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

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ClinicalTrials.gov Identifier: NCT03668067
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Alaska Blind Child Discovery

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
Refractive Errors Amblyopia Strabismus Development Delay 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.**


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Study Type : Observational [Patient Registry]
Actual Enrollment : 471 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort 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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
male and female children and adults with strabismus developmental delay is NOT excluded
Criteria

Inclusion Criteria:

  • patient undergoing eye examination

Exclusion Criteria:

  • none

Information from the National Library of Medicine

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


Locations
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United States, Alaska
Alaska Children's EYE & Strabismus
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Alaska Blind Child Discovery
Investigators
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Principal Investigator: Robert W Arnold, MD Alaska Blind Child Discovery

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Public de-identified ongoing

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alaska Blind Child Discovery
ClinicalTrials.gov Identifier: NCT03668067     History of Changes
Other Study ID Numbers: ABCD 2WIN bus
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified database on-line available
Supporting Materials: Study Protocol
Time Frame: late 2018
Access Criteria: public website
URL: http://www.abcd-vision.org/references/index.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Amblyopia
Strabismus
Refractive Errors
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases