LFR-260 vs Traditional Phoropter in Visual Acuity Testing

Study Overview
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Brief Summary
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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.

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

Conditions
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Visual Acuity, Astigmatism, Anisometropia

Intervention / Treatment
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* Device: LFR-260 portable phoropter
* Device: Traditional phoropter (Standard of Care)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LFR-260<br>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<br>* Portable unit to evaluate visual refractive state of the patient<br>|
| Active Comparator: Traditional phoropter<br>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. | Device: Traditional phoropter (Standard of Care)<br>* Standard unit for evaluating visual refractive state of the patient<br>|

What is the study measuring?
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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 in subjects undergoing a full routine eye examination. | 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 | 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 | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular