Status:
COMPLETED
Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.
Lead Sponsor:
Beaver-Visitec International, Inc.
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
45+ years
Phase:
NA
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 mo...
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.
Eligibility Criteria
Inclusion
- Cataractous eyes with no comorbidity
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2022
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03297372
Start Date
October 23 2017
End Date
September 8 2022
Last Update
October 28 2022
Active Locations (2)
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1
Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico
Rome, Italy, 00184
2
Fondazione GB Bietti - IRCCS
Rome, Italy, 00198