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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929588
• Other study ID #: EYEQUE - 001
• Status: Completed
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: February 2022
• Source: EyeQue Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Refractive Errors

Intervention

Device:
• Hand-held device supported by a mobile application
Hand-held device supported by a mobile application to obtain refractive error of the eye.
• Phoropter
Manual refraction and ETDRS chart
• Autorefractor
Automated refraction

Locations

Country	Name	City	State
United States	United Medical Research Institute	Inglewood	California

Sponsors (1)

Lead Sponsor	Collaborator
EyeQue Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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