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

Pediatric eye patients receive infrared photoscreener screening and skiascopy as a part of routine examination to compare ability to detect amblyopia risk factors.

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Key information

Conditions

Refractive Errors Amblyopia Brain Diseases Central Nervous System Diseases Communication Disorders Cranial Nerve Diseases Development Delay Eye Diseases Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Ocular Motility Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Strabismus Vision Disorders

Age range

1 week–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alaska Children's EYE & Strabismus

Anchorage, Alaska, 99508, United States

About this study

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.**

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patient undergoing eye examination

Exclusion criteria

none

Treatment and study plan

2WIN photoscreener

Device

conventional infrared off-axis photoscreener

Primary outcomes

Amblyopia Risk Factor (refractive error and/or strabismus)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alaska Blind Child Discovery

Other

Registry information

Official study title

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

Acronym: 2WINbus

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Sep 12, 2018
Registry last updated: Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed