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Clinical Study to Evaluate Effectiveness of Digital Refraction

Primary Purpose

Myopia, Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital refraction
Manual Refraction
Sponsored by
Visibly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myopia

Eligibility Criteria

22 Years - 55 Years (Adult)All SexesAccepts 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.

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.

Sites / Locations

  • Site 03
  • Site 02
  • Site 01

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital refraction

Manual Refraction

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 7, 2018
Last Updated
October 24, 2018
Sponsor
Visibly
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1. Study Identification

Unique Protocol Identification Number
NCT03502863
Brief Title
Clinical Study to Evaluate Effectiveness of Digital Refraction
Official Title
A Prospective Clinical Study to Evaluate the Effectiveness of Digital Refraction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
July 6, 2018 (Actual)
Study Completion Date
July 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Visibly

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital refraction
Arm Type
Experimental
Arm Description
Web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone
Arm Title
Manual Refraction
Arm Type
Active Comparator
Arm Description
Manual manifest refraction is performed by an eyesore specialist using a phoropter.
Intervention Type
Device
Intervention Name(s)
Digital refraction
Intervention Description
A web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone.
Intervention Type
Other
Intervention Name(s)
Manual Refraction
Intervention Description
Manual refraction and ETDRS chart
Primary Outcome Measure Information:
Title
A digital refraction will be compared to standard manual refraction methods (using a phoropter) to the correlation of the two methods.
Description
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.
Time Frame
After the Day 1 Visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 5. Subjects with Best Corrected Visual Acuity (BCVA) of 20/32 or better. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Lee
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Site 03
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Site 02
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Site 01
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States

12. IPD Sharing Statement

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Clinical Study to Evaluate Effectiveness of Digital Refraction

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