Cataract
Conditions
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.
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.
Interventions
DEVICESurgical 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.
Sponsors
CEISO
SAV-IOL SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity measure BCVA photopic | 1 year | Far Best Corrected Visual Acuity in photopic conditions |
| Visual acuity measure UCVA photopic | 1 year | Near, intermediate and far Uncorrected visual acuity in photopic conditions |
| Visual acuity measure BCVA mesopic | 1 year | Far Best Corrected Visual Acuity in mesopic conditions |
| Visual acuity measure UCVA mesopic | 1 year | Near, intermediate and far Uncorrected visual acuity in mesopic conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast sensitivity measure mesopic | 1 year | Contrast sensitivity in mesopic conditions |
| Safety assessment | 1 year | Adverse reactions |
| Contrast sensitivity measure photopic | 1 year | Contrast sensitivity in photopic conditions |
Countries
Switzerland
Contacts
Primary ContactKate Hashemi, Pr
Outcome results
None listed