Binocular Dig Rush Game Treatment for Amblyopia

Completed · Not applicable

Conditions studied: Amblyopia

In brief

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.

Key facts

Study ID: NCT02983552
Run by: Jaeb Center for Health Research
People needed: 320
Starts: 2017-03-02
Expected to finish: 2020-07-10
Last updated by the study team: 2026-07-09

Who can join

Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

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
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:

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)

Where it is running

Midwestern University Eye Institute — Glendale, Arizona, United States
University Eye Center at Ketchum Health — Anaheim, California, United States
Loma Linda University Health Care, Dept. of Ophthalmology — Loma Linda, California, United States
Saddleback Eye Medical Associates — Mission Viejo, California, United States
Western University College of Optometry — Pomona, California, United States
Yale University — New Haven, Connecticut, United States
Nova Southeastern University College of Optometry, The Eye Institute — Fort Lauderdale, Florida, United States
University of Florida Shands Hospital — Gainesville, Florida, United States
The Emory Eye Center — Atlanta, Georgia, United States
St Luke's Hospital — Boise, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
Illinois College of Optometry — Chicago, Illinois, United States
Ticho Eye Associates — Chicago Ridge, Illinois, United States
Progressive Eye Care — Lisle, Illinois, United States
Advanced Vision Center — Schaumburg, Illinois, United States
Pediatric Eye Associates — Wilmette, Illinois, United States
Indiana School of Optometry — Bloomington, Indiana, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
Wolfe Eye Clinic — West Des Moines, Iowa, United States
Greater Baltimore Medical Center — Baltimore, Maryland, United States
Wilmer Eye Institute — Baltimore, Maryland, United States
Boston Children's Hospital — Boston, Massachusetts, United States
Michigan College of Optometry at Ferris State Univ — Big Rapids, Michigan, United States
Helen DeVos Children's Hospital Pediatric Ophthalmology — Grand Rapids, Michigan, United States
UAB Pediatric Eye Care; Birmingham Health Care — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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