwith calledofficeeffecweekresulphonwere

It is eits sipatie(4 vistreatis wo

Theretime.betwbasedthey have chaneffecenconot kcan bof thetherasustatreatcond

CON

FV. The plac

n translatinggnize that th 9 to 17 yeaested by ou

apy/orthoptie treatment

malization of

regards to is study for considerabld on a weeke visits evertive if presc

kly telephonts of the CITe calls, prov classified a

easy to undmplicity and

ents in a shosits for homment). Whi

orthwhile to

e are a num. It is possibeen the thed treatmentwere depena placebo h

ges found int. It is possiurage adher

know which be modified e synergisticapist interacained over tment must ucting.

CLUSIONS

ebo effect w

g these studhey can onlyars. Adults wr pilot studyics we used,ts we studieor improve

home-basedthe HBPP gy closer follo

kly basis by ry fourth wecribed accore calls fromTT pilot studvide some ss having su

erstand thed cost-effectort time and

me-based trele our studyexplore in f

mber of interble that therrapist and tt groups' resndent on pathome-basedn the 2 homible that diffrence wouldprocedures to make it mc role of thection. It is aime. Therefawait the re

S

was account

dy results iny be appliedwith symptoy.43 Our find, OBVAT wit

ed in this triaement in sym

d therapy, iroup were dow-up than a therapist,

eek. It is posding to usua a therapistdy, in whichsupport for tccessful or

e clinical poptiveness. Borequire few

eatments coy was not defuture resea

resting clinicre may be pthe patient tsults differetient-therapd therapy gr

me-based groferent protod affect the were most

more effectie active homlso not knowfore, a conclesults of the

ed for by in

nto clinical pd to childrenomatic CI mdings indicatth home reial, with aboumptoms and

t is importaderived from

is typical in, completedssible that thal clinical prt and often hh the HBPP gthis hypotheimproved o

pularity of hoth HBPP anwer follow-uompared witesigned to crch.

cal questionpsychologicathat could afntially (if thpist contact roup and thuoups are duocols that moutcomes. Feffective or ive. This inc

me treatmenwn whether lusion aboute 12-month

corporating

practice, it isn with symptay respond te that the snforcementut 75% of p

d signs withi

ant to note tm a therapy n clinical prad a home loghis treatmeractice, whichas less freqgroup did noesis, as noneutcomes.29

home-basedd HBCVAT+p visits thanth 12 visits fonduct a co

ns that cannal effects froffect the off

hese effects time). In thus, do not ke to a real oore closely For the OBVr whether thcludes undent componen

the treatmet the long-tefollow-up st

Jum • Top

g the OBPT g

s important tomatic CI wdifferently,

specific form, is the mos

patients achin 12 weeks

hat the dataprogram de

actice. Patieg, and returnt would bech does not quent followot receive we of the 11

treatment b+ can be taun office-basfor office-baost-utility an

ot be answeom the interfice-based awere prese

his study, weknow whetheor placebo tmonitor and

VAT regimenhe treatmenrstanding thnt as well asent effect werm benefit tudy we are

mp to Secti

group.

to who are as

m of vision st effective ieving

s.

a reported esigned ents were

ned for e less include

w-up. The weekly patients

because of ught to ed therapy

ased nalysis, this

ered at this action

and home-nt, and if e did not er the treatment d n, we do t protocol he nature s the

will be of

e

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University of Alabama at Birmingham School of Optometry, Birmingham (28): Dr Hopkins (PI); Marcela Frazier, OD, MPH (E); Janene Sims, OD (E); Marsha Swanson, OD (E); Katherine Weise, OD, MBA (E); Adrienne Broadfoot, MS, OTR/L (VT, SC); Michelle Anderson, OD (VT); and Catherine Baldwin (SC).

Nova Southeastern University, Ft Lauderdale, Florida (27): Dr Coulter (PI); Deborah Amster, OD (E); Gregory Fecho, OD (E); Tanya Mahaphon, OD (E); Jacqueline Rodena, OD (E); Mary Bartuccio, OD (VT); Yin Tea, OD (VT); and Annette Bade, OD (SC).

Pennsylvania College of Optometry, Philadelphia (25): Dr Gallaway (PI); Brandy

Scombordi, OD (E); Mark Boas, OD (VT); Tomohiko Yamada, OD (VT); Ryan Langan (SC), Ruth Shoge, OD (E); and Lily Zhu, OD (E).

