AmblyopiaATS20NCT02983552
Binocular Dig Rush Game Treatment for Amblyopia
A study testing iPad® and Spectacle correction in people with Amblyopia, run by Jaeb Center for Health Research at 62 sites in 2 countries.
Trial summary
To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- iPad® and Spectacle correction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 62 sitesin 2 countries
- Study dates
- 2 Mar 2017to 10 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4 to <13 years
- Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
- Criteria for strabismic amblyopia: At least one of the following must be met:
- Presence of a heterotropia on examination at distance or near fixation (with or without optical correction, must be no more than 5pd by SPCT at near fixation (see #6 below)
- Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
- Criteria for anisometropia: At least one of the following criteria must be met:
Show all 40Show fewer
- ≥1.00 D difference between eyes in spherical equivalent
- ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
- Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:
- Criteria for strabismus are met (see above)
- ≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
- No amblyopia treatment other than optical correction in the past 2 weeks (patching, atropine, Bangerter, vision therapy, binocular treatment)
- Requirements for required refractive error correction (based on a cycloplegic refraction completed within the last 7 months):
- Hypermetropia of 2.50 D or more by spherical equivalent (SE)
- Myopia of amblyopic eye of 0.50D or more SE
- Astigmatism of 1.00D or more
- Anisometropia of more than 0.50D SE
- NOTE: Subjects with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.
- Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:
- SE must be within 0.50D of fully correcting the anisometropia.
- SE must not be under corrected by more than 1.50D SE, and reduction in plus sphere must be symmetric in the two eyes.
- Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.
- Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is >1.00D.
- Myopia must not be undercorrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
- Spectacle correction meeting the above criteria must be worn:
- For at least 16 weeks OR until VA stability is documented (defined as <0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
- For determining VA stability (non-improvement):
- The first of two measurements may be made 1) in current spectacles, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),
- The second measurement must be made without cycloplegia in the correct spectacles that have been worn for at least 8 weeks.
- Note: since this determination is a pre-study procedure, the method of measuring VA is not mandated.
- VA, measured in each eye without cycloplegia in current spectacle correction (if applicable) within 7 days prior to randomization using the ATS-HOTV VA protocol for children < 7 years and the E-ETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:
- VA in the amblyopic eye 20/40 to 20/200 inclusive (ATS-HOTV) or 33 to 72 letters (E-ETDRS)
- VA in the fellow eye 20/25 or better (ATS-HOTV) or ≥ 78 letters (E-ETDRS)
- Interocular difference ≥ 3 logMAR lines (ATS-HOTV) or ≥ 15 letters (E-ETDRS)
- Heterotropia with a near deviation of ≤ 5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation >5∆ are not allowed because large magnitudes of the deviation would compromise successful playing of the game.)
- Subject is able to play the Dig Rush game (at least level 3) on the study iPad under binocular conditions (with red-green glasses). Subject must be able to see both the red "diggers" and blue "gold carts" when contrast for the non-amblyopic eye is at 20%.
- Investigator is willing to prescribe computer game play, or continued spectacle wear per protocol.
- Parent understands the protocol and is willing to accept randomization.
- Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.
- Relocation outside of area of an active PEDIG site for this study within the next 8 weeks is not anticipated.
Who cannot join
- Prism in the spectacle correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).
- Myopia greater than -6.00D spherical equivalent in either eye.
- Previous intraocular or refractive surgery.
- Any treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy or previous binocular treatment) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks prior to enrollment.
- Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above VA criteria are met).
- No Down syndrome or cerebral palsy
- No severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded.
- Subject has demonstrated previous low compliance with binocular treatment and/or spectacle treatment (as assessed informally by the investigator)
Trial locations and contacts
62 sites in 2 countries.
