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LFR-260 vs Traditional Phoropter in Visual Acuity Testing

NCT05259163 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-09-25

Study results available
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Summary

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.

Conditions

  • Visual Acuity
  • Astigmatism
  • Anisometropia

Interventions

DEVICE

LFR-260 portable phoropter

Portable unit to evaluate visual refractive state of the patient

DEVICE

Traditional phoropter (SOC)

Standard unit for evaluating visual refractive state of the patient

Sponsors & Collaborators

  • Evolution Optiks Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2023-01-06
Completion
2023-01-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05259163 on ClinicalTrials.gov