Clinical Study to Investigate Visual Performance of Hydrophobic Monofocal IOL: MicroPure 1.2.3.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Beaver-Visitec International, Inc.
- Enrollment
- 121
- Locations
- 2
- Primary Endpoint
- monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions
Time Frame: 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 Outcomes
- Posterior capsule opacification (PCO) grading(2 years postoperative)
- Contrast Sensitivity(6 months postoperative)
- Glistening assessment(2 years postoperative)
- Uncorrected Distance Visual acuity (UDVA)(6 months postoperative)