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NCT04249505 Clinical Trial

Refractive Accuracy of "2WIN" and Portable Autorefractors

Astigmatism Clinical Trial

Official title:
The Refractive Accuracy of Photoscreeners "2WIN" and "PlusoptiX" and the "Retinomax" Auto Refractor

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04249505
Other study ID # ABCD RefAcc
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 9, 2020
Est. completion date April 1, 2021

Study information
Verified date July 2020
Source Alaska Blind Child Discovery
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 708
Est. completion date April 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 95 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Alaska Children's EYE & Strabismus Anchorage Alaska

Sponsors (1)
Lead Sponsor Collaborator
Alaska Blind Child Discovery

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Refractive Accuracy spherical equivalent 1 day
Primary Refractive Accuracy Vector transform J0 and J45 astigmatism 1 day
Primary Refractive Accuracy Spectacle comparison score (Percent similarity combined sphere-cylinder) 1 day
Secondary Impact of age Spectacle similarity score striated by age relative to patient's ability to accommodate 1 day
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