Premium Trifocal IOL Comparative Analysis

Cataract Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Cataract
• Lens Opacities
• Presbyopia

• NCT number: NCT04875455
• Study type: Interventional
• Source: Beaver-Visitec International, Inc.
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Completion date: November 17, 2021