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PMCF Study on EDOF (Isopure) vs Monofocal (Micropure) IOL

NCT04249492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-11-21

No results posted yet for this study

Summary

Multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of an enhanced depth of focus (EDOF) IOL with the outcomes obtained with a monofocal lens. Implantation of the IOLs is bilaterally.

Conditions

  • Cataract
  • Lens Opacities

Interventions

DEVICE

IOL implantation experimental (Isopure 1.2.3.)

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> intermediate \> near

DEVICE

IOL implantation active comparator (Micropure 1.2.3.)

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> near \> intermediate

Sponsors & Collaborators

  • targomedGmbH

    collaborator INDUSTRY

  • Beaver-Visitec International, Inc.

    lead INDUSTRY

Principal Investigators

  • Florian Kretz, MD · Augentagesklinik Rheine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-11
Primary Completion
2023-02-23
Completion
2024-04-18

Countries

  • Austria
  • Czechia
  • Germany
  • Ireland
  • Philippines
  • Spain

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 NCT04249492 on ClinicalTrials.gov