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

NCT ID: NCT03929588

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-07
• Study Completion Date: 2020-03-31

Brief 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.

Detailed Description

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 in male or female subjects 30 to 65 years of age.

Conditions

Refractive Errors; Astigmatism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Refraction with a Hand-held Device Supported by Mobile App.

BCVA with handheld device with app.

Group Type: EXPERIMENTAL

Phoropter

Intervention Type: DEVICE

Manual refraction and ETDRS chart

Autorefractor

Intervention Type: DEVICE

Automated refraction

Manual Refraction

BCVA with phoropter

Group Type: ACTIVE_COMPARATOR

Hand-held device supported by a mobile application

Intervention Type: DEVICE

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

Automated Refraction

BCVA with autorefractoer

Group Type: ACTIVE_COMPARATOR

Hand-held device supported by a mobile application

Intervention Type: DEVICE

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

Interventions

Hand-held device supported by a mobile application

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

Intervention Type: DEVICE

Phoropter

Manual refraction and ETDRS chart

Intervention Type: DEVICE

Autorefractor

Automated refraction

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or Female
• Age 30 through 65 years at the time of consent
• Binocular vision
• Subject desires refraction for correction of visual acuity and vision can be corrected in each eye to 20/20 (LogMAR 0.0)
• Willing and able to give informed consent and follow all study procedures and requirements
• Ability to speak and understand the English language

Exclusion Criteria

• Spherical correction > +8 or < -10
• Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study
• Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study
• Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the device
• Eye disease, including but not limited to:

• Glaucoma (≥ 22 mmHg intraocular pressure)
• Cataracts (≥ 1+ nuclear sclerotic cataract, ≥ 1+ cortical, posterior subcapsular cataract [any grade using the Lens Opacities Classification System III])
• Macular degeneration (retinal pigmented epithelium mottling and/or any drusen within 500 μm of macula)
• Eye infection (corneal ulcer, corneal infiltrates, superficial punctate keratitis)
• Keratoconus
• Diabetic neuropathy/retinopathy (≥ mild nonproliferative diabetic retinopathy)
• Cytomegalovirus retinitis
• Color blindness (any color deficiency)
• Diabetic macular edema (evidence of fluid)
• Amblyopia
• Chronic or acute uveitis (cells and/or flare in anterior chamber)
• Strabismus (exotropia, esotropia, and hypertropia)
• Abnormal astigmatism (mild to severe, > 5 diopters)
• Macular hole
• Eye surgery within the last 12 months (including Lasik or lens replacement)
• Subject does not have the physical dexterity to properly operate the device or the on the smartphone in the investigator's opinion.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EyeQue Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Peace, MD

Role: PRINCIPAL_INVESTIGATOR

United Medical Research Institute

Locations

United Medical Research Institute

Inglewood, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EYEQUE - 001

Identifier Type: -

Identifier Source: org_study_id