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Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01706991
First Posted: October 15, 2012
Last Update Posted: October 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Rebiscan, Inc.
  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

Resource links provided by NLM:


Further study details as provided by Rebiscan, Inc.:

Primary Outcome Measures:
  • Binocularity score [ Time Frame: Day 1 ]

Secondary Outcome Measures:
  • Presence of amblyopia risk factors [ Time Frame: Day 1 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 5, 2012
First Posted: October 15, 2012
Last Update Posted: October 15, 2012
Last Verified: October 2012

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