Binocular Dig Rush Game Treatment for Amblyopia
ATS20
2 other identifiers
interventional
320
2 countries
62
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2016
CompletedFirst Posted
Study publicly available on registry
December 6, 2016
CompletedStudy Start
First participant enrolled
March 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2020
CompletedResults Posted
Study results publicly available
June 11, 2021
CompletedJune 11, 2021
June 1, 2021
3.1 years
November 16, 2016
December 17, 2020
June 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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.
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.
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.
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.
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.
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.
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.
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.
8 weeks
Secondary Outcomes (32)
VA Improvement at 4 Weeks Defined as a Binary Outcome
At 4 weeks
VA Improvement at 8 Weeks Defined as a Binary Outcome
At 8 weeks
Distribution of Stereoacuity Scores at 4 Weeks
4 weeks
Distribution of Change in Stereoacuity Scores From Baseline
4 weeks
Distribution of Stereoacuity Scores at 8 Weeks
8 weeks
- +27 more secondary outcomes
Other Outcomes (1)
Exploratory Analysis: Subgroup VA Change Analysis at 4 Weeks
Baseline and 4 weeks
Study Arms (2)
Binocular Computer Game Treatment
EXPERIMENTALBinocular 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 COMPARATORContinued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.
Interventions
Binocular therapy using a Dig Rush application on an iPad®
Spectacle correction for all waking hours, 7 days per week
Eligibility Criteria
You may qualify if:
- 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:
- ≥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
- +25 more criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jaeb Center for Health Researchlead
- Pediatric Eye Disease Investigator Groupcollaborator
- National Eye Institute (NEI)collaborator
Study Sites (62)
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, 35294, United States
Midwestern University Eye Institute
Glendale, Arizona, 85308, United States
University Eye Center at Ketchum Health
Anaheim, California, 92807, United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, 92354, United States
Saddleback Eye Medical Associates
Mission Viejo, California, 92691, United States
Western University College of Optometry
Pomona, California, 91766, United States
Yale University
New Haven, Connecticut, 06511, United States
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, 33382, United States
University of Florida Shands Hospital
Gainesville, Florida, 32608, United States
The Emory Eye Center
Atlanta, Georgia, 30322, United States
St Luke's Hospital
Boise, Idaho, 83702, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Illinois College of Optometry
Chicago, Illinois, 60616, United States
Ticho Eye Associates
Chicago Ridge, Illinois, 60415, United States
Progressive Eye Care
Lisle, Illinois, 60532, United States
Advanced Vision Center
Schaumburg, Illinois, 60194, United States
Pediatric Eye Associates
Wilmette, Illinois, 60091, United States
Indiana School of Optometry
Bloomington, Indiana, 47405, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204-5809, United States
Wilmer Eye Institute
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan, 49307, United States
Helen DeVos Children's Hospital Pediatric Ophthalmology
Grand Rapids, Michigan, 49503, United States
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, 49546, United States
University of Minnesota-Minnesota Lions Children's Eye Clinic
Minneapolis, Minnesota, 55454, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
Saint Louis University Institute
St Louis, Missouri, 63103, United States
St. Louis Children's Hospital Eye Center
St Louis, Missouri, 63110, United States
U of MO St. Louis College of Optometry
St Louis, Missouri, 63121, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68114, United States
Concord Ophthalmologic Associates
Concord, New Hampshire, 03301, United States
Michael F. Gallaway, O.D., P.C.
Marlton, New Jersey, 08053, United States
State University of New York, College of Optometry
New York, New York, 10036, United States
University of North Carolina
Chapel Hill, North Carolina, 27599-7040, United States
Duke University Eye Center
Durham, North Carolina, 27710, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio, 43205, United States
The Ohio State University College of Optometry
Columbus, Ohio, 43210-1280, United States
Eye Care Associates, Inc.
Poland, Ohio, 44514, United States
Dean A. McGee Eye Institute, University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Pacific University College of Optometry
Portland, Oregon, 97205, United States
OHSU Casey Eye Institute
Portland, Oregon, 97239, United States
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, 16501, United States
Conestoga Eye
Lancaster, Pennsylvania, 17601, United States
Pediatric Eye Specialists
Chattanooga, Tennessee, 37421, United States
Southern College of Optometry
Memphis, Tennessee, 38104, United States
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas, 77030, United States
University of Houston College of Optometry
Houston, Texas, 77204, United States
Texas Tech University Health Science Center
Lubbock, Texas, 79430, United States
San Antonio Eye Center
San Antonio, Texas, 78215, United States
Houston Eye Associates
The Woodlands, Texas, 77381, United States
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502, United States
Seattle Children's Hospital, University of Washington
Seattle, Washington, 98105, United States
Northwest Pediatric Ophthalmology, P.S.
Spokane, Washington, 99202, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
Marshall University
Huntington, West Virginia, 25755, United States
University of Wisconsin, University Station
Madison, Wisconsin, 53705, United States
Snowy Range Vision Center
Laramie, Wyoming, 82070, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
Related Publications (2)
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.
PMID: 30352226BACKGROUNDManny 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.
PMID: 35086119DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Raymond Kraker, M.S.P.H., Director of PEDIG Coordinating Center
- Organization
- Jaeb Center for Health Research
Study Officials
- STUDY CHAIR
Ruth Manny, OD, PhD
University of Houston College of Optometry
- STUDY CHAIR
Jonathan Holmes, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2016
First Posted
December 6, 2016
Study Start
March 2, 2017
Primary Completion
April 20, 2020
Study Completion
July 10, 2020
Last Updated
June 11, 2021
Results First Posted
June 11, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be made available after publication of each primary manuscript.
- Access Criteria
- Users accessing the data must enter an email address.
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.