EyeQue VisionCheck 510(k) Clinical Trial

NCT06044688 | Unknown FDA Device

• 1 other identifier: EYEQUE-011
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Refractive Errors; Astigmatism

Keywords

Myopia; Hyperopia

Outcome Measures

Primary Outcomes (2)

• Assess agreement between the VisionCheck refraction measurement and a phoropter (standard of care) refraction measurement.

  Bland-Altman limits of agreement (LoA) for within-eye differences between refraction measurements of sphere, cylinder, and axis obtained from VisionCheck and the subjective phoropter

  3 months

• Assess total variability and variance components for between- replicates (repeatability) and between-device/operator while adjusting for between-participant and between-site variability.

  Percent coefficient of variation (%CV) and standard deviation (SD) of refraction measurement outputs in the form of sphere, cylinder, and axis obtained from VisionCheck

  3 months

Secondary Outcomes (2)

• Assess improvement in visual acuity brought forth by the VisionCheck refraction measurement.

  3 months

• Assess the safety of the VisionCheck device.

  3 months

Study Arms (2)

Phoropter

EXPERIMENTAL

Refraction performed by an eye care professional using a phoropter.

Device: Phoropter

VisionCheck

ACTIVE COMPARATOR

Self-administered refraction performed using the EyeQue VisionCheck device.

Device: EyeQue VisionCheck

Interventions

EyeQue VisionCheck DEVICE

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

VisionCheck

Phoropter DEVICE

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

Phoropter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from the study:
• Spherical correction \>+8D or \<-10D (outside the range of the VisionCheck measurement)
• Astigmatism correction of less than -5D (optometric notation, outside the range of the VisionCheck measurement)
• Inability to see the red and green lines (may be overlapped to form a, partially, yellow line) through the VisionCheck device
• 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
• 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
• Eye surgery within 12 months prior to enrolling in this study (including Lasik or lens replacement)
• 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
• 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
• 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)
• Neurological and developmental conditions that may affect the outcome of the trial including, but not limited to, Multiple Sclerosis (MS), Stroke, Traumatic Brain Injury (TBI), Parkinson's Disease, Alzheimer's Disease, Dementia, Migraines, Optic Neuropathies, Brain Tumors, Hereditary Conditions (such as Leber's hereditary optic neuropathy (LHON) or retinitis pigmentosa), Epilepsy, Diplopia. Investigator discretion shall be applied to any additional conditions not listed.
• Eye pathologies, including but not limited to:
• Glaucoma
• Any macular disease including macular degeneration, macular hole, macular dystrophy, epiretinal membrane, retinal vein occlusion, macular telangiectasia, central serous chorioretinopathy and cystoid macular edema
• Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis, ocular histoplasmosis syndrome)

Sponsors & Collaborators

• EyeQue Corp.: lead
• The Emmes Company, LLC: collaborator

MeSH Terms

Conditions

Refractive Errors; Astigmatism; Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Noam Sapiens, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical site staff are masked to VisionCheck results. Participants are masked to VisionCheck and phoropter refraction measurements. The eyecare professionals performing Visit 2 refraction readings are masked to Visit 1 screening refraction readings.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 21, 2023
• Study Start: October 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share