Recruiting

Amblyopia Treatment

Sponsor:

Retina Foundation of the Southwest

Code:

NCT03288948

Conditions

Amblyopia

Eligibility Criteria

Sex: All

Age: 4 - 10

Healthy Volunteers: Not accepted

Interventions

Binocular games for treatment of amblyopia

Study Details

Brief summary:

To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.

Conditions

Amblyopia

Study ID

NCT03288948

Start date

Aug 31, 2017

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 10

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age 4-10 y
  • male and female
  • strabismic, anisometropic, or combined mechanism amblyopia
  • amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR
  • fellow eye best-corrected visual acuity ≤0.1 logMAR
  • interocular visual acuity difference ≥0.3 logMAR
  • wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2 visits

  • 4 weeks apart.
  • child's ophthalmologist and family must be willing to forgo patching treatment during the 12-week study period
  • parent's informed consent
  • child must demonstrate understanding and ability to play binocular games

Exclusion Criteria:

  • prematurity ≥8 weeks
  • coexisting ocular or systemic disease
  • developmental delay
  • strabismus >5pd
  • any binocular amblyopia treatment in the past 3 months

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Contrast Increment

experimental: Reduced Contrast Increment

experimental: No Contrast Increment

Interventions

Binocular games for treatment of amblyopia

playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye

Primary outcome measure

  • Change in visual acuity of the amblyopic eye [ Time Frame: baseline vs 8 weeks ]

Central Contacts and Locations

Central contacts

Reed Jost, MS

2143633911reedjost@retinafoundation.org

Krista Kelly, PhD

2143633911kkelly@rfsw.org

Locations

Retina Foundation of the Southwest

Recruiting

Dallas, Texas, United States, 75231

Contacts

Pediatric Laboratory

2143633911

Principal Investigator:

Eileen E Birch, PhD

More Information

Sponsor

Retina Foundation of the Southwest

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Retina Foundation of the Southwest on 2026-02-23.