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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Refractive Errors, Astigmatism

Intervention / Treatment
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* Device: Hand-held device supported by a mobile application
* Device: Phoropter
* Device: Autorefractor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Refraction with a Hand-held Device Supported by Mobile App.<br>BCVA with handheld device with app. | Device: Phoropter<br>* Manual refraction and ETDRS chart<br>Device: Autorefractor<br>* Automated refraction<br>|
| Active Comparator: Manual Refraction<br>BCVA with phoropter | Device: Hand-held device supported by a mobile application<br>* Hand-held device supported by a mobile application to obtain refractive error of the eye.<br>|
| Active Comparator: Automated Refraction<br>BCVA with autorefractoer | Device: Hand-held device supported by a mobile application<br>* Hand-held device supported by a mobile application to obtain refractive error of the eye.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperopia, myopia