1040-5488/13/9005-0475/0 VOL. 90, NO. 5, PP.

475Y481
OPTOMETRY AND VISION SCIENCE
Copyright * 2013 American Academy of Optometry

ORIGINAL ARTICLE

Feasibility of a Clinical Trial of Vision Therapy

for Treatment of Amblyopia
Don W. Lyon*, Kristine Hopkins†, Raymond H. Chu*, Susanna M. Tamkins‡, Susan A. Cotter§,
B. Michele Melia||, Jonathan M. Holmes**, Michael X. Repka††, David T. Wheeler‡‡, Nicholas A. Sala§§,
Janette Dumas||||, and David I. Silbert‡‡, on behalf of the Pediatric Eye Disease Investigator Group

ABSTRACT
Purpose. We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of child-
hood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial.
Methods. A training and certification program and manual of procedures were developed to certify therapists to adminis-
ter a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks.
Nineteen children, aged 7 to less than 13 years, with amblyopia (20/40Y20/100) were randomly assigned to receive either
2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy.
Results. Therapists in diverse practice settings were successfully trained and certified to perform standardized vision
therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eli-
gibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized
vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects
being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the
computerized home therapy procedures.
Conclusions. This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to
maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the stan-
dardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the
treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective
data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual
acuity, and stereopsis might be required to allow enrollment of a broader group of subjects.
(Optom Vis Sci 2013;90:475Y481)

Key Words: amblyopia, patching, vision therapy, placebo vision therapy, masking

T
*OD, MS, FAAO reatment with patching and/or atropine is effective in
†
OD, MSPH, FAAO improving visual acuity in children with unilateral
‡
§
OD, FAAO amblyopia,1Y7 but reduced visual acuity is not the only vi-
OD, MS sual defect associated with amblyopia. Deficiencies in accom-
||
ScM
**BM, BCh
modation,8Y10 contrast sensitivity,11,12 fixation,11,13,14 eye
††
MD, MBA movements,15,16 binocular function,17Y19 motion detection,20 and
‡‡
MD vernier acuity11 have been reported to occur in amblyopic eyes.
§§
DO Thus, as an adjunct to conventional amblyopia treatment with
||||
OD refractive correction and occlusion, some eye care providers pre-
Indiana University School of Optometry, Bloomington, Indiana (DWL); School
of Optometry, University of Alabama at Birmingham, Birmingham, Alabama (KH);
scribe active vision therapy to specifically address these deficiencies
Southern California College of Optometry, Fullerton, California (RHC, SAC); in visual function.21Y26
Bascom Palmer Eye Institute, Miami, Florida (SMT); Jaeb Center for Health Vision therapy for amblyopia consists of a sequence of visual
Research, Tampa, Florida (MM); Department of Ophthalmology, Mayo Clinic, activities prescribed to facilitate the effects of refractive correc-
Rochester, Minnesota (JMH); Johns Hopkins University School of Medicine, tion and occlusion by directly treating other aspects of visual
Baltimore, Maryland (MXR); Casey Eye Institute, Portland, Oregon (DTW);
Pediatric Ophthalmology of Erie, Erie, Pennsylvania (NAS); Southern College of
function, such as accommodation, eye movements, and suppres-
Optometry, Memphis, Tennessee (JD); and Family Eye Group, Lancaster, sion.22Y26 There is a clinical impression that active vision ther-
Pennsylvania (DIS). apy can not only speed visual acuity improvement but also may

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Copyright © American Academy of Optometry. Unauthorized reproduction of this article is prohibited.

