NCT03668067

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

Refractive and Strabismic Amblyopia Risk Factors Detected by Infrared Photoscreener and School Bus Skiascopy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 471 (actual)
• Sponsor: Alaska Blind Child Discovery · Academic / Other
• Sex: All
• Age: 1 Week – 90 Years
• Healthy volunteers: Not accepted

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.\*\*

Conditions

• Refractive Errors
• Amblyopia
• Strabismus
• Development Delay

Interventions

Type	Name	Description
DEVICE	2WIN photoscreener	conventional infrared off-axis photoscreener

Timeline

• Start date: 2018-04-02
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2018-09-12
• Last updated: 2024-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study