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

Sponsor
Alaska Blind Child Discovery (Other)
Overall Status
Completed
CT.gov ID
NCT03668067
Collaborator
(none)
471
Enrollment
1
Location
7
Actual Duration (Months)
67.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 2WIN photoscreener

Detailed Description

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
471 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Refractive and Strabismic Amblyopia Risk Factors Detected by Infrared Photoscreener and School Bus Skiascopy
Actual Study Start Date :
Apr 2, 2018
Actual Primary Completion Date :
Oct 31, 2018
Actual Study Completion Date :
Oct 31, 2018

Arms and Interventions

Arm Intervention/Treatment
2WIN

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Week to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patient undergoing eye examination
Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alaska Children's EYE & Strabismus Anchorage Alaska United States 99508

Sponsors and Collaborators

  • Alaska Blind Child Discovery

Investigators

  • Principal Investigator: Robert W Arnold, MD, Alaska Blind Child Discovery

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alaska Blind Child Discovery
ClinicalTrials.gov Identifier:
NCT03668067
Other Study ID Numbers:
  • ABCD 2WIN bus
First Posted:
Sep 12, 2018
Last Update Posted:
Oct 19, 2020
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Amblyopia
Strabismus
Refractive Errors

Study Results

No Results Posted as of Oct 19, 2020