A Phase 3 interventional study of Vivid Vision and Luminopia in Amblyopia, sponsored by Jaeb Center for Health Research. Recruiting at 58 sites in United States. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Jaeb Center for Health Research · Phase 3, Interventional, and Treatment
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.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 252 is above the median of 60 across 137 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Jaeb Center for Health Research is the lead sponsor of 129 studies on the registry; 16 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).
Criteria for strabismic amblyopia: At least one of the following must be met:
Criteria for anisometropia: At least one of the following criteria must be met:
Criteria for combined-mechanism: Both of the following criteria must be met:
Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months:
NOTE: Children with cycloplegic refractive errors that do not fall within the requirements above for refractive correction may be given refractive correction at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.
NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles).
Spectacles/contact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:
Spectacles/contact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn:
For determining VA stability (non-improvement):
Exclusion Criteria:
dichoptic movies/shows wearing the Luminopia headset prescribed 1 hour per day (treatment time can be split into shorter sessions totaling 1 hour each day) 6 days a week with current optical correction if needed
Device: Luminopia
dichoptic games using the Vivid Vision headset, prescribed approximately 25 minutes per day (treatment time to complete the day's sessions can be split into shorter sessions totaling about 25 minutes each day) 6 days per week with current optical correction if needed
Device: Vivid Vision
continued full-time optical correction alone if needed
Device: Optical Correction
dichoptic video games played through a virtual reality headset
dichoptic movies/shows shown through a virtual reality headset
Glasses prescribed at investigator discretion
Change in amblyopic eye logMAR distance VA
between randomization and 18 weeks
Time frame: 18 Weeks
Functional Vision, Social, and Frustration/Worry quality of life domains as measured by the Pediatric Eye Questionnaire (PedEyeQ).
Questionnaire outcome
Time frame: 18 Weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be made available after publication.
Access criteria: Users accessing the data must enter an email address
Data sharing details ↗ · pedig.jaeb.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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