NCT06380517

Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.

Detailed description

Participants eligible for the study will be randomly allocated (1:1) to receive either dichoptic treatment while wearing the Luminopia headset or patching treatment of the fellow eye for amblyopia with clinical assessments at 13, and 26-weeks post-randomization. At the 26-week primary outcome visit, participants who were randomly assigned to receive patching treatment with an IOD of 1 logMAR line or more, will be offered Luminopia dichoptic therapy and if they accept, followed forward with visits at 39- and 52-weeks post-randomization. The study will end for all other participants.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	Luminopia	dichoptic movies/shows shown through a virtual reality headset
OTHER	Eye Patch	Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-07-01
• Completion: 2028-01-01
• First posted: 2024-04-24
• Last updated: 2026-02-11

Locations

73 sites across 1 country: United States

Regulatory

• FDA-regulated device study