Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging (RBI)

November 16, 2023 updated by: Rebiscan, Inc.

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75231
        • Retina Foundation of the Southwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Developmental delay or cognitive deficit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • RBI
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
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.
Other Names:
  • RBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of amblyopia / strabismus
Time Frame: 1 single day
Readouts of RBI device will be compared to clinical examination results
1 single day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rebiscan, Inc.

Collaborators

Retina Foundation of the Southwest

Investigators

  • Principal Investigator: Eileen Birch, PhD, Retina Foundation of the Southwest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2020

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 18, 2019

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rebiscan_RBI_RFSW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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