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.
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
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
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
Cohort
Prospective
Not listed
6
Trial groupsSee each trial group below.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
Ray Therapeutics, Inc.
Lead sponsor
The Vision Research and Assessment Institute (VRAI)
Collaborator
