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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Accomodation
• Astigmatism
• Hyperopia
• Hyperopia of Both Eyes
• Refractive Error - Myopia Axial
• Refractive Errors
• Vision Disorders
• Vision, Low
• Visual Impairment

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