MedPath

Performance of 2WIN Photoscreener With Corneal Reflex Compared to School Bus Retinoscopy by AAPOS Guidelines

Completed
Conditions
Development Delay
Amblyopia
Refractive Errors
Strabismus
Registration Number
NCT03668067
Lead Sponsor
Alaska Blind Child Discovery
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.\*\*

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
471
Inclusion Criteria
  • patient undergoing eye examination
Exclusion Criteria
  • none

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Amblyopia Risk Factor (refractive error and/or strabismus)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 Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Alaska Children's EYE & Strabismus

🇺🇸

Anchorage, Alaska, United States

Alaska Children's EYE & Strabismus
🇺🇸Anchorage, Alaska, United States
© Copyright 2025. All Rights Reserved by MedPath