Clinical Study to Evaluate Effectiveness of Digital Refraction

Study Overview
=================
Brief Summary
-----------------
Prospective, comparative, randomized, non-masked clinical study to compare the a digital refraction with LogMAR VA testing utilizing trial lenses, to standard manual refraction using a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement.

Detailed Description
-----------------
A digital refraction tool is a device meant to measure visual acuity and to subjectively measure refractive value for a patient's eye for the conditions of myopia and astigmatism. It is intended for adults aged 22 to 55 years that have no prior correction with up to 3.00 diopters (D) of myopia and up to 2.00 D of astigmatism, or those with prior correction up to 10.00 D of myopia and require an over-refraction of no more than 2.75 D. LogMAR (ETDRS) chart to measure visual acuity. The manual manifest refraction is performed by an eyecare specialist using a phoropter. The LogMAR Visual Acuity chart is used to measure visual acuity. The manual refraction will be used in this study for obtaining the refractive error of each eye.

Official Title
-----------------
A Prospective Clinical Study to Evaluate the Effectiveness of Digital Refraction

Conditions
-----------------
Myopia, Astigmatism

Intervention / Treatment
-----------------
* Device: Digital refraction
* Other: Manual Refraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be between 22 and 55 years of age at the time of consent. Subject must have a refractive error With no greater than -3.00 D myopia and -2.00 D astigmatism in either eye. With prior correction of no greater than -10.00 D myopia and requiring over-refraction of no more than 2.75 D in either eye. 5. Subjects with Best Corrected Visual Acuity (BCVA) of 20/32 or better. Exclusion Criteria: Subjects with diabetes mellitus. Subjects using ophthalmic or systemic corticosteroids. Subjects with autoimmune conditions. Subjects with active corneal or conjunctival infection. Subjects with active corneal, conjunctival, or intraocular inflammation (ie, uveitis). Subjects with diabetic retinopathy. Subjects with glaucoma or ocular hypertension. Subjects with macular degeneration. Subjects with previous ocular surgery. Subjects on antihyperglycemic agents; corticosteroids; hydroxychloroquine (Plaquenil) and chloroquine (Aralen); tamoxifen (Nolvadex). Pregnancy Subjects who, in the judgment of the Investigator, may be inappropriate for the intended study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital refraction<br>Web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone | Other: Manual Refraction<br>* Manual refraction and ETDRS chart<br>|
| Active Comparator: Manual Refraction<br>Manual manifest refraction is performed by an eyesore specialist using a phoropter. | Device: Digital refraction<br>* A web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A digital refraction will be compared to standard manual refraction methods (using a phoropter) to the correlation of the two methods. | The difference between testing methods (Manual Refraction with a phoropter versus a digital refraction test) will be analyzed by mean, standard deviation, and 95% confidence interval overall and by the levels of refractive correction (sphere, cylinder, MRSE) and for visual acuity using LogMAR format. | After the Day 1 Visits |