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EyeQue VisionCheck 510(k) Clinical Trial

NCT06044688 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2023-09-21

No results posted yet for this study

Summary

Demonstrate that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits.

Conditions

  • Refractive Errors
  • Astigmatism

Interventions

DEVICE

EyeQue VisionCheck

Automated subjective refraction system provides estimates of sphere, cylinder, and axis measurements of the eye.

DEVICE

Phoropter

Standard of care, ophthalmic testing device, used by eye care professionals to measure the refractive error of the eye and determine prescription.

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • EyeQue Corp.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Device
Yes

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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 NCT06044688 on ClinicalTrials.gov