476 Clinical Trial Feasibility of Vision Therapy for AmblyopiaVLyon et al.

reduce the likelihood of amblyopia recurrence/regression, espe- The specific objectives of the feasibility phase of the trial were
cially for anisometropic amblyopia.27 Vision therapy for ambly- to (1) determine the availability of eligible subjects and willing-
opia is often administered in the office on a weekly basis by ness of subjects to be randomized to the proposed treatments;
a therapist under the supervision of an eye care provider and (2) determine participant adherence to the treatment protocol
supplemented by similar therapy procedures prescribed to be (i.e., weekly visits), particularly those assigned to placebo vision
completed at home to reinforce visual skills. The effectiveness therapy; (3) test procedures developed to train and certify thera-
of vision therapy for amblyopia treatment has not been evalu- pists to administer both active and placebo vision therapy ac-
ated in randomized clinical trials. cording to protocol; (4) identify possible problems with training
To evaluate the effectiveness of active vision therapy for the and implementation at the clinical sites; (5) evaluate the feasibil-
treatment of childhood amblyopia, the Pediatric Eye Disease ity of successfully delivering the office-based vision therapy pro-
Investigator Group (PEDIG) designed a clinical trial of 7- to gram at the PEDIG sites, particularly those with no previous
less than 13-year-old children with amblyopia who would be experience with in-office vision therapy; and (6) determine the
randomized to treatment using 2 hours of daily patching with success of masking the subjects and parents to their assigned
active vision therapy or to 2 hours of daily patching with placebo treatment group.
vision therapy. Treatment consisted of 16 weekly in-office vision
therapy visits with a trained therapist and the use of computer Site and Subject Selection
therapy in the office and at home. The primary outcome was
Clinical sites were selected based on their interest in the study
the proportion of subjects with 20/25 or better visual acuity in
or record of strong recruitment in past PEDIG amblyopia stud-
the amblyopic eye as measured using the eETDRS (electronic
ies. The recruitment goal for the feasibility phase of the trial was
Early Treatment Diabetic Retinopathy Study) protocol28 assessed
45 subjects during a 1-year period, with each site enrolling six
at 17 weeks by a masked examiner. The sample size was deter-
to seven subjects, but not more than 10 per site, to allow all sites
mined to be 222 subjects. Because most PEDIG investigators did
to gain experience with the protocol. Major eligibility criteria
not offer office-based vision therapy in their practices, the im-
included age 7 to less than 13 years; amblyopia associated with
plementation of this protocol would require a significant effort
anisometropia, strabismus, or both; visual acuity 20/40 to 20/100
in training therapists to administer the vision therapy in a stan-
in the amblyopic eye and 20/25 or better in the fellow eye;
dardized manner. In addition, there were concerns regarding
interocular visual acuity difference of three or more logarithm
subjects’ willingness to participate in an amblyopia treatment trial
of the minimum angle of resolution (logMAR) lines; at least
that required 16 weekly office visits and whether they would ad-
800 seconds of arc on the Randot Preschool Stereoacuity test;
here to weekly office visits, the research cost associated with the
single-vision spectacles (if needed) worn for at least 16 weeks or
training of vision therapists and equipment needed for partici-
until amblyopic eye visual acuity was documented to be stable
pating clinical sites, and the ability to recruit a sufficient num-
(defined as two consecutive visual acuity measurements by the
ber of eligible subjects. Therefore, an initial ‘‘feasibility’’ phase
same testing method at least 4 weeks apart with no improve-
was implemented at seven clinical sites.
ment of Q1 logMAR line); no previous vision therapy or or-
The primary objective of this phase was to determine the fea-
thoptics; and daily access to a computer (Internet access not
sibility of a full-scale randomized clinical trial, including whether
required). Constant strabismus at near at the time of the eligibil-
the investigator group could recruit a sufficient number of eli-
ity examination was an exclusion criterion. Table 1 provides a
gible subjects and conduct the study according to the proposed
complete listing of eligibility and exclusion criteria. Eye patches,
protocol. The decision to continue the study (i.e., add additional
therapy visits, and vision therapy equipment, including the com-
clinical sites and recruit the full sample size) was predicated on
puter program, were provided free of charge to the subjects.
the success of the feasibility phase of the study. Herein, we re-
port the results of the feasibility phase of this randomized clini-
Randomization and Treatment Protocols
cal trial of active vision therapy for the treatment of amblyopia.
After informed consent was obtained and eligibility was con-
firmed, participants were randomly assigned with equal proba-
METHODS
bility to receive either active vision therapy or placebo vision
The study, supported through a cooperative agreement with therapy using a master randomization list with a permuted block
the National Eye Institute of the National Institutes of Health, design stratified by site. The treatment regimen for both treat-
Bethesda, MD, was conducted by the PEDIG at seven clinical ment groups was 2 hours of daily patching of the nonamblyopic
sites (four optometry based and three ophthalmology based). eye during which 30 minutes were to be devoted to performing
Respective institutional review boards approved the protocol near activities and 30 minutes to computerized home therapy
and HIPAA (Health Insurance Portability and Accountability and a weekly 45-minute in-office vision therapy session with a
Act)-compliant informed consent forms. A parent or guardian therapist. Near activities were the same in both groups and
(referred subsequently as ‘‘parent’’) of each child gave written consisted of activities performed within arms’ reach using eye-
informed consent, and the children gave assent as required. The hand coordination such as crafts, coloring, video games, written
study adhered to the tenets of the Declaration of Helsinki, and homework or reading. Subjects in both groups were scheduled
an independent data safety and monitoring committee provided for 16 consecutive weekly in-office therapist-supervised ther-
study oversight. The study was listed on clinicaltrials.gov (ID apy sessions. The treatment regimen difference between the two
NCT00587171). groups was that the active group performed active vision therapy

