NCT04249505

Refractive Accuracy of "2WIN" and Portable Autorefractors

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 708 (actual)
• Sponsor: Alaska Blind Child Discovery · Academic / Other
• Sex: All
• Age: 6 Months – 95 Years
• Healthy volunteers: Accepted

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.

Conditions

• Refractive Error - Myopia Axial
• Astigmatism
• Accomodation
• Visual Impairment
• Hyperopia of Both Eyes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-09
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2020-01-31
• Last updated: 2021-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study