Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
NCT06380517 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Luminopia
- OTHER Eye Patch
Study Locations (20)
California
- Univ. of California- Berkeley — Berkeley
- Southern California College of Optometry — Fullerton
- Univ of California, Irvine- Gavin Herbert Eye Institute — Irvine
- Children's Hospital of Los Angeles (CHLA) — Los Angeles
- Jules Stein Eye Institute at the University of California, Los Angeles — Los Angeles
- Stanford University — Palo Alto
- Western University College of Optometry — Pomona
- University of California, Davis — Sacramento
- Rady Children's Hospital - San Diego Dept of Ophthalmology — San Diego
- University of California San Francisco Department of Ophthalmology — San Francisco
Arizona
- Midwestern University Eye Institute — Glendale
- Phoenix Children's Medical Group - Ophthalmology — Scottsdale
- University of Arizona — Tucson
Arkansas
- Arkansas Childrens — Little Rock
- McFarland Eye Care Center — Little Rock
Alabama
- UAB Pediatric Eye Care; Birmingham Health Care — Birmingham
Connecticut
- Yale University — New Haven
Florida
- University of South Florida (USF) Eye — Tampa
Georgia
- The Emory Eye Center — Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06380517
The ClinicalTrials.gov registry entry for NCT06380517 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Amblyopia appearing as the primary indexed condition, and to 2 interventions — of which Luminopia is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06380517 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Arizona, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06380517 about?
NCT06380517 is a clinical study titled "Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age". 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 rando...
What is the current status of trial NCT06380517?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 238 participants. The study started on 2024-07-01. Estimated completion is 2028-01-01.
What conditions does trial NCT06380517 study?
This clinical trial studies the following conditions: Amblyopia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06380517?
The interventions under investigation include: Luminopia (DEVICE), Eye Patch (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06380517?
This trial is sponsored by Jaeb Center for Health Research, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06380517 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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