Optometry and Vision Science, Vol. 90, No. 5, May 2013

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 Clinical Trial Feasibility of Vision Therapy for AmblyopiaVLyon et al. 477
TABLE 1.
Study eligibility and exclusion criteria

Eligibility criteria

1. Age 7 Y G13 yr
2. Amblyopia associated with anisometropia, strabismus (comitant or incomitant), or both*
3. No constant strabismus at near
4. Visual acuity, measured using the eETDRS protocol28 on the EVA (Electronic Visual Acuity Tester)29 meeting the following criteria:
& Best-corrected visual acuity in the amblyopic eye between 49 and 71 letters inclusive (20/40 to 20/100 inclusive)
& Best-corrected visual acuity in the sound eye 79 or more letters (Q20/25)
& Inter-eye acuity difference 15 or more letters (Q3 logMAR lines) (i.e., amblyopic eye acuity at least three lines worse than sound
eye acuity)
5. Single-vision spectacles, if needed, worn for at least 16 weeks or until visual acuity documented to be stable (bifocals not allowed)
6. Near stereoacuity of 800 seconds of arc or better on the Randot Preschool Stereoacuity test
7. No previous home-based, office-based, or computerized vision therapy or orthoptics
8. Previous or current amblyopia treatment with spectacles, contact lenses, patching, or atropine is permitted. At the time of enrollment,
the patient must be:
& currently patching for 2 h/d,
& ready to be switched to 2 h/d of patching from another patching dose or from atropine, or
& not currently on treatment (other than spectacles or contact lenses) and ready to initiate patching for 2 h/d
9. No known skin reactions to patch or bandage adhesives
10. Cycloplegic refraction within 6 mo before enrollment
11. Ocular examination within 6 mo before enrollment revealing no ocular cause for reduced visual acuity
12. No developmental disability, mental retardation, or learning disability diagnosis that in the investigator’s judgment would
interfere with treatment
13. Children with ADHD (attention-deficit hyperactivity disorder) may be enrolled if the investigator feels that the patient could
still properly perform the therapy activities
14. No myopia more than j6.00 D spherical equivalent in the amblyopic eye
15. No previous intraocular or refractive surgery
16. Parent does not anticipate relocation outside area of active study site within the next 5 mo
17. Patient and parent are willing to accept randomization and be available for 17 consecutive weeks of office visits and follow-up
18. Siblings of patients already enrolled in this study and children of ophthalmologists, optometrists, orthoptists, and vision therapists
are excluded
19. Subject must have access to a computer on a daily basis
*Subjects with strabismus or combined-mechanism etiology for amblyopia cannot have constant strabismus at near at the time of the
eligibility examination.

procedures during the in-office sessions as well as for the com- iNet program, in which the initial target size corresponded to
puterized home therapy, whereas the control group performed 20/200 and automatically decreased to 20/100 at the 8-week
placebo vision therapy procedures in the office and at home. interval. Objectives and goals were established for each proce-
All subjects and their parents were masked to treatment as- dure in both treatment groups to motivate subjects to engage
signment, and every attempt was made to maintain masking dur- in the activities. Therapists were instructed to encourage all sub-
ing the trial. The active vision therapy procedures consisted of jects regardless of treatment assignment. A copy of the in-office
standard accommodative amplitude and facility, vergence (e.g., active and placebo vision therapy Manuals of Procedures de-
free-space fusion cards, vectographs, computerized therapy), and signed for this study can be downloaded at http://pedig.jaeb.org/
antisuppression (e.g., Brock string, anaglyphic drawing) therapy Studies.aspx?RecID=35.
procedures. All vergence activities required subjects to have nor-
mal peripheral sensory fusion, and some required appreciation of
Training/Certification of Therapists and
random dot stereopsis. The home therapy activities for the active
Quality Assurance
therapy group required subjects to spend a total of 30 minutes
on computer-based programs including Amblyopia iNet and The Manual of Procedures specified that each clinical site have
HTS (HTS Inc., Gold Canyon, AZ). The in-office placebo ther- at least one certified therapist whose qualifications were being
apy included visual perceptual activities such as parquetry blocks an optometrist, ophthalmologist, orthoptist, occupational therapist,
and the VIPS (Visual Information Processing Skills) compo- or vision therapist. Training and certification procedures for all
nent of the CAVT (Computer Aided Vision Therapy) program therapists were to review the Manual of Procedures, watch a
(Bernell, Mishawaka, IN). These activities were performed with DVD-based training program that was developed specifically for
both eyes open instead of with the nonamblyopic eye patched, the study, successfully complete a written examination, demon-
and lens flippers with plano lenses, yoked prism, or neutral strate proficiency with the in-office vision therapy procedures
density filters were used. Placebo home therapy consisted of (both active and placebo) at a study training and certification
30 minutes of computer therapy with a version of the Amblyopia session, and submit treatment progress reports for two test

