A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Jaeb Center for Health Research
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.
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.
Eligibility
- Age range
- 4–7 years
- Sex
- All
- Healthy volunteers
- No
At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study. 1. Age 4 to 7 years. 2. Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV VA protocol on a study-approved device displaying single surrounded optotypes, as follows: 1. VA in the amblyopic eye 20/40 to 20/200 inclusive. 2. Age-normal VA in the fellow eye:44,45 • 4 years: 20/40 or better; 5-6 years: 20/32 or better; 7 years: 20/25 or better 3. Interocular difference ≥ 3 logMAR…
Interventions
- DeviceLuminopia
dichoptic movies/shows shown through a virtual reality headset
- OtherEye Patch
Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye
Locations (73)
- UAB Pediatric Eye Care; Birmingham Health CareBirmingham, Alabama
- Midwestern University Eye InstituteGlendale, Arizona
- Phoenix Children's Medical Group - OphthalmologyScottsdale, Arizona
- University of ArizonaTucson, Arizona
- Arkansas ChildrensLittle Rock, Arkansas
- McFarland Eye Care CenterLittle Rock, Arkansas