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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|