Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

April 11, 2018 updated by: Rebiscan, Inc.

Pediatric Vision Scanner 4 (PVS4)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

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

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Eye Institute

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

3 years to 8 years (CHILD)

Accepts Healthy Volunteers

Yes

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 3-8 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal Controls
Structurally normal eye with equal visual acuity and normal stereopsis.
Device: Pediatric Vision Scanner
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
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
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
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of amblyopia risk factors
Time Frame: Day 1

'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.
Day 1

Collaborators and Investigators

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

Sponsor

Rebiscan, Inc.

Collaborators

Vanderbilt University

Investigators

  • Principal Investigator: Sean Donahue, MD, PhD, Vanderbilt Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2010

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

October 5, 2012

First Submitted That Met QC Criteria

April 11, 2013

First Posted (ESTIMATE)

April 16, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2018

Last Update Submitted That Met QC Criteria

April 11, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rebiscan-002

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.

Clinical Trials on Strabismus

Clinical Trials on Pediatric Vision Scanner

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe