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Completed

NCT Number: NCT01832883

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

3 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt Eye Institute

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children aged 3-8 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)

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

    '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.

Sponsors and collaborators

Lead sponsor

Rebiscan, Inc.

Industry

Collaborators

  • Vanderbilt University

Registry information

Official study title

Pediatric Vision Scanner 4 (PVS4)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 16, 2013
Registry last updated
Apr 13, 2018

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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