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

Last updated: May 25, 2021
Sponsor: SAV-IOL SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Vision Loss

Eye Disease

Treatment

N/A

Clinical Study ID

NCT04761276
LUCIDIS2021
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult patients (≥18 years)
  • having agreed to take part in the study and complete post-operative follow-uprequirements (by having signed the information leaflet-informed consent form);
  • with;
  • for whom the physician made the decision to implant a Lucidis

Exclusion

Exclusion Criteria:

  • patient included in an interventional therapeutic trial at the time of inclusion;
  • patient presenting contraindications for the implantation of an intraocular lens;
  • patient presenting an ophthalmic disorder liable to interfere with the studyendpoints;
  • patient presenting with an astigmatism ≥1.0 D;
  • patient refusing or unable to comply with the follow-up procedures in the study (patient unable to be reached by telephone, liable to be lost to follow-up, etc.);
  • History of previous intraocular surgery in the study eye in the previous 6 months;
  • patient is pregnant, breast-feeding or unable to make the decision to participate in aclinical investigation (e.g. mentally ill or handicapped person)

Study Design

Total Participants: 120
Study Start date:
May 21, 2021
Estimated Completion Date:
October 31, 2022

Study Description

Refractory function in patients with a cataract is mainly restored by implanting intra-ocular lenses (IOL) destined to replace the crystalline lens. While new surgical techniques for removing the crystalline lens have been developed, these lenses have been considerably perfected to resemble the natural crystalline lens as closely as possible.

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.

Connect with a study center

  • Hôpital Jules Gonin

    Lausanne, 1004
    Switzerland

    Active - Recruiting

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