Clinical Study to Evaluate Effectiveness of Digital Refraction

Visibly

Status: Completed

Conditions: Myopia; Astigmatism

Treatments: Device: Digital refraction; Other: Manual Refraction

Study type: Interventional

Funder types: Industry

Identifiers

NCT03502863

OPT-1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 22 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

3. 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Digital refraction

Experimental group

Description:

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

Treatment:

Other: Manual Refraction

Manual Refraction

Active Comparator group

Description:

Manual manifest refraction is performed by an eyesore specialist using a phoropter.

Treatment:

Device: Digital refraction