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Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia

NCT05735990 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2023-02-21

No results posted yet for this study

Summary

The clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia.

Retrospective data from preoperative status up to 12 month postoperative status will be collected from patients that were implanted with Medicontur's 640PM intraocular lens:

* Preoperative status: Preoperative Screening and Baseline
* Surgery: IOL implantation
* M1: 1 month +/- 2 weeks postoperative follow-up
* M3: 3 months +/- 1 month postoperative follow-up
* M12: 12 months +/- 3 months postoperative follow-up

Conditions

  • Cataract
  • Presbyopia
  • Hyperopia
  • Myopia
  • Pseudophakia

Interventions

DEVICE

Intraocular lens

Aspheric hydrophilic acrylic IOL for implantation into the capsular bag

Sponsors & Collaborators

  • Medicontur Medical Engineering Ltd

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-27
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT05735990 on ClinicalTrials.gov