Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging

Amblyopia Clinical Trial

— RBI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03919708
• Other study ID #: rebiscan_RBI_RFSW
• Status: Withdrawn
• Start date: February 4, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: November 2023
• Source: Rebiscan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

Inclusion Criteria:

• Children who present to the participating clinics

• Provide assent

• Guardian provides informed consent

Exclusion Criteria:

• Developmental delay or cognitive deficit

Related Conditions & MeSH terms

• Amblyopia
• Strabismus

Intervention

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.

Locations

Country	Name	City	State
United States	Retina Foundation of the Southwest	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Rebiscan, Inc.	Retina Foundation of the Southwest

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of amblyopia / strabismus	Readouts of RBI device will be compared to clinical examination results	1 single day