MedTrace Logo

PMCF Retrospective Study Outcomes of a Premium Monofocal IOL

NCT04874376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2022-07-20

No results posted yet for this study

Summary

Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery.

The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.

Conditions

  • Cataract
  • Lens Opacities

Interventions

DEVICE

IOL implantation experimental (Isopure 1.2.3.)

Implantation of Premium Monofocal Isopure 12.3 with retrospective data collection

Sponsors & Collaborators

  • targomedGmbH

    collaborator INDUSTRY

  • Beaver-Visitec International, Inc.

    lead INDUSTRY

Principal Investigators

  • Gonzalo Bernabeu Arias, MD · HM Monteprincipe, HM Vallés, Madrid, Spain

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2022-01-12
Completion
2022-01-12

Countries

  • Spain

Study Locations

More Related Trials

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 NCT04874376 on ClinicalTrials.gov