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PMCF Study on Monofocal Toric IOL (PODEYE TORIC)

NCT04744467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-08-20

No results posted yet for this study

Summary

This is a single-center, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (study no. PHY2101, ClinicalTrials.gov ID: NCT04744467)

Conditions

  • Cataract
  • Lens Opacities
  • Astigmatism

Interventions

DEVICE

IOL implantation experimental

Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be receive an implantation with the monofocal parent lens PODEYE (PhysIOL sa/nv, Liège, Belgium).

Sponsors & Collaborators

  • targomedGmbH

    collaborator INDUSTRY

  • Beaver-Visitec International, Inc.

    lead INDUSTRY

Principal Investigators

  • Pavel Stodulka, MD · Gemini Eye Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2023-06-08
Completion
2023-12-19

Countries

  • Czechia

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 NCT04744467 on ClinicalTrials.gov