The Ohio State University College of Optometry, Columbus (24): Dr Kulp (PI); Michelle Buckland, OD (E); Michael Earley, OD, PhD (E); Gina Gabriel, OD, MS (E); Aaron Zimmerman, OD (E); Kathleen Reuter, OD (VT); Andrew Toole, OD, MS (VT); Molly Biddle, MEd (SC); and Nancy Stevens, MS, RD, LD (SC).

Southern California College of Optometry, Fullerton (23): Dr Cotter (PI); Eric Borsting, OD, MS (E); Dr Rouse (E); Carmen Barnhardt, OD, MS (VT); Raymond Chu, OD, MS (VT); Susan Parker (SC); Rebecca Bridgeford (SC);

Jamie Morris (SC); and Javier Villalobos (SC).

University of California–San Diego Ratner Children's Eye Center, San Diego (17): Dr Granet (PI); Lara Hustana, OD (E); Shira Robbins, MD (E); Erica Castro (VT); and Cintia Gomi, MD (SC).

Mayo Clinic, Rochester, Minnesota (14): Dr Mohney (PI); Jonathan Holmes, MD (E); Melissa Rice, OD (VT); Virginia Karlsson, BS, CO (VT); Becky Nielsen (SC); Jan Sease, COMT, BS (SC); and Tracee Shevlin (SC).

CITT Study Chair

Dr Scheiman (study chair); Karen Pollack (study coordinator); Dr Cotter (vice chair); Dr Hertle (vice chair); and Dr Rouse (consultant).

CITT Data Coordinating Center

Ms Mitchell (PI); Tracy Kitts (project coordinator); Melanie Bacher

(programmer); Linda Barrett (data entry); Loraine Sinnott, PhD

(biostatistician); Kelly Watson (student worker); and Pam Wessel (office associate).

National Eye Institute, Bethesda, MD

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hell, MAS; MMaryann Rehabetical): Jd Granet, Mnna Tamkin

ERENCES

étourneau JEionship betwol achievem

9;56(1):18-2

étourneau JEentary scho

orcar E, Martlation of un

OF SCIENCE | P

ouse MW, Bong fifth and IENCE | PUBME

aum KM. CoWEB OF SCIENC

nd Paivi Misk

ve Commit

Ms Mitchell;

fety Monito

West, PhD (ays, PhD; AhD.

ing Commeatment Triathors: Mitch

Marjean Kulpdford, DDS,effrey CoopD; Kristine

ns, OD.

E, Lapierre Nween conver

ment. Am J O22. WEB OF SC

E, Ducic S. Pool children.

tinez-Palomiversity stud

PUBMED

orsting E, Hsixth grade

ED

onvergence E | PUBMED

kala, PhD.

ttee

; Dr Cotter;

oring Comm

chair); Rev rgye Hillis,

ittee: The fal Study Grohell Scheimap, OD, MS; M, MPH. Addi

per, MS, ODHopkins, OD

N, Lamont Argence insufOptom PhysiCIENCE | PUBM

Prevalence o Can J Opto

mera A. Prevdents. Opto

yman L; et ers. Optom V

insufficiency

Dr Hertle;

mittee

Andrew CosPhD (throug

following meoup take autan, OD; SusMichael Routional writin; Rachel CoD, MSPH; B

A. The fficiency andiol Opt. MED

of convergeom. 1988;50

alence of gem Vis Sci. 1

al. FrequenVis Sci. 199

y. Am J Opt

Dr Kulp; Dr

stello, CSsRgh March 20

embers of ththorship ressan Cotter, Ouse, OD, MEng committeulter, OD; Mrian G. Moh

d

nce insuffic0:194-197.

eneral binoc1997;74(2):

ncy of conve9;76(9):64

tom Physiol

Jum • Top


r Redford; a

R; William V006); and Ru

he Convergsponsibility OD, MS; G.