Optometry and Vision Science, Vol. 90, No. 5, May 2013

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478 Clinical Trial Feasibility of Vision Therapy for AmblyopiaVLyon et al.

patients. Any therapist not having a minimum of 60 hours of RESULTS

experience with in-office vision therapy in the previous year or
unable to attend the study certification session was initially given
Recruitment and Retention
provisional certification on fulfillment of all other criteria; full Between April 2008 and March 2009, 19 subjects (nine with
certification status was conferred after a steering committee mem- anisometropic, two with strabismic, and eight with combined
ber observed the therapist administering in-office vision therapy per mechanism amblyopia) were enrolled at seven sites (14 from
protocol to study participant(s). Additional quality assurance mea- optometry-based sites and five from ophthalmology-based sites);
sures included a therapy session evaluation at a site visit performed nine were randomly assigned to active vision therapy and 10 were
during the course of the study and review by a protocol chair of the assigned to placebo vision therapy. One site recruited 10 sub-
therapists’ notes from all completed vision therapy sessions to ensure jects, three sites recruited two subjects each, and the remaining
that the treatment protocol was followed appropriately. three sites each recruited one subject. One subject’s parents re-
A priori, it was determined that the ability to train therapists quested their child be dropped from the study after randomi-
successfully would be measured by the number of errors during zation. Another subject completed 12 weeks of vision therapy
the vision therapy phase occurring during the study. Errors were but did not complete the 17-week outcome visit. All other sub-
defined as subjects receiving nonassigned vision therapy or ad- jects completed the study.
vancing through the phases of vision therapy more quickly or Based on reports from the investigators on monthly confer-
slowly than specified by protocol. A protocol chair identified ence calls, recruitment was limited largely by the stringent eligi-
vision therapyYrelated deviations after review of the weekly in- bility criteria, including the combined requirements of at least
office vision therapy forms completed by the therapists. 800 seconds of arc of random dot stereopsis at near on the Randot
Preschool Stereotest, visual acuity in the amblyopic eye of 20/40
Adherence with Home Vision Therapy and Patching to 20/100, and the minimum age of at least 7 years. In addition,
sites were requested to document all children who were screened
At each of the weekly follow-up visits, the therapists reviewed
for the study for an approximate 2-month period (actual period
the subject’s written log of the number of hours spent patch-
varied by site depending on time of institutional review board
ing and doing computer activities each day and inquired about
approval). During this period, there were six children who were
the subject’s adherence to the home therapy and patching. For
eligible but failed to enroll, 140 children with amblyopia who
subjects who had Internet access at home, the therapist was
were not eligible, and four children who were enrolled. The most
instructed to review an online log of the computerized activities
frequent reasons for failure to enroll of an eligible child were liv-
performed each day at home, automatically recorded by the
ing too far from the site and unwillingness to wear spectacles/
computer program and uploaded to a protected database each
poor compliance with spectacles each reported for two children.
night. Subjects who did not have home Internet access received
The most frequent reasons for ineligibility were visual acuity
instructions to copy the log files onto a USB drive and bring it to
not between 20/40 and 20/100 (54 children, 39%), intraocu-
the weekly in-office visit for review. Time spent doing general
lar difference of less than three lines (30 children, 21%), age
near activities while patching was not monitored. Adherence to
younger than 7 years or older than 12 years (26 children, 19%),
patching and home therapy was scored separately (excellent when
Randot near stereoacuity less than 800 arc seconds (25 children,
76 to 100% of prescribed treatment completed; good, 51 to 75%;
18%), and constant strabismus at near (12 children, 9%; per-
fair, 26 to 50%; and poor, e25%). Adherence determination was
centages sum to more than 100% because some children had
completed before the subject’s visual acuity was measured.
multiple reasons for ineligibility). Other reasons for ineligibility
applied to less than 3% of children. We did not identify any
Masking Assessment
issues related to specific sites that affected recruitment.
During the initial verbal consent process and as part of the Subjects in each group completed a similar number of the
written informed consent, parents and subjects were informed 16 weekly in-office vision therapy visits. On average, 2.5 treat-
that, at each office visit, a therapist would treat the child with ment visits were missed per subject for an overall completion rate
active vision therapy or activities that were not believed to help of 85%, with those in the active treatment group having more
his or her vision (control therapy). At the 17-week outcome visit, missed office vision therapy visits compared with those in the
the therapist independently queried both the subjects and parents placebo group (3.0 vs. 2.0 visits). The proportion of subjects
regarding which treatment group they thought they or their child completing the 17-week masked outcome examination was not
was assigned by asking the child ‘‘what treatment do you believe different between the active (89%) and the placebo (90%) vision
that you received?’’ when the parent was not present and asking therapy groups.
the parent ‘‘what treatment do you believe your child received?’’
when the child was not present. Masking of subjects and parents
Protocol Adherence
was defined as successful if, at the conclusion of the study, the
proportion of subjects (and respective parents) able to correctly Two major protocol deviations were noted during the 256
identify the treatment assignment was statistically not different treatment visits of the trial. One placebo group subject received
from or less than predicted by chance (50%). This corresponded active vision therapy at the first in-office visit. Another subject
to less than 30 (67%) subjects/parents identifying the treatment was initially given the incorrect home therapy computer disk;
assignment correctly as the criterion for successful masking based however, this was discovered before the subject used the pro-
on a sample size of 45. gram and the correct program was subsequently provided to the

