Actively Recruiting

Phase Not Applicable
Age: 4Years - 10Years
All Genders
ID03288948

Binocular Amblyopia Treatment Evaluating Enhanced Contrast Protocols in Children Ages 4 to 10 Years

Led by Retina Foundation of the Southwest · Updated on 2026-02-23

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Retina Foundation of the Southwest

Lead Sponsor

N

National Eye Institute (NEI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating enhanced binocular treatments for children aged 4 to 10 years with amblyopia, a condition that affects vision in one eye. The study compares new treatment protocols designed to extend therapy beyond the usual 4-week period to see if they result in a more complete and stable recovery of vision. This research aims to determine if these alternative methods improve visual acuity and binocular vision compared to the original treatment approach. Participants will play binocular games on a tablet for one hour per day, five days a week, using different contrast increment protocols. The study is a randomized trial with three groups: the original 10% contrast increment, a reduced contrast increment, and no contrast increment. After 8 weeks, children who achieve normal visual acuity will begin stereoacuity training for 4 weeks, while those with remaining vision issues will receive dichoptic movie treatment for an additional 4 weeks. During the 12-week study, children will be assessed at various time points to measure changes in visual acuity, stereoacuity, and suppression. Visual acuity of the amblyopic eye is the primary outcome measured at baseline and 8 weeks. Participants and their families must agree to avoid patching treatments during the study. The research includes regular monitoring and requires children to be able to play the binocular games to participate.

CONDITIONS

Brief Title

Binocular Amblyopia Treatment

Who Can Participate

Age: 4Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 4 and 10 years
  • Male and female children
  • Diagnosed with strabismic, anisometropic, or combined mechanism amblyopia
  • Amblyopic eye best-corrected visual acuity between 0.3 and 0.8 logMAR
  • Fellow eye best-corrected visual acuity 0.1 logMAR or better
  • Interocular visual acuity difference of 0.3 logMAR or greater
  • Wearing glasses if needed for at least 8 weeks or no change in visual acuity with glasses at two visits 4 weeks apart
  • Child's ophthalmologist and family agree to avoid patching treatment during the 12-week study
  • Parent's informed consent
  • Child able to understand and play binocular games
Not Eligible

You will not qualify if you...

  • Prematurity of 8 weeks or more
  • Coexisting ocular or systemic disease
  • Developmental delay
  • Strabismus greater than 5 prism diopters
  • Any binocular amblyopia treatment in the past 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants play binocular games on a tablet for amblyopia treatment, 1 hour per day, 5 days per week with varying contrast protocols over 8 weeks.

Weekly visits for assessments during treatment

Treatment Extension

Duration - 4 weeks

Participants who achieve normal visual acuity continue stereoacuity training for 4 additional weeks, while those with residual amblyopia receive dichoptic movie treatment for 4 additional weeks.

1 to 2 visits depending on treatment response

Trial Site Locations

Total: 1 location

1

Retina Foundation of the Southwest

Dallas, Texas, United States, 75231

Actively Recruiting

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Research Team

R

Reed Jost, MS

K

Krista Kelly, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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