Cataract, Lens Opacities
Conditions
Keywords
Intraocular lens, monofocal, cataract, PhysIOL
Brief summary
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
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.
Interventions
DEVICEIOL implantation
Implantation of monofocal IOL Micropure 1.2.3
Sponsors
Beaver-Visitec International, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions | 6 months postoperative | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glistening assessment | 2 years postoperative | Assessment of glistenings by slitlamp determination |
| Posterior capsule opacification (PCO) grading | 2 years postoperative | grade of the PCO determined by slitlamp |
| Uncorrected Distance Visual acuity (UDVA) | 6 months postoperative | Monocular Uncorrected Distance Visual acuity (UDVA) |
| Contrast Sensitivity | 6 months postoperative | Contrast Sensitivity under photopic and mesopic light conditions |
Countries
Italy
Outcome results
None listed