Clinical Study to Evaluate Effectiveness of Digital Refraction

Not Applicable

Completed

• Conditions: Astigmatism; Myopia
• Interventions: Device: Digital refraction; Other: Manual Refraction

• Registration Number: NCT03502863
• Lead Sponsor: Visibly

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.

Study Timeline

• Study First Submitted: 2018-04-07
• Study First Submitted QC: 2018-04-17
• Study Start: 2018-04-19
• Study First Posted: 2018-04-19
• Primary Completion: 2018-07-06
• Study Completion: 2018-07-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Refraction	Digital refraction	Manual manifest refraction is performed by an eyesore specialist using a phoropter.
Digital refraction	Manual Refraction	Web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone

Primary Outcome Measures

Name	Time	Method
A digital refraction will be compared to standard manual refraction methods (using a phoropter) to the correlation of the two methods.	After the Day 1 Visits	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.

Trial Locations

Locations (3)

Site 03; 🇺🇸 Fort Lauderdale, Florida, United States

Site 02; 🇺🇸 Nashville, Tennessee, United States

Site 01; 🇺🇸 Harlingen, Texas, United States