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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04761276
• Other study ID #: LUCIDIS2021
• Status: Recruiting
• Start date: May 21, 2021
• Est. completion date: October 2022

Study information

• Verified date: May 2021
• Source: SAV-IOL SA
• Contact: Kate Hashemi, Pr
• Phone: +41 21 626 81 11
• Email: kattayoon.hashemi[@]fa2.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cataract

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Hôpital Jules Gonin	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
SAV-IOL SA	CEISO

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity measure BCVA photopic	Far Best Corrected Visual Acuity in photopic conditions	1 year
Primary	Visual acuity measure UCVA photopic	Near, intermediate and far Uncorrected visual acuity in photopic conditions	1 year
Primary	Visual acuity measure BCVA mesopic	Far Best Corrected Visual Acuity in mesopic conditions	1 year
Primary	Visual acuity measure UCVA mesopic	Near, intermediate and far Uncorrected visual acuity in mesopic conditions	1 year
Secondary	Contrast sensitivity measure photopic	Contrast sensitivity in photopic conditions	1 year
Secondary	Contrast sensitivity measure mesopic	Contrast sensitivity in mesopic conditions	1 year
Secondary	Safety assessment	Adverse reactions	1 year

External Links

•   SAV IOL website