Clinical Study to Evaluate Effectiveness of Digital Refraction

A Prospective Clinical Study to Evaluate the Effectiveness of Digital Refraction

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Other: Manual Refraction; Device: Digital refraction

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33324
      • Site 03
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Site 02
  • Texas
    • Harlingen, Texas, United States, 78550
      • Site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Visibly
• Investigators: Study Director: S Lee, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): July 6, 2018
• Study Completion (Actual): July 6, 2018

Study Registration Dates

• First Submitted: April 7, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: OPT-1001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No