NCT05235139

PMCF Study on Comparison of EDOF Lenses (Switzerland)

Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of a Premium Monofocal Intraocular Lens (IOL) in Comparison to an EDOF Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Beaver-Visitec International, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

Single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of a premium monofocal intraocular lens (PhysIOL ISOPURE 1.2.3.) with clinical data obtained in a control group implanted with an EDOF IOL (Alcon Acrysof IQ Vivity).

Detailed description

This is a single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of premium monofocal intraocular lenses (PhysIOL ISOPURE 1.2.3.) or EDOF lenses (Alcon Acrysof IQ Vivity). The patients will be randomized in a 1:1 ratio to receive the study or control lenses. Both IOLs, investigational device and control device, are CE approved and commercially available in the countries this clinical investigation is being carried out. The investigational device and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient. The device under investigation (ISOPURE 1.2.3.) is a hydrophobic, glistening-free, acrylic premium monofocal intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens (Alcon Acrysof IQ Vivity) is a non-diffractive Extended Vision Posterior Chamber IOL. The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development. Subjects participating in the trial will attend a total of 6 study visits (1 preoperative, 1 operative and 4 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically. Primary and secondary endpoint data will be collected at the 120-180 days follow up visit.

Conditions

• Cataract
• Lens Opacities

Interventions

Type	Name	Description
DEVICE	IOL implantation experimental (ISOPURE 1.2.3.)	Implantation of premium monofocal IOL ISOPURE 1.2.3.
DEVICE	IOL implantation active comparator (Acrysof Vivity)	Implantation of EDOF IOL Acrysof Vivity

Timeline

• Start date: 2022-03-09
• Primary completion: 2023-08-22
• Completion: 2023-08-22
• First posted: 2022-02-11
• Last updated: 2024-05-09

Locations

1 site across 1 country: Switzerland