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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Implantation of monofocal IOL Micropure 1.2.3
Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico
Rome, Italy
Fondazione GB Bietti - IRCCS
Rome, Italy
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).
Time frame: 6 months postoperative
Posterior capsule opacification (PCO) grading
grade of the PCO determined by slitlamp
Time frame: 2 years postoperative
Uncorrected Distance Visual acuity (UDVA)
Monocular Uncorrected Distance Visual acuity (UDVA)
Time frame: 6 months postoperative
Contrast Sensitivity
Contrast Sensitivity under photopic and mesopic light conditions
Time frame: 6 months postoperative
Glistening assessment
Assessment of glistenings by slitlamp determination
Time frame: 2 years postoperative
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