NCT06524882

Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization. At the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization. The study will end for all other participants at 18 weeks.

Conditions

• Amblyopia

Interventions

Type	Name	Description
DEVICE	Vivid Vision	dichoptic video games played through a virtual reality headset
DEVICE	Luminopia	dichoptic movies/shows shown through a virtual reality headset
DEVICE	Optical Correction	Glasses prescribed at investigator discretion

Timeline

• Start date: 2024-10-22
• Primary completion: 2027-07-01
• Completion: 2027-11-01
• First posted: 2024-07-29
• Last updated: 2026-02-11

Locations

58 sites across 1 country: United States