NCT06429280 Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
| NCT ID | NCT06429280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Luminopia |
| Condition | Amblyopia |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Have a diagnosis of amblyopia * Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks Exclusion Criteria: -Have participated in prior Luminopia clinical trials
Frequently Asked Questions
Who can join the NCT06429280 clinical trial?
This trial is open to participants of all sexes, studying Amblyopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06429280 currently recruiting?
Yes, NCT06429280 is actively recruiting participants. Visit ClinicalTrials.gov or contact Luminopia to inquire about joining.
Where is the NCT06429280 trial being conducted?
This trial is being conducted at San Ramon, United States, Santa Barbara, United States, Crestview, United States, Gainsville, United States and 9 additional locations.
Who is sponsoring the NCT06429280 clinical trial?
NCT06429280 is sponsored by Luminopia. The trial plans to enroll 500 participants.