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Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

This study has been completed.
Sponsor:
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Rebiscan, Inc.
ClinicalTrials.gov Identifier:
NCT01706991
First received: October 5, 2012
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Amblyopia
Strabismus
 Device: Pediatric Vision Scanner eye scan

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: MEPEDS New Device Pediatric Vision Scanner

Further study details as provided by Rebiscan, Inc.:

Primary Outcome Measures:
  • Binocularity score [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Presence of amblyopia risk factors [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children presenting for ophthalmic exam at eye clinic.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706991

Locations
United States, California
Doheny Eye Institute
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Rebiscan, Inc.
University of Southern California
Investigators
Principal Investigator: Rohit Varma, MD, PhD University of Southern California
  More Information

Publications:

Responsible Party: Rebiscan, Inc.
ClinicalTrials.gov Identifier: NCT01706991     History of Changes
Other Study ID Numbers: rebiscan-003
Study First Received: October 5, 2012
Last Updated: October 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Amblyopia
Strabismus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
 Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases

ClinicalTrials.gov processed this record on June 13, 2013