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Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging — RBI  

Amblyopia Clinical Trial

Official title:
Deploying Retinal Birefringence Imaging in to the Clinic for Pediatric Vision Screening

Clinical Trial Summary

The purpose of this project is to compare the accuracy of two products at detecting amblyopia and strabismus in children. The devices will be Rebiscan's "blinq" (Pediatric Vision Scanner; PVS) and Rebiscan's RBI (Retinal Birefringence Imager).

Clinical Trial Description

Rebiscan is proposing a two-cohort study. The first cohort will include a population enriched for pathology in amblyopia to best assess device sensitivity, while a second cohort will be based in a primary care setting to best assess device specificity. The study will be conducted in busy, ethnically and economically diverse cites affiliated with the Retina Foundation of the Southwest (RFSW) in greater Dallas, TX area. Each child will be screened with Rebiscan's RBI device and it's PVS device in sequence, with results compared to the PVS as well as a comprehensive ophthalmic examination performed by a certified pediatric ophthalmologist in a statistically appropriate subset of screened subjects. Testing times will be assessed to compare the efficiency of the PVS and the RBI screening experiences. The percentage of children successfully completing the screening process will also be measured. The RBI is expected to identify children with amblyopia and strabismus, without referring children who will not benefit from early treatment ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03919708
Study type Observational
Source Rebiscan, Inc.
Contact
Status Withdrawn
Phase
Start date February 4, 2020
Completion date May 31, 2023
View Details
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