NCT06327347

Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Cristalens Industrie · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the performance of 2 intraocular lenses (IOLs): ARTIS SYMBIOSE (study lenses) vs PANOPTIX (comparator) through binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative by a blinded evaluator. This main objective will be to show superiority of the ARTIS SYMBIOSE system on the primary endpoint. The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent. Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits.

Detailed description

This trial is a single center, prospective, randomized (1:1), unblinded, controlled study conducted in Germany according to Art. 82 MDR (PMCF study). The lead investigator at the Heidelberg Eye University Hospital - International Vision Correction Research Centre (IVCRC) is Pr. Gerd Auffarth. This study examines the visual performance of the two IOLs involved : Artis Symbiose (study lenses) compared to PanOptix (comparator) in bilaterally implanted patients. The aim of this comparative study is to assess the performance and safety of these two IOLs with targeting to demonstrate the superiority of Artis Symbiose in some specific performance parameters. The tested hypothesis is the superiority of Artis Symbiose over PanOptix IOLs on the primary evaluation criterion. A total of 50 patients will be included at one investigational center. Subjects participating in the study will attend a maximum of 5 study visits (1 preoperative, 1 operative and 3 postoperative visits) over a period of 12 months. Only patients who have age-related cataracts will be included in the study. To participate in this study, patients must be at least 50 years old at the time of screening and maximum 85 years old. All patients who would like to take part in this study will receive a detailed study information by the investigator staff and a written informed form. Before a patient is admitted, he or she must sign a consent form. The primary study endpoint is to compare the performance of 2 IOLs (Artis Symbiose, and PanOptix) through Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative by a blinded evaluator. The entire study including data processing will be carried out in accordance with EN ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects, EN ISO 11979-7:2018: Clinical investigations of intraocular lenses for the correction of aphakia, EU MDR 2017/745, MEDDEV 2.7.1 rev. 4 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, MPDG:2020: Medical Device Law Implementation Act, as well as applicable local regulations and the Declaration of Helsinki.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	intraocular lens implantation in cataract surgery	Implantation of intra ocular lenses in both patient's eyes in remplacement of the natural cataracted cristallin that has been removed from the patient's eye during the cataract surgery

Timeline

• Start date: 2022-07-17
• Primary completion: 2026-03-31
• Completion: 2026-07-31
• First posted: 2024-03-25
• Last updated: 2024-03-25

Locations

1 site across 1 country: Germany