CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 112 enrolled
Drug / intervention
LFR-260 portable phoropter +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05259163
NCT05259163N/ACompleted
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An Evaluation of the LFR-260 Against a Traditional Phoropter in Visual Acuity Testing

Evolution Optiks Limited·interventional·Posted Feb 28, 2022·Updated Sep 25, 2024

In Brief

A clinical study evaluating LFR-260 portable phoropter and Traditional phoropter (SOC) for Visual Acuity and 2 related conditions. Completed, enrolled 112 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVisual Acuity, Astigmatism, Anisometropia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedFeb 28, 2022
Enrollment StartJun 7, 2022
Primary CompletionJan 6, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.3 years ago

Interventions

LFR-260 portable phoropterdevice

Portable unit to evaluate visual refractive state of the patient

Traditional phoropter (SOC)device

Standard unit for evaluating visual refractive state of the patient