Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner
NCT ID: NCT01726842
Last Updated: 2015-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2010-10-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Normal Controls
Structurally normal eye with equal visual acuity and normal stereopsis.
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.
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.
Pediatric Vision Scanner
Subject is scanned with a 2.5 second pediatric vision scanner device test.
Interventions
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Pediatric Vision Scanner
Subject is scanned with a 2.5 second pediatric vision scanner device test.
Eligibility Criteria
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Inclusion Criteria
* 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
2 Years
6 Years
ALL
Yes
Sponsors
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Retina Foundation of the Southwest
OTHER
Rebiscan, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eileen Birch, PhD
Role: PRINCIPAL_INVESTIGATOR
Retina Foundation of the Southwest
Locations
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Retina Foundation of the Southwest
Dallas, Texas, United States
Countries
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References
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Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503.
Other Identifiers
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rebiscan-001
Identifier Type: -
Identifier Source: org_study_id
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