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 Clinical Trial Feasibility of Vision Therapy for AmblyopiaVLyon et al. 479

subject. In addition, there were four instances where the in-office The recruitment goal of one subject per month per site was
vision therapy was not fully completed at that visit because of met by only one of the seven clinical sites, with total recruitment
time constraints. There was one instance where a subject was reaching only 42% of the goal. Thus, the full-scale randomized
moved into the second phase of the vergence therapy despite not clinical trial was deemed to not be feasible based on insufficient
meeting the criteria for phase 1. recruitment. The reason for insufficient recruitment was largely
caused by the combined eligibility criteria for visual acuity, ste-
Adherence with Home Vision Therapy reoacuity, and age. This was the first PEDIG amblyopia study
with these eligibility criteria; in particular, no previous PEDIG
Home adherence with the computer program could not be amblyopia study had a minimum stereoacuity requirement. Many
objectively assessed because only about 50% of subjects reported children whose visual acuity and/or intraocular difference were
their results online or brought their data storage devices to study not in the eligible range had amblyopic eye visual acuity that
visits. Participant adherence to the prescribed home therapy based was better than 20/40 after treatment with spectacles alone. These
on the written logs (completed by a parent) and discussion with children would not be the best candidates for an amblyopia
the parent was judged subjectively by therapists to be excellent treatment trial because of limited room for further improve-
in 88%, good in 12%, fair in 0%, and poor in 0% of subjects ment. It was thought that allowing children with visual acuity
assigned to active vision therapy. For the placebo vision therapy worse than 20/100 would require significant changes to the treat-
group, adherence was judged to be excellent in 70%, good in ment protocol. This would have significantly increased sample
20%, fair in 10%, and poor in 0% of subjects. size if those subjects were treated and analyzed as a separate co-
hort. As we learn more about children with severe amblyopia and
Subject Masking how they respond to traditional therapy, there could be justifi-
cation to include subjects with poorer visual acuity. Whereas
At the 17-week outcome visit, 100% (8 of 8) of those sub-
recruitment might have benefited if a less stringent stereoacuity
jects assigned to active vision therapy and 67% (6 of 9 subjects)
requirement had been used, presence of random dot stereopsis
of those assigned to placebo vision therapy reported that they
was considered necessary because many of the office-based active
thought they were assigned to the active vision therapy regimen.
vision therapy procedures for vergence and antisuppression re-
This corresponded to 65% (95% confidence interval [CI], 38
quired fusion and stereopsis to perform the task. The lower age
to 86%) of subjects correctly identifying their treatment assign-
limit of 7 years was specifically chosen because children younger
ment. Fifty percent (4 of 8) of the parents of those assigned to
than 7 years often have difficulty understanding many of the
active vision therapy and 55% (5 of 9) of the parents of those
vision therapy procedures. The upper age limit was based on a
assigned to placebo vision therapy reported that they thought
previous Amblyopia Treatment Study,7 which showed less im-
their child received the active vision therapy, corresponding to
provement for children older than 12 years than for younger
47% (95% CI, 23 to 72%) of parents correctly identifying their
children with conventional treatment of occlusion and/or atro-
child’s treatment assignment. The overall percentage of correct
pine. We were attempting to maximize the benefit of vision
guesses was not statistically different from 50% for either sub-
therapy, if it existed. If subjects with less than 800 seconds of
jects or parents; however, as the full feasibility phase sample size
stereopsis and/or younger than 7 years had been included, mod-
