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

NCT04761276 | Unknown

• 1 other identifier: LUCIDIS2021
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Contrast sensitivity measure photopic

  1 year

• Contrast sensitivity measure mesopic

  1 year

• Safety assessment

  1 year

Study Arms (1)

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

Interventions

Surgical implantation of intra ocular lens DEVICE

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.

Lucidis Intra-ocular lens (IOL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• SAV-IOL SA: lead
• CEISO: collaborator

Study Sites (1)

Hôpital Jules Gonin

Lausanne, 1004, Switzerland

RECRUITING

Related Links

• SAV IOL website

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Kate Hashemi, Pr

  Institut jules gonin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Hashemi, Pr

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 18, 2021
• Study Start: May 21, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)