An observational study in Refractive Errors, Amblyopia and Strabismus, sponsored by Alaska Blind Child Discovery. Completed at 1 site in United States. Open to participants aged 1 Week to 90 Years. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Alaska Blind Child Discovery · Observational
Pediatric eye patients receive infrared photoscreener screening and skiascopy as a part of routine examination to compare ability to detect amblyopia risk factors.
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.**
male and female children and adults with strabismus developmental delay is NOT excluded
Exclusion Criteria:
Accommodation, refraction and ocular alignment are estimated by infrared photoscreener using the photoscreener device. Photoscreener screening makes use of light crescent quantification from off-axis flash-to-lens in a camera.
Device: 2WIN photoscreener
Refractive error estimated by child-friendly skiascopy rack holding lenses from +1.00 D to +10.00 D and -5.00 D. Skiascopy is a common, old-fashioned form of retinoscopy.
conventional infrared off-axis photoscreener
Amblyopia Risk Factor (refractive error and/or strabismus)
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.
Time frame: 2 hours or less: Screening and Gold Standard Exam performed the same day, usually within the same hour.
Plan to share: Yes — de-identified database on-line available
Supporting information: Study protocol
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Alaska Blind Child Discovery