RecruitingAmblyopia

Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

Eligible age

8–12 yrs

Accepts

All genders

Locations

26 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: Jaeb Center for Health Research

You may qualify if…

✓ 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, anisometropia, or both (previously treated or untreated).
✓ 1. Criteria for strabismic amblyopia: At least one of the following must be met:
✓ Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \<=5 prism diopters (∆) by SPCT at distance and near fixation.

You may not qualify if…

✕ 1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)
✕ 2. Prism greater than a total of 8 diopters horizontal and 1 diopter vertical in the refractive correction at time of enrollment.
✕ 3. Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).
✕ 4. Myopia greater than -6.00D spherical equivalent in either eye.
✕ 5. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted).
✕ 6. Diplopia more than once per week over the last week prior to enrollment by parental report.
✕ 7. History of light-induced seizures.
✕ 8. Known simulator sickness.