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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-21

Study Completion Date

2022-10-31

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.

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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.

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Surgical implantation of intra ocular lens

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No