62 sites in 2 countries
United States61 sites
University Eye Center at Ketchum Health
Anaheim, California, 92807
The Emory Eye Center
Atlanta, Georgia, 30322
Greater Baltimore Medical Center
Baltimore, Maryland, 21204-5809
Wilmer Eye Institute
Baltimore, Maryland, 21287
Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan, 49307
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, 35294
Indiana School of Optometry
Bloomington, Indiana, 47405
St Luke's Hospital
Boise, Idaho, 83702
Boston Children's Hospital
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27599-7040
Pediatric Eye Specialists
Chattanooga, Tennessee, 37421
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Illinois College of Optometry
Chicago, Illinois, 60616
Ticho Eye Associates
Chicago Ridge, Illinois, 60415
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio, 43205
The Ohio State University College of Optometry
Columbus, Ohio, 43210-1280
Concord Ophthalmologic Associates
Concord, New Hampshire, 03301
Duke University Eye Center
Durham, North Carolina, 27710
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, 16501
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, 33382
University of Florida Shands Hospital
Gainesville, Florida, 32608
Midwestern University Eye Institute
Glendale, Arizona, 85308
Helen DeVos Children's Hospital Pediatric Ophthalmology
Grand Rapids, Michigan, 49503
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, 49546
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas, 77030
University of Houston College of Optometry
Houston, Texas, 77204
Marshall University
Huntington, West Virginia, 25755
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Conestoga Eye
Lancaster, Pennsylvania, 17601
Snowy Range Vision Center
Laramie, Wyoming, 82070
Progressive Eye Care
Lisle, Illinois, 60532
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, 92354
Texas Tech University Health Science Center
Lubbock, Texas, 79430
University of Wisconsin, University Station
Madison, Wisconsin, 53705
Michael F. Gallaway, O.D., P.C.
Marlton, New Jersey, 08053
Southern College of Optometry
Memphis, Tennessee, 38104
University of Minnesota-Minnesota Lions Children's Eye Clinic
Minneapolis, Minnesota, 55454
Saddleback Eye Medical Associates
Mission Viejo, California, 92691
Yale University
New Haven, Connecticut, 06511
State University of New York, College of Optometry
New York, New York, 10036
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502
Dean A. McGee Eye Institute, University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68114
Eye Care Associates, Inc.
Poland, Ohio, 44514
Western University College of Optometry
Pomona, California, 91766
Pacific University College of Optometry
Portland, Oregon, 97205
OHSU Casey Eye Institute
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
San Antonio Eye Center
San Antonio, Texas, 78215
Advanced Vision Center
Schaumburg, Illinois, 60194
Seattle Children's Hospital, University of Washington
Seattle, Washington, 98105
Northwest Pediatric Ophthalmology, P.S.
Spokane, Washington, 99202
Spokane Eye Clinical Research
Spokane, Washington, 99204
Saint Louis University Institute
St Louis, Missouri, 63103
St. Louis Children's Hospital Eye Center
St Louis, Missouri, 63110
U of MO St. Louis College of Optometry
St Louis, Missouri, 63121
Houston Eye Associates
The Woodlands, Texas, 77381
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
Pediatric Eye Associates
Wilmette, Illinois, 60091
About this study
To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.
Read the detailed description
The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.
- Conditions
- Amblyopia
- Being tested
- iPad®, Spectacle correction
- Keywords
- Amblyopia
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPad®Other
Binocular therapy using a Dig Rush application on an iPad®
Spectacle correctionOther
Spectacle correction for all waking hours, 7 days per week
| Study group | Role | What they receive |
|---|---|---|
| Binocular Computer Game Treatment | Experimental | Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) Receives: Other: iPad® |
| Continued Spectacle Correction | Active comparator | Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. Receives: Other: Spectacle correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Measured: Baseline and 4 weeks
Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Measured: 4 weeks
Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Measured: Baseline and 8 weeks
Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Measured: 8 weeks
Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Measured: baseline and 4 weeks
Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Measured: 4 weeks
Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Measured: Baseline and 8 weeks
Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Measured: 8 weeks
Primary Outcome Measure (Older Cohort) Stratified by Sex
NIH-required analysis, stratified by sex.
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Measured: 4 Weeks
Primary Outcome Measure (Older Cohort) Stratified by Race/Ethnicity
NIH-required analysis, stratified by race/ethnicity.
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Measured: 4 Weeks
Primary Outcome Measure (Younger Cohort) Stratified by Sex
NIH-required analysis, stratified by sex.
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Measured: 4 Weeks
Primary Outcome Measure (Younger Cohort) Stratified by Race/Ethnicity
NIH-required analysis, stratified by race/ethnicity.
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.
For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Measured: 4 Weeks
Secondary outcomes (32)
VA Improvement at 4 Weeks Defined as a Binary Outcome
A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.
Measured: At 4 weeks
VA Improvement at 8 Weeks Defined as a Binary Outcome
A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 8 weeks after baseline.
Measured: At 8 weeks
Distribution of Stereoacuity Scores at 4 Weeks
Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Measured: 4 weeks
Distribution of Change in Stereoacuity Scores From Baseline
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
Measured: 4 weeks
Distribution of Stereoacuity Scores at 8 Weeks
Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Measured: 8 weeks
Distribution of Change in Stereoacuity Scores From Baseline
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 8-week stereoacuity scores.
