Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging

N/AWithdrawnNCT03919708

Rebiscan, Inc.

Overview

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).

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 Type

OBSERVATIONAL

Conditions

Amblyopia Strabismus

Interventions

Retinal Birefringence ImagerDEVICE

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Children who present to the participating clinics * Provide assent * Guardian provides informed consent Exclusion Criteria: \- Developmental delay or cognitive deficit

Locations (1)

Retina Foundation of the Southwest

Dallas, Texas, United States

Outcomes

Primary Outcomes

Presence of amblyopia / strabismus

Readouts of RBI device will be compared to clinical examination results

Time frame: 1 single day

Data from ClinicalTrials.gov

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