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EyeQue VisionCheck 510(k) Clinical Trial

NCT06044688•EyeQue Corp.

Summary

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

Detailed Description

The primary purpose of this study is to attain scientific objective evidence to support the VisionCheck Indications for Use by demonstrating that refraction measurements from the device agree with refraction measurements from a phoropter within clinically meaningful limits. The Indications for Use are: "The EyeQue VisionCheck automated subjective refraction system provides an estimate of sphere, cylinder, and axis measurements of the eye" Furthermore, the purpose of this study is to attain scientific objective evidence regarding the precision of the VisionCheck device.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Each participant must meet the following criteria to be enrolled in this study:
•1. Participant or legally authorized representative (LAR) is willing and able to give informed consent
•2. Participant is willing and able to follow all study procedures and requirements
•3. Participant is able to use a smartphone
•4. Participant is interested in getting refraction correction measurement
•5. Participant is able to speak, read and write English fluently

Exclusion Criteria

•Participants who meet any of the following criteria will be excluded from the study:
•1. Spherical correction \>+8D or \<-10D (outside the range of the VisionCheck measurement)
•2. Astigmatism correction of less than -5D (optometric notation, outside the range of the VisionCheck measurement)
•3. Inability to see the red and green lines (may be overlapped to form a, partially, yellow line) through the VisionCheck device
•4. Participant does not have the physical dexterity to properly operate the EyeQue VisionCheck device or the EyeQue app on the smartphone in the Investigator's opinion
•5. Has initiated any new medication in the two weeks prior to enrolling in this study that, in the best medical judgment of the Investigator, would impact their participation in the study or ability to use the EyeQue VisionCheck device
•6. Eye surgery within 12 months prior to enrolling in this study (including Lasik or lens replacement)
•7. Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect vision within the greater of three days or five half-lives prior to enrolling in this study
•8. Using an investigational drug or approved therapy for investigational use within the greater of three days or five half-lives prior to enrolling in this study
•9. Color deficiency (Ishihara pseudoisochromatic plates: Concise 14-plate edition: six or more errors on plates 1-11; the 24-plate edition: seven or more errors on plates 1-15; the 38-plate edition: nine or more errors on plates 1-21)
+17 more criteria

Key Dates

Start Date

October 1, 2023

Primary Completion Date

November 1, 2023

Completion Date

November 1, 2023

Last Updated

September 21, 2023

Enrollment

156

ESTIMATED participants

Conditions

Refractive ErrorsAstigmatism

Interventions

EyeQue VisionCheck

DEVICE

Phoropter

DEVICE

Contacts

Noam Sapiens, PhD

CONTACT

510-455-8168 noam.sapiens@eyeque.com

Cognitive Level Enhancement Through Vision Exams and Refraction

NCT05458323

Refractive Errors

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RECRUITINGNA

Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery

NCT07078799

MyopiaAstigmatism

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RECRUITING

Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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EyeQue VisionCheck 510(k) Clinical Trial

Inclusion Criteria

Exclusion Criteria

Cognitive Level Enhancement Through Vision Exams and Refraction

Wavefront-guided LASIK Surgery Compared to Ray Tracing-Guided LASIK Surgery

Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser

Clinical Evaluation of WaveLight Plus LASIK

A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism

Patient Reported Outcomes With WaveLight Plus LASIK