Clinical trial NCT04761276: Evaluation of Efficacy and Long-term Safety for Lucidis Instant Focus© - PMCF Study Protocol
Official title: Evaluation of Efficacy and Long-term Safety for Lucidis Instant Focus© - PMCF Study Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Lead sponsor: SAV-IOL SA
Sponsor class: INDUSTRY
Collaborators: name: CEISO
First posted: 2021-02-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with significant reduction in visual acuity and/or visual comfort from cataract requiring intra ocular lens implantation

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 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 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)

Primary outcomes:
measure: Visual acuity measure BCVA photopic
timeFrame: 1 year
measure: Visual acuity measure UCVA photopic
timeFrame: 1 year
measure: Visual acuity measure BCVA mesopic
timeFrame: 1 year
measure: Visual acuity measure UCVA mesopic
timeFrame: 1 year
Secondary outcomes:
measure: Contrast sensitivity measure photopic
timeFrame: 1 year
measure: Contrast sensitivity measure mesopic
timeFrame: 1 year
measure: Safety assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Hôpital Jules Gonin
Study officials:
affiliation: Institut jules gonin
name: Kate Hashemi, Pr
role: PRINCIPAL_INVESTIGATOR
References: