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

• Conditions: Cataract

• Registration Number: NCT04761276
• Lead Sponsor: SAV-IOL SA

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.

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-18
• Status Verified: 2021-05
• Study Start: 2021-05-21
• Last Update Submitted: 2021-05-25
• Last Update Posted: 2021-05-27
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity measure BCVA photopic	1 year	Far Best Corrected Visual Acuity in photopic conditions
Visual acuity measure UCVA mesopic	1 year	Near, intermediate and far Uncorrected visual acuity in mesopic conditions
Visual acuity measure BCVA mesopic	1 year	Far Best Corrected Visual Acuity in mesopic conditions
Visual acuity measure UCVA photopic	1 year	Near, intermediate and far Uncorrected visual acuity in photopic conditions

Secondary Outcome Measures

Name	Time	Method
Safety assessment	1 year	Adverse reactions
Contrast sensitivity measure mesopic	1 year	Contrast sensitivity in mesopic conditions
Contrast sensitivity measure photopic	1 year	Contrast sensitivity in photopic conditions

Trial Locations

Locations (1)

Hôpital Jules Gonin; 🇨🇭 Lausanne, Switzerland