Status:
UNKNOWN
Evaluation of Efficacy and Long-term Safety for Lucidis Instant Focus© - PMCF Study Protocol
Lead Sponsor:
SAV-IOL SA
Collaborating Sponsors:
CEISO
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Brief 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 thu...
Detailed 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 crys...
Eligibility Criteria
Inclusion
- adult patients (≥18 years)
- having agreed to take part in the study and complete post-operative follow-up requirements (by having signed the information leaflet-informed consent form);
- with;
- for whom the physician made the decision to implant a Lucidis
Exclusion
- 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 study endpoints;
- 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 a clinical investigation (e.g. mentally ill or handicapped person)
Key Trial Info
Start Date :
May 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04761276
Start Date
May 21 2021
End Date
October 1 2022
Last Update
May 27 2021
Active Locations (1)
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1
Hôpital Jules Gonin
Lausanne, Switzerland, 1004