NCT05259163

LFR-260 vs Traditional Phoropter in Visual Acuity Testing

An Evaluation of the LFR-260 Against a Traditional Phoropter in Visual Acuity Testing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Evolution Optiks Limited · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-06-07
• Primary completion: 2023-01-06
• Completion: 2023-01-06
• First posted: 2022-02-28
• Last updated: 2024-09-25
• Results posted: 2024-09-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study