Refractive and Strabismic Amblyopia Risk Factors Detected by Infrared Photoscreener and School Bus Skiascopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 471
- Locations
- 1
- Primary Endpoint
- Amblyopia Risk Factor (refractive error and/or strabismus)
Study Overview
Brief Summary
Pediatric eye patients receive infrared photoscreener screening and skiascopy as a part of routine examination to compare ability to detect amblyopia risk factors.
Detailed Description
Patients: Pediatric eye and adult strabismus patients undergoing routine examinations in a private ophthalmology practice.
Interventions: Infrared photoscreener / remote autorefractor such as 2 Winner (2WIN) ("Adaptica" - Padova, Italy) without and with infrared corneal reflex occluder. Child-friendly skiascopy before and after cycloplegic refraction.
Outcome: Amblyopia Risk Factors from comprehensive eye exam including refraction and strabismus.
Risk factors defined by American Association for Pediatric Ophthalmology and Strabismus (AAPOS) 2003 and 2013 guidelines.
**Please note that 2 Winner has nothing to do with actual device, but was required by the Clinical Trials Web entry.**
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Week to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patient undergoing eye examination
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Amblyopia Risk Factor (refractive error and/or strabismus)
Time Frame: 2 hours or less: Screening and Gold Standard Exam performed the same day, usually within the same hour.
Whether pre-defined, age-related risk factor is present. AAPOS has published standard levels of these refractive errors or binocular misalignment that render a child at risk of developing sight-threatening amblyopia.
Secondary Outcomes
No secondary outcomes reported