Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05139771
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2021-10-20
Brief Title:
EndoArt Implantation in Subjects With Chronic Corneal Edema
Sponsor:
Eye-yon Medical
Organization:
Eye-yon Medical
Study Overview
Official Title:
An Open-label Multicenter Phase 2 Clinical Safety Investigation of the EndoArt Implantation in Subjects With Chronic Corneal Edema
Status:
COMPLETED
Status Verified Date:
2023-02
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 EndoArt is intended to be used as an endothelial prosthesis in patients with chronic corneal edemaThe EndoArt Artificial Endothelial layer is a permanent implant constructed of a clear transparent foldable biologically compatible copolymer of hydroxyethyl methacrylate and methyl methacrylate The peripheral surface of the EndoArt has either one or more marks to ensure the correct orientation of the implant The device serves as a physical barrier blocking the influx of water from the AC of the eye into the cornea due to dysfunctional corneal endothelial layer Together with evaporation from the anterior surface of the cornea it maintains corneal hydration and clarity
The EndoArt device is CE marked approved approved for marketing by the European regulatory authority
The EndoArt device is CE marked approved approved for marketing by the European regulatory authority
Detailed Description:
This study is a prospective multicenter open-label phase 2 clinical investigation assessing safety of EndoArt implantation in subjects with chronic corneal edema Safety will be assessed by evaluating the rate of adverse events and adverse device effects throughout the study period Exploratory efficacy endpoints will be assessed by measuring the change in corneal thickness from baseline change in pain score from baseline and changes in visual acuity Time to and rate of post-surgical rebubbling to facilitate adhesion of the device will be explored
Subjects with chronic corneal edema that meet the inclusionexclusion criteria will be the study target population The study will encompass a total of up to 80 subjects who will complete the Protocol follow-up schedule For the Primary endpoint the frequency and severity of device related adverse events from patient entry through the 6-month follow-up period will be analyzed Adverse events will be assessed on a continuous basis and will continue to be collected for 12 months
This clinical investigation is conducted in up to 12 twelve clinical sites in Europe Germany France and Netherlands Mexico India and Israel Additional sites may be considered
This clinical investigation has been designed to provide continuous clinical evidence for the EndoArt as part of its clinical follow up program
Subjects with chronic corneal edema that meet the inclusionexclusion criteria will be the study target population The study will encompass a total of up to 80 subjects who will complete the Protocol follow-up schedule For the Primary endpoint the frequency and severity of device related adverse events from patient entry through the 6-month follow-up period will be analyzed Adverse events will be assessed on a continuous basis and will continue to be collected for 12 months
This clinical investigation is conducted in up to 12 twelve clinical sites in Europe Germany France and Netherlands Mexico India and Israel Additional sites may be considered
This clinical investigation has been designed to provide continuous clinical evidence for the EndoArt as part of its clinical follow up program
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