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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

Tracking Information
First Submitted Date January 29, 2020
First Posted Date January 31, 2020
Last Update Posted Date July 23, 2021
Actual Study Start Date January 9, 2020
Actual Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2020)
  • Refractive Accuracy [ Time Frame: 1 day ]
    spherical equivalent
  • Refractive Accuracy [ Time Frame: 1 day ]
    Vector transform J0 and J45 astigmatism
  • Refractive Accuracy [ Time Frame: 1 day ]
    Spectacle comparison score (Percent similarity combined sphere-cylinder)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 29, 2020)
Impact of age [ Time Frame: 1 day ]
Spectacle similarity score striated by age relative to patient's ability to accommodate
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Refractive Accuracy of "2WIN" and Portable Autorefractors
Official Title The Refractive Accuracy of Photoscreeners "2WIN" and "PlusoptiX" and the "Retinomax" Auto Refractor
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population children and adults attending pediatric ophthalmology and adult strabismus clinic
Condition
  • Refractive Error - Myopia Axial
  • Astigmatism
  • Accomodation
  • Visual Impairment
  • Hyperopia of Both Eyes
Intervention
  • 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
Study Groups/Cohorts Not Provided
Publications * Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 21, 2021)
708
Original Estimated Enrollment
 (submitted: January 29, 2020)
500
Actual Study Completion Date April 1, 2021
Actual Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 95 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04249505
Other Study ID Numbers ABCD RefAcc
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
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
Responsible Party Alaska Blind Child Discovery
Study Sponsor Alaska Blind Child Discovery
Collaborators Not Provided
Investigators
Principal Investigator: Bob Arnold, MD Coordinator Alaska Blind Child Discovery
PRS Account Alaska Blind Child Discovery
Verification Date July 2020