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Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Retina Foundation of the Southwest
Information provided by (Responsible Party):
Rebiscan, Inc.
ClinicalTrials.gov Identifier:
NCT01726842
First received: October 5, 2012
Last updated: November 11, 2012
Last verified: November 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.


Condition Intervention
Amblyopia
Strabismus
 Device: Pediatric Vision Scanner

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pediatric Vision Scanner for the Eradication of Amblyopia

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 ]

Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: December 2012 (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
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.

  Eligibility

Ages Eligible for Study:   2 Years 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:

  • 2-6 years old
  • complete ophthalmic examination including cycloplegic refraction conducted on the same day or within 3 months
  • strabismic, anisometropic, or normal (normal eye examination and refractive error according to AAPOS guidelines)
  • parent provides informed consent

Exclusion:

  • other ocular disease (includes media opacities, anomalous optic nerve, ptosis, lid hemangioma, conjunctivitis, blepharitis, symptomatic NLD) or systemic disease (JIA, JRA, neurofibromatosis)
  • developmental delay
  • strabismus surgery in the past 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726842

Locations
United States, Texas
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Rebiscan, Inc.
Retina Foundation of the Southwest
Investigators
Principal Investigator: Eileen Birch, PhD Retina Foundation of the Southwest
  More Information

Publications:

Responsible Party: Rebiscan, Inc.
ClinicalTrials.gov Identifier: NCT01726842     History of Changes
Other Study ID Numbers: rebiscan-001
Study First Received: October 5, 2012
Last Updated: November 11, 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 May 19, 2013