Premium Trifocal IOL Comparative Analysis

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.

Main objectives:

• 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

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