Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03668067
Acronym
2WINbus
Enrollment
471
Registered
2018-09-12
Start date
2018-04-02
Completion date
2018-10-31
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia, Development Delay, Refractive Errors, Strabismus

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.\*\*

Interventions

conventional infrared off-axis photoscreener

Sponsors

Alaska Blind Child Discovery
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 90 Years
Healthy volunteers
No

Inclusion criteria

* patient undergoing eye examination

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026