Viewing Study NCT04465344



Ignite Creation Date: 2024-05-06 @ 2:55 PM
Last Modification Date: 2024-10-26 @ 1:39 PM
Study NCT ID: NCT04465344
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-09-14
First Post: 2020-07-07

Brief Title: Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens
Sponsor: Cutting Edge SAS
Organization: Cutting Edge SAS

Study Overview

Official Title: Multicentric Clinical Study to Determine Safety and Efficacy of a Hydrophobic Acrylic Trifocal Intraocular Lens IOL
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-09
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: None
Brief Summary: The study will be a multicentric prospective open-label ethics committee approved clinical study to investigate safety visual outcomes contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery
Detailed Description: This is a staged multicentric controlled prospective open-label clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic acrylic refractive trifocal intraocular lenses Isatis TF or the monofocal control device Isatis

The investigational device Control lens and all study products including the devices used for the study examinations will be used within the intended use specifications from the manufacturer In addition no invasive or other burdening examinations will occur for the patient

The study will be carried out in up to five clinical centers in Spain

The device under investigation is a hydrophobic acrylic trifocal intraocular lens IOL manufactured by the sponsor of this study The trifocality of this investigational device is based on a purely refractive principle with the goal to provide additional near and intermediate visual acuity with low photic side effects The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development

The control device Isatis is a hydrophobic acrylic monofocal intraocular lens to be implanted during cataract surgery This control lens is CE approved and commercially available in Spain Isatis monofocal lens is the parent lens of the device under investigation and both lenses share mechanical and material properties

In total 180 patients will be recruited for this clinical study and undergo bilateral implantation of the Isatis TF intraocular lens or Isatis lens in a 21 ratio Subjects participating in the trial will attend a total of maximum 11 study visits over a period of 11-13 months Subjects would have the option for unscheduled visits if required medically

Data analyses will be performed after the last patient finished the 120-180 days postoperative examination

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