Ed; Richard ee membersMichael Gallhney, MD; a

iency amon

cular dysfun:111-113. F

ergence insu3-649. FULL

Opt. 1984;6

mp to Secti

oduction

hods

ults

mment

clusions

hor information

erences

nd Dr

. Good, uth

ence for the Lynn

Hertle, MD;s away, OD; nd

g

nctions in a ULL TEXT |

ufficiency TEXT | WEB

61(1):16-

on

6. Cotreat

7. Keperso

8. Podisab

9. Ma1971

10. DSyste

11. POpht

12. Bconve2003

13. BconveSci. 2

14. vof Str

15. ALiving

16. CPhila

17. PYork,

18. vLouis

19. GBosto

20. P1997

21. SAccomand W

22. HParal

23. Gtreat2002

24. Cconve

25. SconveSCIEN

ooper J, Ducment. J Am

ent PR, Steeonnel and re

oynter HL, Sbility. Am J O

azow ML. Th1;8:243-244

Duke-Elder Sem of Ophth

Pickwell LD, thalmic Phys

Borsting E, Rergence and

3;74(1):25-3

Borsting EJ, ergence ins2003;80(12

von Noordenrabismus. S

Abrams D. Dgstone; 199

Cibis G, Tongdelphia, PA

Pratt-Johnso, NY: Thiem

von Noordens, MO: Mosb

Griffin JR, Gon, MA: But

Press LJ. App7.

Scheiman Mmmodative Wilkins; 200

Hugonnier Rlysis. St Lou

Gallaway M, ment for co

2;79(4):265

Chin FH, Faiergence ins

Scheiman Mergence insCE | PUBMED

ckman R. Co Optom Ass

eve JH. Convelief by orth

Schor C, HayOptom Phys

he converge4.

S, Wybar K.halmology. S

Hampshire siol Opt. 198

Rouse MW, d accommod34. PUBMED

Rouse MW,ufficiency sy):832-838.

n GK. BinocuSt Louis, MO

Duke-Elder's93.

gue A, Stas: Mosby-Yea

on JA, Tillsone Medical P

n G, Helvestby-Year Boo

risham JD. Btterworth-He

plied Concep

, Wick B. Cland Eye Mo

02.

R, Clayette-Huis, MO: CV

Scheiman Monvergence i-267. FULL TE

bish B, Hisaufficiency. J

, Cooper J, ufficiency. O

onvergence soc. 1978;49

vergence insoptic metho

ynes HM, Hisiol Opt. 198

ence insuffic

Ocular motSt Louis, MO

R. The sign81;1(1):13-

Deland PN; dative insuff

Mitchell GLymptom surFULL TEXT | W

ular Vision aO: Mosby; 19

s Practice of

s-Isern M. Dar Book; 19

n G. Manageublishers; 2

ton E. Strabk; 1994.

Binocular Aneinemann; 2

pts in Vision

linical Managovement Dis

Hugonnier CMosby; 196

M, MalhotrainsufficiencyEXT | WEB OF

aka C, Thal LJ Beh Optom

Mitchell GL;Optom Vis S

insufficienc9(6):673-68

sufficiency: ods. Mil Surg

rsch J. Ocul82;59(2):11

ciency syndr

tility and strO: Mosby; 1

nificance of i-18. WEB OF S

et al. Assocficiency in s

L; et al. Valirvey in childWEB OF SCIENC

and Ocular M996.

f Refraction.

Decision Ma93.

ement of St2001.

ismus: A De

nomalies: D2002.

n Therapy. S

gement of Bsorders. Phi

C. Strabismu69.

K. The effey: a pilot stuSCIENCE | PUB

L, Tsuda K. m. 1995;6:9

; et al. A suSci. 2002;79

cy: incidence80. WEB OF SC

incidence arg. 1953;112

lomotor fun16-127. WEB

rome. J Pedi

rabismus. In1973.

inadequate SCIENCE | PUB

ciation of syschool-age c

dity and reldren aged 9CE | PUBMED

Motility: The

Edinburgh,

king in Pedi

trabismus an

ecision Maki

Diagnosis an

St Louis, MO

Binocular Visladelphia, P

us, Heteroph

ectiveness oudy. OptomBMED

A survey of91-92, 109.

rvey of trea9(3):151-15

e, diagnosisCIENCE | PUBM

among milita2(3):202-20

ctions in reaB OF SCIENCE |

iatr Ophthal

n: Duke-Eld

convergencBMED

ymptoms anchildren. Op

iability of th-18 years. O

eory and Ma

, Scotland:

iatric Ophth

nd Amblyop

king Approac

nd Vision Th

O: Mosby-Ye

sion: HeteroPA: Lippinco

horia and O

of pencil pusm Vis Sci.

