Status:
COMPLETED
Clinical Study to Compare Visual Performance of Two Trifocal IOLs
Lead Sponsor:
Beaver-Visitec International, Inc.
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material
Detailed Description
This is a prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation ...
Eligibility Criteria
Inclusion
- Cataractous eyes with no comorbidity
- Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent
Exclusion
- Irregular astigmatism
- Age of patient \< 50 years
- Regular corneal astigmatism \>1.00 dioptres by an automatic keratometer or biometer or \>1.25 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes
- 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)
- AMD suspicious eyes (determined by OCT)
- Complicated surgery
Key Trial Info
Start Date :
October 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2019
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03347981
Start Date
October 2 2017
End Date
May 21 2019
Last Update
May 6 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Innova Ocular IOA Madrid
Madrid, Spain, 28003