Binocular Amblyopia Treatment

Amblyopia Clinical Trial

Official title: Binocular Amblyopia Treatment

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Amblyopia

• NCT number: NCT03288948
• Study type: Interventional
• Source: Retina Foundation of the Southwest
• Contact: Reed Jost, MS
• Phone: 2143633911
• Email: reedjost@retinafoundation.org
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2017
• Completion date: June 30, 2025