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

Swiss Advanced Vision - Intraocular Lens (SAV-IOL)

Status: Unknown

Conditions: Cataract

Treatments: Device: Surgical implantation of intra ocular lens

Study type: Observational

Funder types: Industry

Identifiers

NCT04761276

LUCIDIS2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

120 participants in 1 patient group

Lucidis Intra-ocular lens (IOL)

Description:

Adult patients with significant reduction in visual acuity and/or visual comfort from cataract who will receive Lucidis Intra-ocular lens

Treatment:

Device: Surgical implantation of intra ocular lens