Status:
COMPLETED
Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation
Lead Sponsor:
Beaver-Visitec International, Inc.
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.
Detailed Description
This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have bilateral...
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 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°
- 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
- Patients who do not give informed consent
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03423524
Start Date
May 2 2018
End Date
July 27 2021
Last Update
February 15 2022
Active Locations (1)
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1
Ophtalmology department - CHU liège
Liège, Belgium, 4000