Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

MEPEDS New Device Pediatric Vision Scanner

The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus. All tests and observations will be done at a single visit over the course of approximately 30 minutes.

Study Overview

• Status: Completed
• Conditions: Strabismus; Amblyopia
• Intervention / Treatment: Device: Pediatric Vision Scanner eye scan

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Doheny Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children presenting for ophthalmic exam at eye clinic.

Description

Inclusion Criteria:

• Children aged 6 months to 6 years
• Signed Informed consent by parent or guardian
• Meet all inclusion criteria.

Exclusion Criteria:

• Children with a history of developmental delay or cognitive deficit
• Children unable to complete the GSE (including visual acuity testing)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Controls; Structurally normal eye with equal visual acuity and normal stereopsis.	Device: Pediatric Vision Scanner eye scan; Subject is scanned with a 2.5 second pediatric vision scanner device test.
Referral required; Diagnosed with amblyopia or constant strabismus, categorized based on the GSE. Amblyopia: VA <20/40 and 2 logMAR lines difference in normal eye; Mild amblyopia (>20/40); Moderate amblyopia (20/40 and <20/100); Severe amblyopia (≥20/100 or worse); Bilateral amblyopia: >4 years age VA<20/40 OU including high hyperopia or high astigmatism. Strabismus: Constant: >2 PD at near and or distance.; Intermittent: strabismus that could be controlled intermittently either through fusional mechanisms or a compensatory head position. Amblyogenic factor categorization: 'Anisometropia'- (1.5 Diopters (D) or more difference in refractive error between the two eyes.; 'hypermetropia' (≥3.5 D),; 'myopia' (≥-4.0 D),; 'astigmatism' (≥1.5 D).; 'structural abnormalities' of the eye will not be excluded, but will be considered to have vision loss if visual acuity is 20/40 or worse.	Device: Pediatric Vision Scanner eye scan; Subject is scanned with a 2.5 second pediatric vision scanner device test.
Borderline; (no long-term harm to patient if referral is delayed, however the patient does have conditions that might benefit from monitoring): Equal visual acuity and no structural abnormality with any of the following: Amblyogenic factor, intermittent strabismus, structural abnormalities, refractive error, reduced stereopsis.	Device: Pediatric Vision Scanner eye scan; Subject is scanned with a 2.5 second pediatric vision scanner device test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocularity score	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Presence of amblyopia risk factors	Day 1

Collaborators and Investigators

• Sponsor: Rebiscan, Inc.
• Collaborators: University of Southern California
• Investigators: Principal Investigator: Rohit Varma, MD, PhD, University of Southern California

Publications and helpful links

General Publications

• Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: October 5, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (Estimate): October 15, 2012

Study Record Updates

• Last Update Posted (Estimate): October 15, 2012
• Last Update Submitted That Met QC Criteria: October 12, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Cranial Nerve Diseases; Sensation Disorders; Ocular Motility Disorders; Vision Disorders; Strabismus; Amblyopia
• Other Study ID Numbers: rebiscan-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No