ClinicalTrials.Veeva

Menu

Clinical Study to Evaluate Effectiveness of Digital Refraction

V

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)

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

Trial contacts and locations

3

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems