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PMCF Study on Comparison of EDOF Lenses (Switzerland)

NCT05235139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2024-05-09

No results posted yet for this study

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).

Conditions

  • Cataract
  • Lens Opacities

Interventions

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

Sponsors & Collaborators

  • targomedGmbH

    collaborator INDUSTRY

  • Beaver-Visitec International, Inc.

    lead INDUSTRY

Principal Investigators

  • Kristof Vandekerkchove, MD · Eye center Vista Alpina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2023-08-22
Completion
2023-08-22

Countries

  • Switzerland

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 NCT05235139 on ClinicalTrials.gov