Premium Trifocal IOL Comparative Analysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Development of a Database (Register) for Quality Assurance and Optimization of the Postoperative Results of Premium Intraocular Lenses

Conditions
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Cataract, Lens Opacities, Presbyopia

Intervention / Treatment
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* Device: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Study procedure guidelines Patients who were previously treated with a premium IOL (Panoptix, POD FGF, POD F) are continuously included: Retrospective: Routine data collected up to the first study visit (preoperative, intraoperative and postoperative) are evaluated retrospectively Prospective: 2-4 months postoperatively: refraction and vision, slit lamp and fundus examination, intraocular
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Best corrected distance visual acuity (5 m) | CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014. | Postoperative Day 75-105 (3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular lens, Trifocal