Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging

NCT03919708 | Withdrawn FDA Device

• 1 other identifier: rebiscan_RBI_RFSW
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Amblyopia; Strabismus

Outcome Measures

Primary Outcomes (1)

• Presence of amblyopia / strabismus

  Readouts of RBI device will be compared to clinical examination results

  1 single day

Study Arms (2)

Enriched Population

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.

Device: Retinal Birefringence Imager

Unenriched Population

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.

Device: Retinal Birefringence Imager

Interventions

Retinal Birefringence Imager DEVICE

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.

Also known as: RBI

Enriched Population; Unenriched Population

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children between the ages of 2-8, with no gender, race, or ethnicity restricted from enrollment.

You may qualify if:

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

You may not qualify if:

• \- Developmental delay or cognitive deficit

Sponsors & Collaborators

• Rebiscan, Inc.: lead
• Retina Foundation of the Southwest: collaborator

Study Sites (1)

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Amblyopia; Strabismus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases

Study Officials

• Eileen Birch, PhD

  Retina Foundation of the Southwest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 18, 2019
• Study Start: February 4, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)