Assessing vision measurement methods for patients with retinal degeneration
Observational, Non-Interventional Study to Determine the Operational Feasibility and Measurement Properties of Endpoints in Patients with Retinal Degeneration
This study is testing different ways to measure vision in people with retinal degeneration to see how their eyesight affects daily life and how it changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ray Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT06375239 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on evaluating the operational feasibility and measurement properties of efficacy endpoints for patients suffering from various retinal degenerations, including Retinitis Pigmentosa and Stargardt Disease. Conducted at the Vision Research and Assessment Institute, the study involves a prospective cohort of up to 40 patients for each condition, who will undergo a series of vision tests over a year. The aim is to understand how well patients utilize their vision in daily activities and to assess the impact of disease progression on their visual capabilities.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with specific retinal degenerations and who have a certain level of visual acuity.
Not a fit: Patients with cognitive impairments or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for assessing vision in patients with retinal degeneration, enhancing their quality of life.
How similar studies have performed: Other studies have shown promise in assessing visual function in similar patient populations, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of bilateral retinitis pigmentosa, choroideremia, Stargardt macular dystrophy, geographic atrophy from age-related macular degeneration, X-linked retinoschisis or other retinal dystrophies confirmed from previous eye examination records * Best-corrected visual acuity between 20/70 and HM in at least one eye as tested with clinic-based visual acuity method * Reasonably fluent in English Exclusion Criteria: * Cognitive impairment, memory loss or dementia sufficient in severity to preclude informed consent or in the opinion of the investigator would prevent satisfactory completion of some or all of the testing. * Any circumstance that in the opinion of the investigator, would interfere with participation in, or compliance with the study protocol * Current pregnancy as reported by patient
Where this trial is running
Irvine, California
- Vision Research and Assessment Institute — Irvine, California, United States (Recruiting)
Study contacts
- Study coordinator: Shawn Yu, OD
- Email: info@vr-ai.com
- Phone: 949-264-3793
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.