Performance of 2WIN Photoscreener With Corneal Reflex Compared to School Bus Retinoscopy by AAPOS Guidelines (2WINbus)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03668067|
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment|
|Refractive Errors Amblyopia Strabismus Development Delay||Device: 2WIN photoscreener|
Patients: Pediatric eye and adult strabismus patients undergoing routine examinations in a private ophthalmology practice.
Interventions: Infrared photoscreener / remote autorefractor 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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||471 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Refractive and Strabismic Amblyopia Risk Factors Detected by Infrared Photoscreener and School Bus Skiascopy|
|Actual Study Start Date :||April 2, 2018|
|Actual Primary Completion Date :||October 31, 2018|
|Actual Study Completion Date :||October 31, 2018|
Accommodation, refraction and ocular alignment are estimated by infrared photoscreener using the 2WIN photoscreener device. Photoscreener screening makes use of light crescent quantification from off-axis flash-to-lens in a camera.
Device: 2WIN photoscreener
conventional infrared off-axis photoscreener
school bus skiascopy
Refractive error estimated by child-friendly skiascopy rack holding lenses from +1.00 D to +10.00 D and -5.00 D. Skiascopy is a common, old-fashioned form of retinoscopy.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668067
|United States, Alaska|
|Alaska Children's EYE & Strabismus|
|Anchorage, Alaska, United States, 99508|
|Principal Investigator:||Robert W Arnold, MD||Alaska Blind Child Discovery|