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Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

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ClinicalTrials.gov Identifier: NCT01726842
Recruitment Status : Completed
First Posted : November 15, 2012
Last Update Posted : October 29, 2015
Sponsor:
Collaborator:
Retina Foundation of the Southwest
Information provided by (Responsible Party):
Rebiscan, Inc.

Brief Summary:
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 or disease Intervention/treatment
Amblyopia Strabismus Device: Pediatric Vision Scanner

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pediatric Vision Scanner for the Eradication of Amblyopia
Study Start Date : October 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

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.




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

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


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Ages Eligible for Study:   2 Years 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:

  • 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

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): NCT01726842


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

Publications:
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Responsible Party: Rebiscan, Inc.
ClinicalTrials.gov Identifier: NCT01726842     History of Changes
Other Study ID Numbers: rebiscan-001
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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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