Refractive Accuracy of "2WIN" and Portable Autorefractors

NCT ID: NCT04249505

Last Updated: 2021-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

708 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-09

Study Completion Date

2021-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

"2WIN" Photoscreener

non-cycloplegia refraction by Adaptica "2WIN"

Intervention Type DEVICE

"Plusoptix A12"

non-cycloplegic refraction by "Plusoptix A12" photoscreener

Intervention Type DEVICE

"Retinomax"

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Months

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alaska Blind Child Discovery

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bob Arnold, MD

Role: PRINCIPAL_INVESTIGATOR

Coordinator Alaska Blind Child Discovery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alaska Children's EYE & Strabismus

Anchorage, Alaska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31077668 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ABCD RefAcc

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Early Intervention for Premyopic Children
NCT06200194 ACTIVE_NOT_RECRUITING PHASE2
Spectacle Lens Visual Acuity Assessments Study
NCT05650190 ACTIVE_NOT_RECRUITING NA