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

SAV-IOL SA120 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Cataract

Interventions

Surgical implantation of intra ocular lensDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Hôpital Jules Gonin

Lausanne, Switzerland

RECRUITING

Outcomes

Primary Outcomes

Visual acuity measure BCVA photopic

Far Best Corrected Visual Acuity in photopic conditions

Time frame: 1 year

Visual acuity measure UCVA photopic

Near, intermediate and far Uncorrected visual acuity in photopic conditions

Time frame: 1 year

Visual acuity measure BCVA mesopic

Far Best Corrected Visual Acuity in mesopic conditions

Time frame: 1 year

Visual acuity measure UCVA mesopic

Near, intermediate and far Uncorrected visual acuity in mesopic conditions

Time frame: 1 year

Secondary Outcomes

Contrast sensitivity measure photopic

Contrast sensitivity in photopic conditions

Time frame: 1 year

Contrast sensitivity measure mesopic

Contrast sensitivity in mesopic conditions

Time frame: 1 year

Safety assessment

Adverse reactions

Time frame: 1 year

Central Contacts

Kate Hashemi, Pr

CONTACT

+41 21 626 81 11 kattayoon.hashemi@fa2.ch

Data from ClinicalTrials.gov

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