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OpenTrials
Completed

NCT Number: NCT04249505

Refractive Accuracy of "2WIN" and Portable Autorefractors

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.

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Key information

Conditions

Refractive Error - Myopia Axial Accomodation Astigmatism Eye Diseases Hyperopia of Both Eyes Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Refractive Errors Sensation Disorders Signs and Symptoms Vision Disorders Visual Impairment

Age range

6 month–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alaska Children's EYE & Strabismus

Anchorage, Alaska, 99508, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"2WIN" Photoscreener

Device

non-cycloplegia refraction by Adaptica "2WIN"

"Plusoptix A12"

Device

non-cycloplegic refraction by "Plusoptix A12" photoscreener

"Retinomax"

Device

non-cycloplegic refraction by "Retinomax K+" auto refractor

Primary outcomes

  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 outcomes

  1. Impact of age

    Time frame: 1 day

    Spectacle similarity score striated by age relative to patient's ability to accommodate

Sponsors and collaborators

Lead sponsor

Alaska Blind Child Discovery

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2020
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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