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A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
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.
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.
Age
4 - 7 years
Sex
ALL
Healthy Volunteers
No
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, United States
Midwestern University Eye Institute
Glendale, Arizona, United States
Phoenix Children's Medical Group - Ophthalmology
Scottsdale, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Arkansas Childrens
Little Rock, Arkansas, United States
McFarland Eye Care Center
Little Rock, Arkansas, United States
Univ. of California- Berkeley
Berkeley, California, United States
Southern California College of Optometry
Fullerton, California, United States
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, United States
Children's Hospital of Los Angeles (CHLA)
Los Angeles, California, United States
Start Date
July 1, 2024
Primary Completion Date
July 1, 2027
Completion Date
January 1, 2028
Last Updated
February 11, 2026
238
ESTIMATED participants
Luminopia
DEVICE
Eye Patch
OTHER
Lead Sponsor
Jaeb Center for Health Research
Collaborators
NCT07417046
NCT04378790
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05440448