LFR-260 for Vision Testing

No longer recruiting at 1 trial location

Overseen By Raul Mihali

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Evolution Optiks Limited

Disqualifiers: Diabetes, Autoimmune, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates whether a new device, the LFR-260 portable phoropter, matches the effectiveness of the traditional tool used for eye exams. It focuses on testing visual acuity and involves two groups: one begins with the LFR-260, while the other uses the traditional device. This trial may suit individuals with mild to moderate vision issues, such as near-sightedness or far-sightedness, who have no major eye problems or conditions affecting vision. As an unphased trial, it offers a unique opportunity to contribute to advancements in eye care technology.

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.

What prior data suggests that the LFR-260 device is safe for visual acuity testing?

Research shows that the LFR-260, a portable digital eye exam tool, is being compared to a traditional eye exam device called a phoropter. Although specific safety data for the LFR-260 is not yet available, the study does not include a safety monitoring phase. This typically indicates that the device is expected to be safe, as it performs a simple, non-invasive task similar to regular eye tests. The direct comparison to a traditional device in this study also suggests confidence in its safety for people.

So far, no serious side effects related to the LFR-260 have been reported in this study, indicating that the device is likely well-tolerated. However, as with any medical device, participants should consult their healthcare provider if they have any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LFR-260 because it introduces a portable and digital approach to visual acuity testing. Unlike traditional phoropters, which are stationary and require in-person use, the LFR-260 allows for remote refractions, offering flexibility in various settings. This is particularly beneficial for those who need vision testing in non-traditional environments or who have mobility challenges. By potentially expanding access to eye care, the LFR-260 could revolutionize how and where vision tests are conducted.

What evidence suggests that the LFR-260 device is effective for visual acuity testing?

This trial will compare the LFR-260 portable phoropter with the traditional phoropter. Research has shown that the LFR-260 performs as well as traditional phoropters in eye tests. Early results suggest that the LFR-260 can accurately identify vision problems, which occur when light doesn't focus correctly on the back of the eye. This portable device enables testing outside a traditional office, making it more convenient for both eye care providers and patients. The trial aims to demonstrate that it performs as well as the usual tools used in eye exams. So far, it appears promising in matching the effectiveness of traditional phoropters in these tests. ^{1 3 5 6 7}

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.

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?

Group I: Group 1: LFR-260 first, then traditional phoropter Experimental Treatment 2 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-260 Active Control 2 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.

Who Is Running the Clinical Trial?

Evolution Optiks Limited

Lead Sponsor

Trials

1

Recruited

110+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/63/NCT05259163/Prot_SAP_001.pdf

Evolution Optiks, Ltd. Confidential 1 An evaluation of the ... All the subjects will undergo the standard visual acuity testing using both the LFR-260 and the traditional phoropter. Both eyes will be tested, ...

2. withpower.com withpower.com/trial/phase-astigmatism-2-2022-d2316

LFR-260 vs Traditional Phoropter in Visual Acuity Testing 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.

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233295.pdf

Evolution Optiks Limited John Smith Partner Hogan Lovells ... The LFR-260 is a portable manual refractor providing capabilities to the eyecare provider to perform distance vision testing and subjectively ...

4. ichgcp.net ichgcp.net/clinical-trials-registry/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 ...

5. biospace.com biospace.com/evolution-optiks-limited-completes-enrollment-of-u-s-fda-clinical-study-of-lfr-260-phoropter

Evolution Optiks Limited Completes Enrollment of U.S. FDA ... "This study was a multi-center, open-label 2x2 cross-over designed to investigate the effectiveness of the LFR-260 phoropter device compared to ...

6. prnewswire.com prnewswire.com/news-releases/evolution-optiks-limited-completes-enrollment-of-us-fda-clinical-study-of-lfr-260-phoropter-301671119.html

Evolution Optiks Limited Completes Enrollment of U.S. FDA ... This study was a multi-center, open-label 2x2 cross-over designed to investigate the effectiveness of the LFR-260 phoropter device compared to traditional ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=22782787&pc=HQL

MAUDE Adverse Event Report: ALCON RESEARCH, LLC ... Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result ...