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.\*\*

Study Timeline

• Study Start: 2018-04-02
• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

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

Name	Time	Method
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.

Trial Locations

Locations (1)

Alaska Children's EYE & Strabismus; 🇺🇸 Anchorage, Alaska, United States