Prospective Evaluation of an Hydrophilic Acrylic Intraocular Lens

Study Overview
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Brief Summary
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Evaluation of the clinical safety and effectiveness of an hydrophilic acrylic intraocular lens

Detailed Description
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To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) and the distance-corrected near visual acuity (DCNVA) at 6 months postoperative.

Official Title
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Prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens

Conditions
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Cataract Senile

Intervention / Treatment
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* Device: Intraocular lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of any gender, aged 18 years or older Patient is planned for aged-related cataract surgery and implantation of the study IOL into the capsular bag in at least one eye Patient is willing and capable of providing informed consent Patient is willing and capable of complying with visits and procedures as defined by this protocol Exclusion Criteria: Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal) Endothelial cell count of less than 2000/mm2 Ocular disorder that could potentially cause a clinically significant future visual acuity loss Preoperative corneal astigmatism ative corneal to be < 1 D. Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.) Clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies) Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.) Any History of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis Any acute infection (acute ocular disease, external/internal infection, systemic infection) Any previous intraocular and corneal surgery Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment Current systemic or ocular pharmacotherapy that effects patients'vision Current pathology or condition that could be a risk for the patient according to the investigator opinion Women during pregnancy and/or lactation Patients unable to meet the limitations of the protocol or likely of noncooperation during the trial Patients whose freedom is impaired by administrative or legal order Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients'vision

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifocal IOL<br>Implantation of a multifocal intraocular lens | Device: Intraocular lens<br>* Cataract surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular corrected distance visual acuity (CDVA) | Monocular corrected distance visual acuity measured in logMAR | 6 months after the implantation |