NCT04875455

Premium Trifocal IOL Comparative Analysis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Beaver-Visitec International, Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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 optimization the computation constants of the lens power.

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 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: 1. Functional results (refraction and visual acuity results) Secondary goals: 2. Deviation target vs. achieved postoperative refraction (for constant optimization of the IOL calculation) 3. Subjective patient satisfaction 4. Visual quality (e.g. scattered light, contrast vision, spherical aberrations) 5. Stability of the results achieved postoperatively

Conditions

• Cataract
• Lens Opacities
• Presbyopia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-01
• Primary completion: 2021-11-17
• Completion: 2021-11-17
• First posted: 2021-05-06
• Last updated: 2022-01-11

Locations

4 sites across 1 country: Germany