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Improving Quality Vision Outcomes in Managed Care Setting While Reducing Cost by Use of Accurate, Automated Screening

NCT02536963 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 318

Last updated 2020-07-01

Study results available
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Summary

Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that combine as the leading causes of preventable vision loss in children. They are irreversible if not detected and corrected by the age of seven, however half of all cases are missed because the conditions do not always manifest themselves and pediatricians are unable to reliably detect the conditions. The current health care system badly needs an accurate and effective approach toward detecting amblyopia and strabismus in preschool children.

The study will be conducted in busy, ethnically and racially diverse primary care sites operated by the Kaiser Permanente system and compare the outcomes of testing with a Pediatric Vision Scanner with outcomes the current standard of care.

Conditions

  • Amblyopia
  • Strabismus

Interventions

DEVICE

Pediatric Vision Scanning device

The Pediatric Vision Scanner (PVS) performs a 3-second, non-invasive scan of both eyes simultaneously while a child looks at a single target. The scan will measure the frequency of the light waves that reflect off of the participants' eyes to determine the fixation state of the eye.

OTHER

Reference examination

Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist.

Sponsors & Collaborators

  • Kaiser Foundation Research Institute

    collaborator OTHER

  • Rebiscan, Inc.

    lead INDUSTRY

Principal Investigators

  • Ashish Mehta, MD · Kaiser Permanente

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02536963 on ClinicalTrials.gov