NCT03919708

Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Rebiscan, Inc. · Industry
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Accepted

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).

Detailed 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

Conditions

• Amblyopia
• Strabismus

Interventions

Type	Name	Description
DEVICE	Retinal Birefringence Imager	Device is a hand-help object approximately the size of a brick, and is held, by the user, 30cm away from the patient/subject. The subject peers in to an aperture that includes a fixation target that is in the shape of a smiley face. During this time, a ring of LED lights illuminates the eye and captures an image of the retina in approximately 3 seconds. The results instantaneously identify the presence of amblyopia / strabismus.

Timeline

• Start date: 2020-02-04
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2019-04-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study