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Evaluation of Efficacy and Long-term Safety for Lucidis Instant Focus© - PMCF Study Protocol

NCT04761276 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2021-05-27

No results posted yet for this study

Summary

The objectives of the study is to evaluate efficacy and long-term safety of the Lucidis lens. Through this study, the objective is to obtain an up-to-date clinical evaluation of the medical device thus supplementing data from experimental trials. Clinical and functional changes in the implanted eyes among a patient population in which the opaque crystalline lens resulting from cataract was removed and replaced by a Lucidis IOL will be described.

Conditions

  • Cataract

Interventions

DEVICE

Surgical implantation of intra ocular lens

Cataract surgery may be indicated when the cataract reduces visual function to a level that interferes with everyday activities of the patient leading the patient to desire a surgical intervention to improve its vision.

Sponsors & Collaborators

  • CEISO

    collaborator INDUSTRY

  • SAV-IOL SA

    lead INDUSTRY

Principal Investigators

  • Kate Hashemi, Pr · Institut jules gonin

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Switzerland

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 NCT04761276 on ClinicalTrials.gov