Status:
COMPLETED
Premium Trifocal IOL Comparative Analysis
Lead Sponsor:
Beaver-Visitec International, Inc.
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Short and long-term analysis of the refraction correction and optical image quality of modern premium intraocular lenses (IOLs) with the establishment of a database for quality assurance and optimizat...
Detailed Description
Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vis...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Bilateral implantation of one of the following IOL models
- Alcon PanOptix (TFNT00)
- PhysIOL FineVision (POD F)
- PhysIOL FineVision (POD F GF)
- Uneventful cataract surgery with first clinical outcomes in the expected range
- Patient included in Premium IOL study protocol by signed informed consent
- Exclusion criteria
- Age of patient \<45 years
- Irregular astigmatism
- Postoperative manifested astigmatism of \>1.0 D
- Difficulty for cooperation (distance from their home, general health condition)
- Clinically significant glaucoma
- Clinically significant macular degeneration, clinically significant macular edema or proliferative diabetic retinopathy
- Patients with keratoconus or keratectasia
- Any ocular comorbidity having a significant effect on the postoperative clinical outcomes
- 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 abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
- AMD
- Intraoperative complications like capsular rupture etc.
- Patients who do not give informed consent
Exclusion
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2021
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04875455
Start Date
November 1 2017
End Date
November 17 2021
Last Update
January 11 2022
Active Locations (4)
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1
Augenklinik Ahaus
Ahaus, Germany, 48683
2
Internationale Innovative Ophthalmochirgie
Düsseldorf, Germany, 40212
3
Universitäts-Augenklinik Heidelberg
Heidelberg, Germany, 69120
4
Augentagesklinik Rheine
Rheine, Germany, 48429