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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
238
Change in amblyopic eye logMAR distance VA between randomization and 26 weeks
Time frame: 26 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, United States
RECRUITINGMidwestern University Eye Institute
Glendale, Arizona, United States
RECRUITINGPhoenix Children's Medical Group - Ophthalmology
Scottsdale, Arizona, United States
RECRUITINGUniversity of Arizona
Tucson, Arizona, United States
RECRUITINGArkansas Childrens
Little Rock, Arkansas, United States
RECRUITINGMcFarland Eye Care Center
Little Rock, Arkansas, United States
RECRUITINGUniv. of California- Berkeley
Berkeley, California, United States
RECRUITINGSouthern California College of Optometry
Fullerton, California, United States
RECRUITINGUniv of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, United States
RECRUITINGChildren's Hospital of Los Angeles (CHLA)
Los Angeles, California, United States
RECRUITING...and 63 more locations