LFR-260 vs Traditional Phoropter in Visual Acuity Testing

NCT05259163 | Completed Results FDA Device

• 1 other identifier: LFR-260-2021
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

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.

Conditions

Visual Acuity; Astigmatism; Anisometropia

Keywords

Ocular

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patient Satisfaction Survey

  Day 0

• Provider Satisfaction Survey

  Day 0

Study Arms (2)

Group 1: LFR-260 first, then traditional phoropter

EXPERIMENTAL

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; Device: Traditional phoropter (SOC)

Group II: Traditional Phoropter first, then LFR-260

ACTIVE COMPARATOR

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; Device: Traditional phoropter (SOC)

Interventions

LFR-260 portable phoropter DEVICE

Portable unit to evaluate visual refractive state of the patient

Group 1: LFR-260 first, then traditional phoropter; Group II: Traditional Phoropter first, then LFR-260

Traditional phoropter (SOC) DEVICE

Standard unit for evaluating visual refractive state of the patient

Group 1: LFR-260 first, then traditional phoropter; Group II: Traditional Phoropter first, then LFR-260

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evolution Optiks Limited: lead

Study Sites (2)

MCPHS

Worcester, Massachusetts, 01608, United States

Location

Gold Coast Optometric Vision

Oyster Bay, New York, 11771, United States

Location

MeSH Terms

Conditions

Astigmatism; Anisometropia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Raul Mihali
• Organization: Evolution Optiks

raul.mihali@evolutionoptiks.com

2039815480

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: The investigational product was compared to the traditional phoropter. Subjects were randomized to the order of testing.

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 28, 2022
• Study Start: June 7, 2022
• Primary Completion: January 6, 2023
• Study Completion: January 6, 2023
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-08

Locations

US (2)