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PMCF Retrospective Study Outcomes of a Monofocal Toric Intraocular Lens

NCT05055076 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2022-08-23

No results posted yet for this study

Summary

This is a monocentric retrospective, open-label clinical study in patients after unilateral or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC and executed only with standard of care examinations.

The investigational device is CE approved. The investigational device and all study products, including the devices used for the study examinations, have been used within the intended use specifications from the manufacturer. In addition, there were no invasive or other burdening examinations.

The investigator is an accredited and experienced cataract surgeon and researcher.

The primary endpoint is to determine rotational stability in a minimum of 120 eyes of patients with PODEYE TORIC IOL implantation after cataract surgery. Patients will be enrolled for the documentation and evaluation of retrospective data up to 6 months postoperatively.

Conditions

  • Cataract
  • Lens Opacities
  • Astigmatism

Interventions

DEVICE

PODEYE TORIC

Patients will be contacted consecutively and will be enrolled after the patient informed leaflet has been given to them and after obtaining their consent to the scientific use of their data collected retrospectively (preoperative, surgery, postoperative routine visits). Patients will only be enrolled after the routine 4-6 months visit has been performed.

Sponsors & Collaborators

  • Beaver-Visitec International, Inc.

    lead INDUSTRY

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2021-12-14
Completion
2021-12-14

Countries

  • France

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 NCT05055076 on ClinicalTrials.gov