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Refractive Accuracy of "2WIN" and Portable Autorefractors

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ClinicalTrials.gov Identifier: NCT04249505
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Alaska Blind Child Discovery

Brief Summary:
Youth and some adults have photoscreening refractions and hand-held auto refraction before cycloplegia refraction during new and follow up eye examinations. Vector math is applied to each refraction to determine how closely the hand-held "dry" devices match actual refraction.

Condition or disease Intervention/treatment
Refractive Error - Myopia Axial Astigmatism Accomodation Visual Impairment Hyperopia of Both Eyes Device: "2WIN" Photoscreener Device: "Plusoptix A12" Device: "Retinomax"

Detailed Description:

A closeness-of-fit algorithm utilizing vector transformations of astigmatism is designed and applied to 50-years of clinical international refractive experience.

As a part of new and follow up comprehensive eye examinations, patients and parents consented to confirm the cycloplegic refraction to other portable refractive tools.

The ability of photoscreeners "2WIN" ("Adaptica," Padova italy), "PlusoptiX A12" (Nuremberg, Germany) and "Retinomax" (Righton, Tokyo, Japan) to match actual refraction is assessed utilizing the new algorithm.

This algorithm could then be applied to batches of donated spectacles distend by charitable organizations worldwide if portable auto refracting devices are employed.

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Study Type : Observational
Actual Enrollment : 708 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Refractive Accuracy of Photoscreeners "2WIN" and "PlusoptiX" and the "Retinomax" Auto Refractor
Actual Study Start Date : January 9, 2020
Actual Primary Completion Date : April 1, 2021
Actual Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: "2WIN" Photoscreener
    non-cycloplegia refraction by Adaptica "2WIN"
  • Device: "Plusoptix A12"
    non-cycloplegic refraction by "Plusoptix A12" photoscreener
  • Device: "Retinomax"
    non-cycloplegic refraction by "Retinomax K+" auto refractor


Primary Outcome Measures :
  1. Refractive Accuracy [ Time Frame: 1 day ]
    spherical equivalent

  2. Refractive Accuracy [ Time Frame: 1 day ]
    Vector transform J0 and J45 astigmatism

  3. Refractive Accuracy [ Time Frame: 1 day ]
    Spectacle comparison score (Percent similarity combined sphere-cylinder)


Secondary Outcome Measures :
  1. Impact of age [ Time Frame: 1 day ]
    Spectacle similarity score striated by age relative to patient's ability to accommodate



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children and adults attending pediatric ophthalmology and adult strabismus clinic
Criteria

Inclusion Criteria:

  • Patient undergoing new or follow examination at pediatric eye and adult strabismus clinic Willing to undergo screening refractive device developmental delays included

Exclusion Criteria:

  • Intraocular lens in place

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): NCT04249505


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: Bob Arnold, MD Coordinator Alaska Blind Child Discovery
Publications:
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Responsible Party: Alaska Blind Child Discovery
ClinicalTrials.gov Identifier: NCT04249505    
Other Study ID Numbers: ABCD RefAcc
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified database shared on www.ABCD-Vision.org Website.
Supporting Materials: Analytic Code
Time Frame: after study completed
Access Criteria: open
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
Keywords provided by Alaska Blind Child Discovery:
photoscreening
photo refraction
auto refraction
spectacle dispensing
Additional relevant MeSH terms:
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Vision Disorders
Vision, Low
Astigmatism
Refractive Errors
Hyperopia
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases