Working… Menu

Refractive Accuracy of "2WIN" and Portable Autorefractors

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. Identifier: NCT04249505
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : July 23, 2021
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.

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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 identifier (NCT number): NCT04249505

Layout table for location information
United States, Alaska
Alaska Children's EYE & Strabismus
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Alaska Blind Child Discovery
Layout table for investigator information
Principal Investigator: Bob Arnold, MD Coordinator Alaska Blind Child Discovery
Layout table for additonal information
Responsible Party: Alaska Blind Child Discovery 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 Website.
Supporting Materials: Analytic Code
Time Frame: after study completed
Access Criteria: open

Layout table for additional information
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:
photo refraction
auto refraction
spectacle dispensing
Additional relevant MeSH terms:
Layout table for MeSH terms
Vision Disorders
Vision, Low
Refractive Errors
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases