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Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
NCT06429280 · View on ClinicalTrials.gov ↗
Study Summary
Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. In addition to reduced visual acuity, amblyopic patients may also have measurable dysfunction of accommodation, fixation, binocularity, vergence, reading fluency, depth perception, and contrast sensitivity. For the first time since the incorporation of atropine penalization into amblyopia management, physicians can now offer Luminopia, an FDA-approved dual action dichoptic treatment, to patients with amblyopia. Since the product became commercially available in November 2022, the number of patients on Luminopia therapy continues to grow. This presents a unique opportunity to gather real world evidence from a large number of patients, representative of how ophthalmologists and optometrists are applying this novel treatment in the real world. A registry of the clinical data associated with Luminopia treatment, with IRB oversight, will provide answers to key scientific questions using a large dataset.
Conditions Studied
Interventions
- DEVICE N/A this is an observational study of Standard of Care
Study Locations (13)
Florida
- Okaloosa Ophthalmology — Crestview
- Family Focus Eye Care — Gainsville
- Eye Physicians of Central Florida — Maitland
California
- UCSF Benioff Children's Physicians — San Ramon
- Sansum Clinic — Santa Barbara
Georgia
- Children's Eye Institute of Savannah — Savannah
Hawaii
- Honolulu Eye Clinic — Honolulu
Illinois
- Lurie Children's Hospital — Chicago
Indiana
- Riley Children's Hospital at IU Health — Indianapolis
Nevada
- Nevada Eye Physicians — Las Vegas
New Hampshire
- Concord Eye Center — Concord
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-09-01 |
| Est. Completion | 2026-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06429280
The ClinicalTrials.gov registry entry for NCT06429280 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Luminopia, which has 1 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 1 intervention — of which N/A this is an observational study of Standard of Care 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: NCT06429280 reports 13 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Georgia. 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 NCT06429280 about?
NCT06429280 is a clinical study titled "Clinical Data Registry of Amblyopia Patients on Luminopia Treatment". Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. In addition to reduced ...
What is the current status of trial NCT06429280?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2023-09-01. Estimated completion is 2026-12-31.
What conditions does trial NCT06429280 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 NCT06429280?
The interventions under investigation include: N/A this is an observational study of Standard of Care (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06429280?
This trial is sponsored by Luminopia, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06429280 being conducted?
This trial has 13 study locations across California, Florida, Georgia, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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