NCT01706991CompletedNot Applicable
MEPEDS New Device Pediatric Vision Scanner
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rebiscan, Inc.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Binocularity score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Months to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Binocularity score
Time Frame: Day 1
Secondary Outcomes
- Presence of amblyopia risk factors(Day 1)
Investigators
Study Sites (1)
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