Premium Trifocal IOL Comparative Analysis
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 optimization the computation constants of the lens power.
|Condition or Disease||Intervention/Treatment||Phase|
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 vision, the investigational lens will be mono- or bilaterally implanted.
Clinically retro- and prospective, non-randomized, uncontrolled, open study at several centers: University Eye Clinic Heidelberg (leading center), Practice Center Ahaus in the Eye Clinic Ahaus, Breyer, Kaymak & Klabe Eye Surgery in Düsseldorf, nordBLICK Eye Center Kiel.
Functional results (refraction and visual acuity results) Secondary goals:
Deviation target vs. achieved postoperative refraction (for constant optimization of the IOL calculation)
Subjective patient satisfaction
Visual quality (e.g. scattered light, contrast vision, spherical aberrations)
Stability of the results achieved postoperatively
Arms and Interventions
|Experimental: Experimental: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation
PhysIOL POD F GF: 50 (bilateral implantation) PhysIOL POD F: 50 (bilateral implantation) Alcon PanOptix: 20 (bilateral implantation) In this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated.
Device: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation
In this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated.
Primary Outcome Measures
- Monocular Best corrected distance visual acuity (5 m) [Postoperative Day 75-105 (3 months)]
CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014.
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
Age of patient <45 years
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)
Intraoperative complications like capsular rupture etc.
Patients who do not give informed consent
Contacts and Locations
|2||Internationale Innovative Ophthalmochirgie||Düsseldorf||Germany||40212|
Sponsors and Collaborators
- Beaver-Visitec International, Inc.
- Principal Investigator: Gerd Auffarth, MD, PhD, University Hospital Heidelberg
Study Documents (Full-Text)None provided.