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

NCT03929588 | Completed Results FDA Device

• 1 other identifier: EYEQUE - 001
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Errors; Astigmatism

Keywords

myopia; hyperopia

Outcome Measures

Primary Outcomes (1)

• BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years

  Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years.

  Through study completion, an average of 5 months

Study Arms (3)

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

EXPERIMENTAL

BCVA with handheld device with app.

Device: Phoropter; Device: Autorefractor

Manual Refraction

ACTIVE COMPARATOR

BCVA with phoropter

Device: Hand-held device supported by a mobile application

Automated Refraction

ACTIVE COMPARATOR

BCVA with autorefractoer

Device: Hand-held device supported by a mobile application

Interventions

Hand-held device supported by a mobile application DEVICE

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

Automated Refraction; Manual Refraction

Phoropter DEVICE

Manual refraction and ETDRS chart

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

Autorefractor DEVICE

Automated refraction

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

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EyeQue Corp.: lead

Study Sites (1)

United Medical Research Institute

Inglewood, California, 90301, United States

Location

MeSH Terms

Conditions

Refractive Errors; Astigmatism; Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: VP Science and Technology
• Organization: EyeQue

noam.sapiens@eyeque.com

5104558168

Study Officials

• James Peace, MD

  United Medical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 29, 2019
• Study Start: May 7, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 24, 2022
• Results First Posted: March 24, 2022

Record last verified: 2022-02

Locations

US (1)