Clinical Study to Evaluate Effectiveness of Digital Refraction

NCT03502863 | Completed FDA Device

• 1 other identifier: OPT-1001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

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.

Conditions

Myopia; Astigmatism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Digital refraction

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Device: Digital refraction

Interventions

Digital refraction DEVICE

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

Manual Refraction

Manual Refraction OTHER

Manual refraction and ETDRS chart

Digital refraction

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• \. Subjects with Best Corrected Visual Acuity (BCVA) of 20/32 or better.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Visibly: lead

Study Sites (3)

Site 03

Fort Lauderdale, Florida, 33324, United States

Location

Site 02

Nashville, Tennessee, 37215, United States

Location

Site 01

Harlingen, Texas, 78550, United States

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• S Lee

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2018
• First Posted: April 19, 2018
• Study Start: April 19, 2018
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

US (3)