LFR-260 vs Traditional Phoropter in Visual Acuity Testing

An Evaluation of the LFR-260 Against a Traditional Phoropter in Visual Acuity Testing

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Visual Acuity; Anisometropia
• Intervention / Treatment: Device: LFR-260 portable phoropter; Device: Traditional phoropter (SOC)

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01608
      • MCPHS
  • New York
    • Oyster Bay, New York, United States, 11771
      • Gold Coast Optometric Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: LFR-260 first, then traditional phoropter; The LFR-260 was administered first in this group, followed by the traditional phoropter. 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.	Device: LFR-260 portable phoropter; Portable unit to evaluate visual refractive state of the patient; Device: Traditional phoropter (SOC); Standard unit for evaluating visual refractive state of the patient
Active Comparator: Group II: Traditional Phoropter first, then LFR-260; The traditional phoropter was administered first in this group, followed by the traditional phoropter. The traditional phoropter is intended to be used for distance vision testing in any environment. 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.	Device: LFR-260 portable phoropter; Portable unit to evaluate visual refractive state of the patient; Device: Traditional phoropter (SOC); Standard unit for evaluating visual refractive state of the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of LFR260 on Visual Acuity Test	Agreement of LFR-260 (investigational device) to traditional phoropter (comparator device) when applied in visual acuity test (eye chart test) in subjects undergoing a full routine eye examination. Agreement will be determined by demonstrating that the LFR-260 is within 0.5D (+/-) in measuring sphere and cylinder results and within 10 degrees for axis results among subjects with low astigmatism and within 5 degrees among subjects with moderate to high astigmatism from the traditional phoropter.	Day 0
Precision of LFR260 in Repeated Testing	Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Survey	4-question survey (1=worst; 5=best) given to patients to determine satisfaction with LFR-260 device Quad view. Q1: Was the LFR-260 device Quad view comfortable to use for your eye exam? (1=very uncomfortable - 5=very comfortable) Q2: Did the LFR-260 Quad view feel the same as the traditional phoropter when taking your eye exam? (1=LFR-260 definitely more uncomfortable - 5=LFR-260 definitely more comfortable) Q3: Did you prefer to read the eye chart using the LFR-260 device Quad view or traditional phoropter? (1=definitely prefer phoropter - 5=definitely prefer LFR-260) Q4: If taking an eye exam in the future, would you prefer your doctor use the LFR-260 Quad view or traditional phoropter? (1=definitely prefer phoropter - 5=definitely prefer LFR-260)	Day 0
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. Q1: LFR-260 device performed as expected according to the Instructions for Use (IFU)? (1=definitely did not - 5=definitely) Q2: LFR-260 device was easy to use? (1=very difficult to use - 5=very easy to use) Q3: LFR-260 device was intuitive to operate? (1=definitely counterintuitive - 5=very intuitive) Q4: LFR-260 was more or less convenient to use than the phoropter? (1=definitely less convenient- 5=definitely more convenient)	Day 0

Collaborators and Investigators

• Sponsor: Evolution Optiks Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Actual): January 6, 2023
• Study Completion (Actual): January 6, 2023

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Ocular
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Anisometropia
• Other Study ID Numbers: LFR-260-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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.: Yes