Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging

Withdrawn

• Conditions: Strabismus; Amblyopia
• Interventions: Device: Retinal Birefringence Imager

• Registration Number: NCT03919708
• Lead Sponsor: Rebiscan, Inc.

Brief 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

Study Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-18
• Study Start: 2020-02-04
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Children who present to the participating clinics
• Provide assent
• Guardian provides informed consent

Exclusion Criteria

• Developmental delay or cognitive deficit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enriched Population	Retinal Birefringence Imager	Children between the ages of 2-8 who present to an eye clinic. Eligible and recruited children will be scanned with a PVS device and an RBI device, and then be provided with a full, gold standard eye exam by a pediatric ophthalmologist. All scans and exam should be performed within a single visit. Scans should take no longer than 20 seconds each, and ophthalmic exam should take approximately 30 minutes.
Unenriched Population	Retinal Birefringence Imager	Children between the ages of 2-8 who present to a general pediatric clinic, with no history of eye disorders or amblyopia. Eligible and recruited children will be scanned with a PVS device and an RBI device, and then be provided with a full, gold standard eye exam by a pediatric ophthalmologist. All scans will be performed at a single visit, but the exam may require a follow up visit, depending on the availability of a pediatric ophthalmologist at the clinic at the time of study enrollment. Scans should take no longer than 20 seconds each, and ophthalmic exam should take approximately 30 minutes.

Primary Outcome Measures

Name	Time	Method
Presence of amblyopia / strabismus	1 single day	Readouts of RBI device will be compared to clinical examination results

Trial Locations

Locations (1)

Retina Foundation of the Southwest; 🇺🇸 Dallas, Texas, United States