A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Jaeb Center for Health Research
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.
Eligibility
- Age range
- 8–12 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 8 to \<13 years. 2. VA, measured in each eye without cycloplegia in current refractive correction (if applicable) using the E-ETDRS 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 (33 to 72 letters with E-ETDRS). 2. VA in the fellow eye 20/25 or better (≥ 78 letters with E-ETDRS). 3. Interocular difference ≥ 3 logMAR lines (≥ 15 letters) i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA). 3. Amblyopia associated with strabismus, anisometrop…
Interventions
- DeviceVivid Vision
dichoptic video games played through a virtual reality headset
- DeviceLuminopia
dichoptic movies/shows shown through a virtual reality headset
- DeviceOptical Correction
Glasses prescribed at investigator discretion
Locations (58)
- 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