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OpenTrials
Completed

NCT Number: NCT01706991

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. All tests and observations will be done at a single visit over the course of approximately 30 minutes.

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Key information

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Doheny Eye Institute

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children aged 6 months to 6 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 eye scan

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

  • University of Southern California

Registry information

Official study title

MEPEDS New Device Pediatric Vision Scanner

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 15, 2012
Registry last updated
Oct 15, 2012

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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