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NCT06429280 · ClinicalTrials.gov registry record
Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
A clinical trial of Amblyopia, sponsored by Luminopia.
- Recruiting
- Registry status
- 500
- Enrollment target
- 13
- Study locations
NCT06429280 is a study of Amblyopia that is actively recruiting participants, run by Luminopia. The registered enrollment target is 500 participants, above the 145-participant average among 24 other Amblyopia trials with a reported enrollment target (245% higher). The trial reports 13 study locations across 10 states.
The verdict
NCT06429280, a study of Amblyopia, is actively recruiting participants, sponsored by Luminopia.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 13
- Study locations
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 145-participant average among 24 other Amblyopia trials with a reported enrollment target (245% higher). The listed sponsor is Luminopia, which has 3 total studies on file at ClinicalTrials.gov.
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.
NCT06429280 reports 13 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Georgia.
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.
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).
Who is sponsoring clinical trial NCT06429280?
This trial is sponsored by Luminopia, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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