was not reached, the CI on this percentage was wider than
ifications to the active vision therapy protocol that allowed for
planned, and we were unable to reach a definitive conclusion
the vision therapy to be customized based on the subject’s age
regarding success of masking.
and stereoacuity would have been necessary. For this initial study,
we decided to adopt more stringent criteria for stereoacuity and
age to allow for a uniform approach to the active vision therapy
DISCUSSION
program. Future studies may need to consider a more flexible
This feasibility study was performed to evaluate potential dif- approach, customized according to subject age, visual acuity, and
ficulties in conducting a proposed randomized clinical trial to stereopsis that would allow a broader range of children with
evaluate the effectiveness of a 16-week office-based regimen of amblyopia to be enrolled. However, a more flexible approach to
active vision therapy for the treatment of childhood amblyopia. the vision therapy treatment protocol would complicate train-
Experience from this feasibility study, using the study design and ing and certification and could conceivably result in increased
treatment regimens developed for the intended clinical trial, was variation in treatment effect.
to be used to identify any issues related to recruitment, retention, There were also difficulties with the method used to objec-
certification of therapists, adherence with study visits and home- tively monitor the computerized home therapy. A number of
based treatment, and the masking of participants and their par- subjects without Internet access who were instructed to store
ents. The results of this study showed that, once enrolled into their computer therapy performance on USB drives and bring
this multicenter treatment trial of in-office vision therapy for the drives to their vision therapy appointments either did not
the treatment of amblyopia, few subjects missed study visits and understand how to download the computer therapy performance
most completed the entire 16-week treatment program. In ad- to USB devices or did not bring the devices to the treatment
dition, there was good adherence to the prescribed weekly in- visits. This made it impossible to obtain adequate data regard-
office vision therapy. However, both recruitment and the ability ing computerized home therapy adherence and performance.
to monitor adherence objectively with computerized home ther- For future studies that use computerized home therapy with In-
apy were problematic. ternet monitoring either as an adherence or an outcome measure,

Optometry and Vision Science, Vol. 90, No. 5, May 2013

Copyright © American Academy of Optometry. Unauthorized reproduction of this article is prohibited.

480 Clinical Trial Feasibility of Vision Therapy for AmblyopiaVLyon et al.

Internet access to facilitate documentation of computerized home 2. Swann AP, Hunter CD. A survey of amblyopia treated by atro-
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aged 7 to younger than 13 years can adhere to 16 weeks of in- SA, Hertle RW, Kraker RT, Moke PS, Quinn GE, Scheiman MM,
office vision therapy program for amblyopia treatment and that Pediatric Eye Disease Investigator Group. A randomized trial of
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ful completion of a randomized clinical study of in-office vision Stager DR, Sr., Wallace DK, Pediatric Eye Disease Investigator
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Holmes JM, Lyon DW, Repka MX, Sala NA, Silbert DI, Suh
ACKNOWLEDGMENTS DW, Tamkins SM, Pediatric Eye Disease Investigator Group.
Randomized trial of treatment of amblyopia in children aged 7 to
Supported through a cooperative agreement from the National Eye Institute 17 years. Arch Ophthalmol 2005;123:437Y47.
of the National Institutes of Health, Bethesda, MD (EY011751 and 8. Ciuffreda KJ, Hokoda SC, Hung GK, Semmlow JL, Selenow A.
EY018810). The funding organization had no role in the design or conduct
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of this research. The authors have no conflicts of interest to disclose.
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