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OpenTrials
Completed

NCT Number: NCT01726842

Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner

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.

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Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Ocular Motility Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Strabismus Vision Disorders

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric Vision Scanner

Device

Subject is scanned with a 2.5 second pediatric vision scanner device test.

Primary outcomes

  1. Binocularity score

    Time frame: Day 1

Secondary outcomes

  1. Presence of amblyopia risk factors

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Rebiscan, Inc.

Industry

Collaborators

  • Retina Foundation of the Southwest

Registry information

Official study title

Pediatric Vision Scanner for the Eradication of Amblyopia

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 15, 2012
Registry last updated
Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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