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

Not Applicable

Completed

Conditions: Refractive Errors
Astigmatism

Interventions: Device: Phoropter
Device: Hand-held device supported by a mobile application
Device: Autorefractor

Registration Number: NCT03929588

Lead Sponsor: EyeQue Corp.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 230

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Refraction with a Hand-held Device Supported by Mobile App.	Phoropter	BCVA with handheld device with app.
Manual Refraction	Hand-held device supported by a mobile application	BCVA with phoropter
Automated Refraction	Hand-held device supported by a mobile application	BCVA with autorefractoer
Refraction with a Hand-held Device Supported by Mobile App.	Autorefractor	BCVA with handheld device with app.

Primary Outcome Measures

Name	Time	Method
BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years	Through study completion, an average of 5 months	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.

Secondary Outcome Measures