Enhanced treatment for amblyopia using binocular games
Binocular Amblyopia Treatment
This study is testing if playing special games for 8 weeks can help children aged 4-10 with amblyopia see better compared to the usual 4-week treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | Retina Foundation of the Southwest Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT03288948 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of new protocols for binocular amblyopia treatment, aiming to achieve better visual acuity recovery in children aged 4-10. It compares two alternative treatment protocols that extend the game treatment period beyond the traditional 4 weeks to an 8-week duration. The study involves an 8-week randomized controlled trial with three arms, assessing the outcomes of these new protocols against the standard 10% contrast-increment game protocol. Children who achieve certain visual acuity benchmarks will receive additional training to promote binocular vision.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-10 with strabismic, anisometropic, or combined mechanism amblyopia and specific visual acuity criteria.
Not a fit: Patients with coexisting ocular or systemic diseases, developmental delays, or those who have received binocular amblyopia treatment in the past 3 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve visual acuity and binocular vision in children with amblyopia.
How similar studies have performed: Previous studies have shown promise with contrast-rebalanced binocular treatments, but this specific approach is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dallas, Texas
- Retina Foundation of the Southwest — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Reed Jost, MS
- Email: reedjost@retinafoundation.org
- Phone: 2143633911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.