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Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF in Comparison With a Multifocal and a Monofocal IOL

NCT04005651 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-04-19

No results posted yet for this study

Summary

The objectives of the Post-Market Follow-up (PMCF) clinical investigation are to determine the safety and performance of a hydrophobic trifocal intraocular lens POD L GF in comparison with two comparator lenses: another multifocal intraocular lens (Johnson \& Johnson TECNIS Symfony® Extended Range of Vision IOL); and a monofocal intraocular lens (Alcon AcrySof® IQ Monofocal IOL) through one year of post-operative assessments.

Conditions

  • Aphakia, Postcataract
  • Cataract; Eye Disease

Interventions

DEVICE

POD L GF IOL

Cataractous lens will be removed in the study eyes and the POD L GF IOL will be implanted in the capsular bag

DEVICE

Symfony® IOL

Cataractous lens will be removed in the study eyes and the Symfony® IOL will be implanted in the capsular bag

DEVICE

AcrySof® IOL

Cataractous lens will be removed in the study eyes and the AcrySof® IOL will be implanted in the capsular bag

Sponsors & Collaborators

  • Beaver-Visitec International, Inc.

    lead INDUSTRY

Principal Investigators

  • Christophe Pagnoulle · PhysIOL s.a.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2022-07-27
Completion
2022-11-29

Countries

  • France
  • Germany
  • 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 NCT04005651 on ClinicalTrials.gov