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.**
420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.
This study's enrollment of 471 is above the median of 150 across 108 observational studies indexed under Refractive Errors.
Browse Refractive Errors studies →Alaska Blind Child Discovery is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
male and female children and adults with strabismus developmental delay is NOT excluded
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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
Time frame: late 2018
Access criteria: public website
Data sharing details ↗ · www.abcd-vision.org
Ran from Apr 2018 to primary completion in Oct 2018, 6 months.
Of 35 non-industry observational studies under Refractive Errors, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's 6 months is below that.
Counting every sponsor, half of 42 studies reached it within 19 months; a quarter within 8 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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