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Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye

NCT03929588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2022-03-24

Study results available
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Summary

Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.

Conditions

  • Refractive Errors
  • Astigmatism

Interventions

DEVICE

Hand-held device supported by a mobile application

Hand-held device supported by a mobile application to obtain refractive error of the eye.

DEVICE

Phoropter

Manual refraction and ETDRS chart

DEVICE

Autorefractor

Automated refraction

Sponsors & Collaborators

  • EyeQue Corp.

    lead INDUSTRY

Principal Investigators

  • James Peace, MD · United Medical Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2020-03-31
Completion
2020-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03929588 on ClinicalTrials.gov