Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

Study Overview
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Brief Summary
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The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).

Detailed Description
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The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp examinations and posterior capsule opacification (PCO) grading. Follow up will be up to 24 months postoperative.

Official Title
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Clinical Study to Investigate Visual Performance of Hydrophobic Monofocal IOL: MicroPure 1.2.3.

Conditions
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Cataract, Lens Opacities

Intervention / Treatment
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* Device: IOL implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cataractous eyes with no comorbidity Availability, willingness and sufficient cognitive awareness to comply with examination procedures Signed informed consent Exclusion Criteria: Irregular astigmatism Age of patient < 45 years Regular corneal astigmatism > 0.75 D on study eye as measured by an automatic keratometer (regularity determined by the topography of the keratometry) Difficulty for cooperation (distance from their home, general health condition) Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…) Any ocular comorbidity History of ocular trauma or prior ocular surgery including refractive procedures Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome) Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) Complicated surgery

Ages Eligible for Study
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Minimum Age: 45 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: IOL Implantation experimental<br>Implantation of Micropure 1.2.3. in one of the eyes of the study subject | Device: IOL implantation<br>* Implantation of monofocal IOL Micropure 1.2.3<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) under photopic conditions | The primary study end point is to show statistically equal visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions compared to literature data on a monofocal hydrophobic IOL (Alcon - Acrysof SN60AT). | 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posterior capsule opacification (PCO) grading | grade of the PCO determined by slitlamp | 2 years postoperative | 
| Uncorrected Distance Visual acuity (UDVA) | Monocular Uncorrected Distance Visual acuity (UDVA) | 6 months postoperative | 
| Contrast Sensitivity | Contrast Sensitivity under photopic and mesopic light conditions | 6 months postoperative | 
| Glistening assessment | Assessment of glistenings by slitlamp determination | 2 years postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular lens, monofocal, cataract, PhysIOL