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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retinitis Pigmentosa | Up to 25 patients with Retinitis Pigmentosa | ||
| Other Retinal Dystrophies | Up to 25 patients with Other Retinal Dystrophies |
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| Measure | Description | Time Frame |
|---|---|---|
| Operational feasibility of testing moderate to profound vision impaired patients with various retinal dystrophies on a battery of visual assessments | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification) | 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with moderate to profound vision impairment diagnosed with retinitis pigmentosa or other retinal dystrophies.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reem Jaber, MS, CGC | Contact | 949-264-3793 | info@vr-ai.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Research and Assessment Institute | Recruiting | Irvine | California | 92614 | United States |
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| To quantify assessor-based measurement properties of each test modality (for the purposes of endpoint qualification) |
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. |
| 2 years |
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D000080362 | Stargardt Disease |
| D041441 | Retinoschisis |
| D058499 | Retinal Dystrophies |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008268 | Macular Degeneration |
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