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NCT03288948NARecruiting

Binocular Amblyopia Treatment

Retina Foundation of the Southwest

Start Date

8/31/2017

Completion Date

12/31/2026

Summary

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

Detailed Description

To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same 10% per day contrast-increment that was designed for short-term intervention studies lasting 1-4 weeks; i.e., after 18 days of successful game play, both eyes viewed 100% contrast (no contrast-rebalancing).This study will investigate two alternative protocols designed to extend the game treatment period beyond 4 weeks to allow for more complete recovery of visual acuity. The new protocols will be compared with the original 10% contrast-increment game protocol in an 8-week 3-arm RCT to determine whether one or both of the new protocols is more effective than the current 10% increment. Based on pilot data, we expect about 40% of amblyopic children to achieve normal visual acuity in 8 weeks. In an effort to also promote recovery of binocular vision, children who attain ≤0.4 logMAR at 8 weeks will be enrolled in stereoacuity training at the 8-week visit for the next 4 weeks. Children with residual amblyopia (BCVA \>0.4 logMAR) at the 8-week visit will be provided with dichoptic movies for additional amblyopia treatment for another 4 weeks.

Eligibility Criteria

Age Range: 4 years to 10 years

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

Interventions

OTHER

Binocular games for treatment of amblyopia

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Conditions

Amblyopia

Locations

Retina Foundation of the Southwest

Dallas, Texas 75231

United States