Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327347
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-18
Brief Title:
Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg
Sponsor:
Cristalens Industrie
Organization:
Cristalens Industrie
Study Overview
Official Title:
Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C2H
Brief 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
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 11 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 141552020 Clinical Investigation of Medical Devices for Human Subjects EN ISO 11979-72018 Clinical investigations of intraocular lenses for the correction of aphakia EU MDR 2017745 MEDDEV 271 rev 4 Clinical Evaluation A Guide for Manufacturers and Notified Bodies MPDG2020 Medical Device Law Implementation Act as well as applicable local regulations and the Declaration of Helsinki
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 141552020 Clinical Investigation of Medical Devices for Human Subjects EN ISO 11979-72018 Clinical investigations of intraocular lenses for the correction of aphakia EU MDR 2017745 MEDDEV 271 rev 4 Clinical Evaluation A Guide for Manufacturers and Notified Bodies MPDG2020 Medical Device Law Implementation Act as well as applicable local regulations and the Declaration of Helsinki
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None