Clinical Trial

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

Study acronym: ATS24
Recruiting Phase 3
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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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2024-07-23; most recent amendment 2026-02-09.
Status change: Not Yet Recruiting → Recruiting 2024-10-22
Trial Details
NCT Number NCT06524882
Lead Sponsor Jaeb Center for Health Research
Collaborators: National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
Conditions Amblyopia
Enrollment 252 participants
Start Date 2024-10-22
Primary Completion 2027-07-01 (estimated)
Study Completion 2027-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-11