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LFR-260 vs Traditional Phoropter in Visual Acuity Testing

Primary Purpose

Visual Acuity, Astigmatism, Anisometropia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LFR-260 portable phoropter
Traditional phoropter (Standard of Care)
Sponsored by
Evolution Optiks Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Visual Acuity focused on measuring Ocular

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. The participant or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
  2. The participant is a male or female between the ages of 12 and 65 (inclusive).
  3. The participant has no more than mild to moderate far-sightedness, near-sightedness, astigmatism or anisometropia.
  4. The participant is free of ocular and systemic abnormalities that might affect visual functions.

Exclusion Criteria:

  1. The participant has diabetes mellitus (Type 1 or 2).
  2. The participant has an autoimmune condition.
  3. The participant is pregnant (self-reported).
  4. The participant has an active corneal or conjunctival infection.
  5. The participant has an active corneal, conjunctival, or intraocular inflammation (i.e. - uveitis).
  6. The participant has diabetic retinopathy.
  7. The participant has glaucoma or ocular hypertension.
  8. The participant has macular degeneration.
  9. The participant has had a previous ocular surgery.
  10. The participant has ocular and systemic diseases or abnormalities that might affect visual functions.
  11. The participant has a history of amblyopia, strabismus, or any other binocular vision abnormality.
  12. The participant has a history of AMD (age macular degeneration).
  13. The participant is a prisoner, a transient or has been treated for alcohol and/or drug abuse in an inpatient substance abuse program within 6 months prior to proposed study enrolment.
  14. The participant will not be able to complete questionnaires.
  15. The participant is currently in an investigational study for a similar purpose.
  16. The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures.

Sites / Locations

  • MCPHS
  • Gold Coast Optometric Vision

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LFR-260

Traditional phoropter

Arm Description

The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions during eye exams.

The traditional phoropter is intended to be used for distance vision testing in any environment. The traditional phoropter is an application-controlled instrument providing the same subjective refraction capabilities for distance vision testing as the standard of care eye examination including sphere, cylinder, and axis.

Outcomes

Primary Outcome Measures

Effectiveness of LFR260 on Visual Acuity test
Agreement of LFR-260 (investigational device) to traditional phoropter (comparator device) when applied in visual acuity test in subjects undergoing a full routine eye examination.
Precision of LFR260 in repeated testing
Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260.

Secondary Outcome Measures

Patient Satisfaction Survey
4-question survey (1=worst; 5=best) given to patients to determine satisfaction with LFR-260 device Quad view
Provider Satisfaction Survey
4-question survey (1=worst; 5=best) given to eye care provider to determine satisfaction with LFR-260 related to usability, convenience

Full Information

First Posted
February 9, 2022
Last Updated
April 25, 2023
Sponsor
Evolution Optiks Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05259163
Brief Title
LFR-260 vs Traditional Phoropter in Visual Acuity Testing
Official Title
An Evaluation of the LFR-260 Against a Traditional Phoropter in Visual Acuity Testing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
January 6, 2023 (Actual)
Study Completion Date
January 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evolution Optiks Limited

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to establish if LFR-260 (investigational device) is not inferior in effectiveness to a traditional phoropter (control device) when applied in visual acuity test in subjects undergoing a full routine eye examination. LFR-260 proposes to provide information of the visual capabilities of the patient. The test will be provided and supervised by a qualified eye care provider. The informed consent, screening, randomization (into the order of visual test device used), (visual) device testing (to include precision testing, remote and offsite testing) will all occur at a single visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Acuity, Astigmatism, Anisometropia
Keywords
Ocular

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LFR-260
Arm Type
Experimental
Arm Description
The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions during eye exams.
Arm Title
Traditional phoropter
Arm Type
Active Comparator
Arm Description
The traditional phoropter is intended to be used for distance vision testing in any environment. The traditional phoropter is an application-controlled instrument providing the same subjective refraction capabilities for distance vision testing as the standard of care eye examination including sphere, cylinder, and axis.
Intervention Type
Device
Intervention Name(s)
LFR-260 portable phoropter
Intervention Description
Portable unit to evaluate visual refractive state of the patient
Intervention Type
Device
Intervention Name(s)
Traditional phoropter (Standard of Care)
Intervention Description
Standard unit for evaluating visual refractive state of the patient
Primary Outcome Measure Information:
Title
Effectiveness of LFR260 on Visual Acuity test
Description
Agreement of LFR-260 (investigational device) to traditional phoropter (comparator device) when applied in visual acuity test in subjects undergoing a full routine eye examination.
Time Frame
Day 0
Title
Precision of LFR260 in repeated testing
Description
Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Patient Satisfaction Survey
Description
4-question survey (1=worst; 5=best) given to patients to determine satisfaction with LFR-260 device Quad view
Time Frame
Day 0
Title
Provider Satisfaction Survey
Description
4-question survey (1=worst; 5=best) given to eye care provider to determine satisfaction with LFR-260 related to usability, convenience
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The participant or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form. The participant is a male or female between the ages of 12 and 65 (inclusive). The participant has no more than mild to moderate far-sightedness, near-sightedness, astigmatism or anisometropia. The participant is free of ocular and systemic abnormalities that might affect visual functions. Exclusion Criteria: The participant has diabetes mellitus (Type 1 or 2). The participant has an autoimmune condition. The participant is pregnant (self-reported). The participant has an active corneal or conjunctival infection. The participant has an active corneal, conjunctival, or intraocular inflammation (i.e. - uveitis). The participant has diabetic retinopathy. The participant has glaucoma or ocular hypertension. The participant has macular degeneration. The participant has had a previous ocular surgery. The participant has ocular and systemic diseases or abnormalities that might affect visual functions. The participant has a history of amblyopia, strabismus, or any other binocular vision abnormality. The participant has a history of AMD (age macular degeneration). The participant is a prisoner, a transient or has been treated for alcohol and/or drug abuse in an inpatient substance abuse program within 6 months prior to proposed study enrolment. The participant will not be able to complete questionnaires. The participant is currently in an investigational study for a similar purpose. The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures.
Facility Information:
Facility Name
MCPHS
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
Gold Coast Optometric Vision
City
Oyster Bay
State/Province
New York
ZIP/Postal Code
11771
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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LFR-260 vs Traditional Phoropter in Visual Acuity Testing

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