Measured: 8 weeks
Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Measured: 4 weeks
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
Measured: 4 weeks
Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.
Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Measured: 8 weeks
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
Measured: 8 weeks
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast
Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment (participants completion of >75% of prescribed game play). The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group, as well as throughout 8 weeks. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.
Measured: 4 weeks
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast
Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 8 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.
Measured: 8 weeks
Treatment Compliance With Spectacle Wear
Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') for the initial 4 weeks. Patient reported to have completed >75% of spectacle wear at 4 weeks.
Measured: 4 weeks
Treatment Compliance With Spectacle Wear
Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') across 8 weeks. Patient reported to have completed >75% of spectacle wear at 8 weeks.
Measured: 8 weeks
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort)
The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Measured: Baseline and 4 weeks
Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort)
The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Measured: Baseline and 8 weeks
Ocular Alignment at 4 Weeks
The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test.
Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).
Participants were classified according to whether they met the any of the following criteria at the 4-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.
Measured: 4 weeks
Ocular Alignment at 8 Weeks
The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 8 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 8 weeks will be reported by treatment group and compared using Barnard's exact test.
Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).
Participants were classified according to whether they met the any of the following criteria at the 8-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.
Measured: 8 weeks
Distribution of Diplopia Frequency at 4 Weeks (Participant-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Measured: 4 weeks
Distribution of Diplopia Frequency at 8 Weeks (Participant-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Measured: 8 weeks
Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.
Measured: 4 weeks
Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.
Measured: 8 weeks
Distribution of Diplopia Frequency at 4 Weeks (Parent-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks.
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Measured: 4 weeks
Distribution of Diplopia Frequency at 8 Weeks (Parent-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks.
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Measured: 8 weeks
Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.
Measured: 4 weeks
Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.
Measured: 8 weeks
Frequency of Adverse Symptoms (Symptom Survey)
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Measured: 4 weeks
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Measured: 8 weeks
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Measured: 4 weeks
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 8-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Measured: 8 weeks
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort)
The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Measured: Baseline and 4 weeks
Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort)
The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start2 Mar 2017
- Primary completion20 Apr 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Ruth Manny, OD, PhD, Study chair, University of Houston College of OptometryJonathan Holmes, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983552
- Sponsor's protocol ID
- ATS20
- Other IDs
- 2U10EY011751
- Acronym
- ATS20
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2016
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
Publications
Pediatric Eye Disease Investigator Group; Holmes JM, Manny RE, Lazar EL, Birch EE, Kelly KR, Summers AI, Martinson SR, Raghuram A, Colburn JD, Law C, Marsh JD, Bitner DP, Kraker RT, Wallace DK. A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years. Ophthalmology. 2019 Mar;126(3):456-466. doi: 10.1016/j.ophtha.2018.10.032. Epub 2018 Oct 22.
PubMed 30352226Manny RE, Holmes JM, Kraker RT, Li Z, Waters AL, Kelly KR, Kong L, Crouch ER, Lorenzana IJ, Alkharashi MS, Galvin JA, Rice ML, Melia BM, Cotter SA; Pediatric Eye Disease Investigator Group. A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years. Optom Vis Sci. 2022 Mar 1;99(3):213-227. doi: 10.1097/OPX.0000000000001867.
PubMed 35086119
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binocular Dig Rush Game Treatment for Amblyopia
- ClinicalTrials.gov ID
- NCT02983552
- Acronym / sponsor ID
- ATS20 / ATS20
- Conditions
- Amblyopia
- Keywords
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Posted 11 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.
Detailed description
The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binocular Computer Game Treatment | Experimental | Other: iPad®Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required) |
| Continued Spectacle Correction | Active comparator | Other: Spectacle correctionContinued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (40 listed)
- Age 4 to <13 years
- Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
- No amblyopia treatment other than optical correction in the past 2 weeks (patching, atropine, Bangerter, vision therapy, binocular treatment)
- Requirements for required refractive error correction (based on a cycloplegic refraction completed within the last 7 months):
- NOTE: Subjects with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.
Key exclusion criteria (8 listed)
- Prism in the spectacle correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).
- Myopia greater than -6.00D spherical equivalent in either eye.
- Previous intraocular or refractive surgery.
- Any treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy or previous binocular treatment) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks prior to enrollment.
- Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above VA criteria are met).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPad®Binocular therapy using a Dig Rush application on an iPad® | Other | Binocular Computer Game Treatment |
| Spectacle correctionSpectacle correction for all waking hours, 7 days per week | Other | Continued Spectacle Correction |
Primary outcome
Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort
Time frame: Baseline and 4 weeks
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)
Time frame: 4 weeks
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort
Time frame: Baseline and 8 weeks
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)
Time frame: 8 weeks
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort
Time frame: baseline and 4 weeks
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)
Time frame: 4 weeks
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort
Time frame: Baseline and 8 weeks
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)
Time frame: 8 weeks
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Primary Outcome Measure (Older Cohort) Stratified by Sex
Time frame: 4 Weeks
NIH-required analysis, stratified by sex. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Primary Outcome Measure (Older Cohort) Stratified by Race/Ethnicity
Time frame: 4 Weeks
NIH-required analysis, stratified by race/ethnicity. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Primary Outcome Measure (Younger Cohort) Stratified by Sex
Time frame: 4 Weeks
NIH-required analysis, stratified by sex. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Primary Outcome Measure (Younger Cohort) Stratified by Race/Ethnicity
Time frame: 4 Weeks
NIH-required analysis, stratified by race/ethnicity. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
32 secondary outcomes
VA Improvement at 4 Weeks Defined as a Binary Outcome
Time frame: At 4 weeks
VA Improvement at 8 Weeks Defined as a Binary Outcome
Time frame: At 8 weeks
Distribution of Stereoacuity Scores at 4 Weeks
Time frame: 4 weeks
Distribution of Change in Stereoacuity Scores From Baseline
Time frame: 4 weeks
Distribution of Stereoacuity Scores at 8 Weeks
Time frame: 8 weeks
Distribution of Change in Stereoacuity Scores From Baseline
Time frame: 8 weeks
Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
Time frame: 4 weeks
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
Time frame: 4 weeks
Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
Time frame: 8 weeks
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
Time frame: 8 weeks
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast
Time frame: 4 weeks
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast
Time frame: 8 weeks
Treatment Compliance With Spectacle Wear
Time frame: 4 weeks
Treatment Compliance With Spectacle Wear
Time frame: 8 weeks
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort)
Time frame: Baseline and 4 weeks
Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort)
Time frame: Baseline and 8 weeks
Ocular Alignment at 4 Weeks
Time frame: 4 weeks
Ocular Alignment at 8 Weeks
Time frame: 8 weeks
Distribution of Diplopia Frequency at 4 Weeks (Participant-reported)
Time frame: 4 weeks
Distribution of Diplopia Frequency at 8 Weeks (Participant-reported)
Time frame: 8 weeks
Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported)
Time frame: 4 weeks
Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported)
Time frame: 8 weeks
Distribution of Diplopia Frequency at 4 Weeks (Parent-reported)
Time frame: 4 weeks
Distribution of Diplopia Frequency at 8 Weeks (Parent-reported)
Time frame: 8 weeks
Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported)
Time frame: 4 weeks
Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported)
Time frame: 8 weeks
Frequency of Adverse Symptoms (Symptom Survey)
Time frame: 4 weeks
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks
Time frame: 8 weeks
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks
Time frame: 4 weeks
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks
Time frame: 8 weeks
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort)
Time frame: Baseline and 4 weeks
Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort)
Time frame: baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30352226Pediatric Eye Disease Investigator Group; Holmes JM, Manny RE, Lazar EL, Birch EE, Kelly KR, Summers AI, Martinson SR, Raghuram A, Colburn JD, Law C, Marsh JD, Bitner DP, Kraker RT, Wallace DK. A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years. Ophthalmology. 2019 Mar;126(3):456-466. doi: 10.1016/j.ophtha.2018.10.032. Epub 2018 Oct 22.
- Derived from this study: PubMed 35086119Manny RE, Holmes JM, Kraker RT, Li Z, Waters AL, Kelly KR, Kong L, Crouch ER, Lorenzana IJ, Alkharashi MS, Galvin JA, Rice ML, Melia BM, Cotter SA; Pediatric Eye Disease Investigator Group. A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years. Optom Vis Sci. 2022 Mar 1;99(3):213-227. doi: 10.1097/OPX.0000000000001867.
- Individual participant dataSharing planned: Yes. In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Manny, OD, PhD study chair
University of Houston College of Optometry
Jonathan Holmes, MD study chair
Mayo Clinic
62 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPad® and Spectacle correction in people with Amblyopia, run by Jaeb Center for Health Research at 62 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort (time frame: Baseline and 4 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02983552, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.