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

A Clinical Validation Study to Evaluate the Performance of a Hand-held Device Supported by a Mobile Application Compared With Standard Eye Care Diagnostic Devices in Measuring Refractive Error of the Eye

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Astigmatism
• Intervention / Treatment: Device: Phoropter; Device: Autorefractor; Device: Hand-held device supported by a mobile application

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.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Inglewood, California, United States, 90301
      • United Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Refraction with a Hand-held Device Supported by Mobile App.; BCVA with handheld device with app.	Device: Phoropter; Manual refraction and ETDRS chart; Device: Autorefractor; Automated refraction
ACTIVE_COMPARATOR: Manual Refraction; BCVA with phoropter	Device: Hand-held device supported by a mobile application; Hand-held device supported by a mobile application to obtain refractive error of the eye.
ACTIVE_COMPARATOR: Automated Refraction; BCVA with autorefractoer	Device: Hand-held device supported by a mobile application; Hand-held device supported by a mobile application to obtain refractive error of the eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: EyeQue Corp.
• Investigators: Principal Investigator: James Peace, MD, United Medical Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2019
• Primary Completion (ACTUAL): March 31, 2020
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (ACTUAL): April 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: myopia; hyperopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EYEQUE - 001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No