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

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 Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Surgical implantation of intra ocular lens

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Kate Hashemi, Pr; Phone Number: +41 21 626 81 11; Email: kattayoon.hashemi@fa2.ch

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1004
    • Recruiting
    • Hôpital Jules Gonin
    • Contact: Kate Hashemi, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lucidis Intra-ocular lens (IOL); Adult patients with significant reduction in visual acuity and/or visual comfort from cataract who will receive Lucidis Intra-ocular lens	Device: Surgical implantation of intra ocular lens; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity measure BCVA photopic	Far Best Corrected Visual Acuity in photopic conditions	1 year
Visual acuity measure UCVA photopic	Near, intermediate and far Uncorrected visual acuity in photopic conditions	1 year
Visual acuity measure BCVA mesopic	Far Best Corrected Visual Acuity in mesopic conditions	1 year
Visual acuity measure UCVA mesopic	Near, intermediate and far Uncorrected visual acuity in mesopic conditions	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity measure photopic	Contrast sensitivity in photopic conditions	1 year
Contrast sensitivity measure mesopic	Contrast sensitivity in mesopic conditions	1 year
Safety assessment	Adverse reactions	1 year

Collaborators and Investigators

• Sponsor: SAV-IOL SA
• Collaborators: CEISO
• Investigators: Principal Investigator: Kate Hashemi, Pr, Institut jules gonin

Publications and helpful links

Helpful Links

• SAV IOL website

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: LUCIDIS2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No