Premium Trifocal IOL Comparative Analysis

Not Applicable

Completed

• Conditions: Cataract; Presbyopia; Lens Opacities
• Interventions: Device: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation

• Registration Number: NCT04875455
• Lead Sponsor: Beaver-Visitec International, Inc.

Brief 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

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2021-05-01
• Study First Submitted QC: 2021-05-01
• Study First Posted: 2021-05-06
• Primary Completion: 2021-11-17
• Study Completion: 2021-11-17
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Internationale Innovative Ophthalmochirgie; 🇩🇪 Düsseldorf, Germany

Augenklinik Ahaus; 🇩🇪 Ahaus, Germany

Augentagesklinik Rheine; 🇩🇪 Rheine, Germany

Universitäts-Augenklinik Heidelberg; 🇩🇪 Heidelberg, Germany