f the treatm

atment mod57. FULL TEXT

s, and MED

ary 05. PUBMED

ading PUBMED

lmol.

der S, ed.

ce.

nd ptometry.

he revised Optom Vis

anagement

Churchill-

halmology.

pia. New

ch. St

erapy.

ear Book;

ophoric, tt, Williams

cular Motor

shups

ment of

alities for | WEB OF

r

26. SrandoFULL T

27. Cnons2002

28. Seffecsymp2005

29. Sof tre2005

30. S

31. KOpht

32. BinsufInsufFULL T

33. MconveOF SCI

34. TConvOpht

35. H2000

36. Rused 2002

37. CEarlb

38. Squest2005

39. BIn: HCamb

40. MWEB O

41. Bsympprelim

42. Gconve

Scheiman Momized cliniTEXT Ciuffreda KJtrabismic ac

2;73(12):73

Scheiman Mtiveness of ptomatic con5;89(10):13

Scheiman Meatments fo5;123(1):14

Sheard C. Zo

Kushner BJ. thalmol. 200

Borsting E, Rfficiency andfficiency andTEXT | WEB OF

Mitchell G, Sergence insIENCE | PUBME

The Convergvergence Insthalmic Epid

Hintze J. NC0.

Rouse MW, Hin the class

2;79(4):254

Cohen J. Stabaum Associ

Sloan JA, Cetionnaire da

5;58(12):12

Brody H. TheHarrington Abridge, MA:

Margo CE. TOF SCIENCE | P

Borsting E, Rptomatic accminary stud

Granet DB, Gergence ins

, Mitchell GLcal trial [rep

. The scientccommodati5-762. PUBM

, Cotter S, Rbase-in prisnvergence in18-1323. FR

, Mitchell GLr convergen-24. FREE FU

ones of ocul

The treatm05;123(1):1

Rouse MW, d normal bind Reading S SCIENCE | PU

Scheiman M,ufficiency pED

gence Insuffsufficiency Tdemiol. 2008

SS and PAS

Hyman L, Hsification of -264. FULL TE

atistical Powates; 1988.

ella D, Hays ata: another17-1219. FU

e doctor as A, ed. The Pl

Harvard Un

he placebo PUBMED

Rouse M, Chcommodativy. Optomet

Gomi CF, Veufficiency a

L, Cotter S;ply]. Arch O

ific basis foive and bino

MED

Rouse M; etsm reading nsufficiencyREE FULL TEXT

L, Cotter S;nce insufficieLL TEXT

lar comfort.

ent of conve100-101. FRE

De Land PNnocular childStudy (CIRS)UBMED

, Borsting Eatients. Opt

ficiency TreaTreatment T8;15(1):24-

SS. Kaysville

ussein M. RconvergencEXT | WEB OF

wer Analyses.

RD. Clinicar step towarULL TEXT | WEB

a therapeutlacebo Effecniversity Pre

effect. Surv

hu R. Measuve dysfunctitry. 2005;76

entura R, Mind ADHD. S

et al. ConvOphthalmol.

r and efficacocular vision

t al. Randomglasses vers

y in children

et al. A ranency in child

Am J Optom

ergence insEE FULL TEXT

. Prospectivdren on CIR) group. Op

; et al. Evaltom Vis Sci.

atment TrialTrial: design36. FULL TEXT

e, UT: Numb

Reliability of ce insufficienSCIENCE | PUB

s for the Beh

l significancrd consensuB OF SCIENCE

tic agent: a ct: An Interdess; 1997.

v Ophthalmo

uring ADHD on or conve6(10):588-5

iller-ScholteStrabismus.

vergence ins2005;123(

cy of optomn disorders.

mised clinicasus placebo. Br J Ophth

ndomized trdren. Arch O

m. 1930;7:

ufficiency [e

ve comparisS symptom

ptom Vis Sci

luation of a 2001;78(1

l (CITT) Stun, methods, T | WEB OF SC

ber Crunche

binocular vncy. Optom BMED

havioral Scie

ce of patientus. J Clin Epi| PUBMED

placebo effdisciplinary

ol. 1999;44(

behaviors inergence insu592. PUBMED

e A. The rela2005;13(4)

sufficiency: 12):1760-1

metric vision Optometry

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CIENCE | PUBM

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(1):31-44. F

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