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Completed

NCT Number: NCT05259163

LFR-260 vs 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.

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Key information

Conditions

Visual Acuity Anisometropia Astigmatism Eye Diseases Refractive Errors

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MCPHS, Worcester, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LFR-260 portable phoropter

Device

Portable unit to evaluate visual refractive state of the patient

Traditional phoropter (SOC)

Device

Standard unit for evaluating visual refractive state of the patient

Primary outcomes

  1. Effectiveness of LFR260 on Visual Acuity Test

    Time frame: Day 0

    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.

  2. Precision of LFR260 in Repeated Testing

    Time frame: Day 0

    Precision testing will also be conducted to confirm repeatability and reproducibility of the LFR-260.

Secondary outcomes

  1. Patient Satisfaction Survey

    Time frame: Day 0

    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)

  2. Provider Satisfaction Survey

    Time frame: Day 0

    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)

Sponsors and collaborators

Lead sponsor

Evolution Optiks Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2022
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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