Geographic Atrophy From Age-related Macular Degeneration, Retinal Dystrophies, Retinitis Pigmentosa, Stargardt Disease, Stargardt Macular Dystrophy, X-linked Retinoschisis
Conditions
Brief summary
The Vision Research and Assessment Institute (VRAI) was established with the purpose of serving as a testing facility for efficacy endpoints for patients with Low Vision. The mission of the VRAI is to enable the highest quality, standardized efficacy testing of patients with visual impairment. The VRAI facilitates the development and refinement of existing endpoints specifically for testing patients with Low Vision.
Detailed description
This observational, non-interventional study is designed to assess both the operational feasibility and the measurement properties of selected visual function assessments in this population. The study will emphasize outcome measures that are sensitive to peripheral visual function and that reflect real-world functional abilities, including spatial orientation, mobility, and wayfinding.
Interventions
None listed
Sponsors
Ray Therapeutics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of bilateral retinitis pigmentosa (RP) or other retinal dystrophies impacting peripheral vision as confirmed from previous eye examination records * Best-corrected visual acuity between 20/200 to HM in at least one eye. * Reasonably fluent in English or Spanish
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operational feasibility of testing moderate to profound vision impaired patients with various retinal dystrophies on a battery of visual assessments | 3 months | Determining how many patients in the visual range 20/200 - HM (depending upon indication) can perform specific tests of visual function with a measurable score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification) | 2 years | Test-rest reliability on the same visit or on two different testing sessions on different days including determination of significant learning effects of other scoring variables that impact variability. |
| To quantify assessor-based measurement properties of each test modality (for the purposes of endpoint qualification) | 2 years | Intra- and inter-grader variability for scoring of tests by test graders/raters. Assessments incorporating independent graders/raters will be assessed for within session and across session scoring reliability to ensure consistent methods. |
Countries
United States
Contacts
CONTACTReem Jaber, MS, CGC
Outcome results
None listed