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

Completed

• Conditions: Development Delay; Amblyopia; Refractive Errors; Strabismus
• Interventions: Device: 2WIN photoscreener

• 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

Arm && Interventions

Group	Intervention	Description
Photoscreener (2WIN)	2WIN photoscreener	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.

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