Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
- Conditions
- Amblyopia
- Registration Number
- NCT06380517
- Lead Sponsor
- Jaeb Center for Health Research
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 238
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in amblyopic eye logMAR distance VA between randomization and 26 weeks 26 Weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (63)
UAB Pediatric Eye Care; Birmingham Health Care
🇺🇸Birmingham, Alabama, United States
Midwestern University Eye Institute
🇺🇸Glendale, 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
Jules Stein Eye Institute at the University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Scroll for more (53 remaining)UAB Pediatric Eye Care; Birmingham Health Care🇺🇸Birmingham, Alabama, United StatesKristine Hopkins, O.D.Principal Investigator