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Amblyopia and Strabismus Detection Using Retinal Birefringence Imaging

NCT03919708 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Retina Foundation of the Southwest

    collaborator OTHER

  • Rebiscan, Inc.

    lead INDUSTRY

Principal Investigators

  • Eileen Birch, PhD · Retina Foundation of the Southwest

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2023-05-31
Completion
2023-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03919708 on ClinicalTrials.gov