LFR-260 vs Traditional Phoropter in Visual Acuity Testing

Recruiting at 1 trial location

Overseen ByRaul Mihali

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Evolution Optiks Limited

Disqualifiers: Diabetes, Autoimmune, Pregnancy, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new vision testing device called LFR-260 to see if it works as well as the traditional tool used during routine eye exams. It measures how well you can see by comparing different lenses. The study involves people who are already getting their eyes checked.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the LFR-260 portable phoropter safe for use in humans?

The research articles do not provide specific safety data for the LFR-260 portable phoropter, but phoropters in general are widely accepted for clinical use in eye examinations, suggesting they are considered safe for human use.¹ ² ³ ⁴ ⁵

How does the LFR-260 portable phoropter treatment differ from traditional eye examination methods?

The LFR-260 portable phoropter is unique because it offers a more integrated and potentially automated approach to eye examinations, which may streamline the process compared to traditional phoropters that require separate autorefraction and subjective refraction steps.² ⁴ ⁵ ⁶ ⁷

What data supports the effectiveness of the treatment involving the LFR-260 portable phoropter?

Research shows that phoropters, like the LFR-260, are reliable for eye exams and visual function assessments. Newer technologies, including portable devices, have shown promise in improving the accuracy and reliability of vision tests compared to traditional methods.¹ ² ⁵ ⁸ ⁹

Are You a Good Fit for This Trial?

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.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Device Testing

Participants undergo visual acuity testing using both the LFR-260 and traditional phoropter devices

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate feedback or issues post-testing

1 day

What Are the Treatments Tested in This Trial?

Interventions

Informed Consent
LFR-260 portable phoropter
Randomization
Routine Eye Examination
Screening
Traditional phoropter (Standard of Care)
Visual Acuity Testing

How Is the Trial Designed?

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1: LFR-260 first, then traditional phoropterExperimental Treatment2 Interventions

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.

Group II: Group II: Traditional Phoropter first, then LFR-260Active Control2 Interventions

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.