LFR-260 vs Traditional Phoropter in Visual Acuity Testing

Evolution Optiks

Status: Completed

Conditions: Astigmatism; Anisometropia; Visual Acuity

Treatments: Device: LFR-260 portable phoropter; Device: Traditional phoropter (SOC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05259163

LFR-260-2021

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Group 1: LFR-260 first, then traditional phoropter

Experimental group

Description:

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.

Treatment:

Device: Traditional phoropter (SOC)

Device: LFR-260 portable phoropter

Group II: Traditional Phoropter first, then LFR-260

Active Comparator group

Description:

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.

Treatment:

Device: Traditional phoropter (SOC)

Device: LFR-260 portable phoropter