Clinical Study to Evaluate Effectiveness of Digital Refraction

Visibly102 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

102

Conditions

Myopia Astigmatism

Interventions

Digital refractionDEVICE

A web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone.

Manual RefractionOTHER

Manual refraction and ETDRS chart

Eligibility

Sex: ALLMin age: 22 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject must be between 22 and 55 years of age at the time of consent. 2. Subject must have a refractive error 1. With no greater than -3.00 D myopia and -2.00 D astigmatism in either eye. 2. 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: 1. Subjects with diabetes mellitus. 2. Subjects using ophthalmic or systemic corticosteroids. 3. Subjects with autoimmune conditions. 4. Subjects with active corneal or conjunctival infection. 5. Subjects with active corneal, conjunctival, or intraocular inflammation (ie, uveitis). 6. Subjects with diabetic retinopathy. 7. Subjects with glaucoma or ocular hypertension. 8. Subjects with macular degeneration. 9. Subjects with previous ocular surgery. 10. Subjects on antihyperglycemic agents; corticosteroids; hydroxychloroquine (Plaquenil) and chloroquine (Aralen); tamoxifen (Nolvadex). 11. Pregnancy 12. Subjects who, in the judgment of the Investigator, may be inappropriate for the intended study procedures.

Locations (3)

Site 03

Fort Lauderdale, Florida, United States

Site 02

Nashville, Tennessee, United States

Site 01

Harlingen, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: After the Day 1 Visits

Data from ClinicalTrials.gov

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