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| Name | Class |
|---|---|
| The Vision Research and Assessment Institute (VRAI) | UNKNOWN |
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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.
The VRAI is a state-of-the-art research institute specifically for patients with low or very low vision due to diseases of the retina of the eye. The Institute is staffed by highly experienced Low Vision specialists and provides a comfortable, familiar environment for patient testing.
The study is a non-interventional prospective cohort study of up to 40 patients for each disease condition (Retinitis Pigmentosa, Choroideremia, Stargardt Macular Dystrophy, Geographic Atrophy from Age-related Macular Degeneration, X-linked Retinoschisis or other retinal dystrophies ).
Patients are scheduled for an initial visit where they are tested on a series of efficacy tests. Thereafter, patients will be invited to attend for a further visit up to two weeks and then periodically for up to one year. The objectives of the study are to evaluate how well patients use their vision, how the tests relate to activities of daily living, establish clinical meaningfulness, assess the impact of disease progression and the precision and accuracy of each test in the context of their eye condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retinitis Pigmentosa | Up to 40 patients with Retinitis Pigmentosa | ||
| Choroideremia | Up to 40 patients with Choroideremia | ||
| Stargardt Macular Dystrophy (Stargardt Disease) | Up to 40 patients with Stargardt Macular Dystrophy also known as Stargardt Disease | ||
| Geographic Atrophy from Age-related Macular Degeneration | Up to 40 patients with Geographic Atrophy from Age-related Macular Degeneration | ||
| X-linked Retinoschisis | Up to 40 patients with X-linked Retinoschisis | ||
| Other Retinal Dystrophies | Up to 40 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 20/70 - 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-retest reliability on the same visit or on two different testing sessions on different days including determination of significant learning effects or 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, choroideremia, or Stargardt macular dystrophy (also known as Stargardt disease), geographic atrophy from age-related macular degeneration, X-linked retinoschisis or other retinal dystrophies
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shawn Yu, OD | 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 | 92612 | 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 |
| D015794 | Choroideremia |
| D000080362 | Stargardt Disease |
| 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 |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D008268 | Macular Degeneration |
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