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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: Surgical implantation of intra ocular lens


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lucidis Intra-ocular lens (IOL)<br>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<br>* 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.<br>|

What is the study measuring?
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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 |