A Phase 3 interventional study of Luminopia and Eye Patch in Amblyopia, sponsored by Jaeb Center for Health Research. Recruiting at 73 sites in United States. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Jaeb Center for Health Research · Phase 3, Interventional, and Treatment
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.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 238 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.
At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study.
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:
Age-normal VA in the fellow eye:44,45
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: 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):
Individuals meeting any of the following criteria will be excluded from study participation.
watching 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 optical correction, if needed.
Device: Luminopia
patching of the fellow eye 2 hours per day (treatment time can be split into shorter sessions totaling 2 hours each day) 7 days per week with optical correction, if needed.
Other: Eye Patch
dichoptic movies/shows shown through a virtual reality headset
Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye
Change in amblyopic eye logMAR distance VA between randomization and 26 weeks
Time frame: 26 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
Started Jul 2024 (actual). Primary completion is estimated for Mar 2028, 43 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 2, 2026: primary completion Jul 2027 → Mar 2028 and completion Jan 2028 → Aug 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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