Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-01-04 @ 4:19 PM
Study NCT ID:
NCT06451718
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First in Human Study to Assess the Safety and the Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus
Sponsor:
Fundacio De Recerca Del Instituto De Microcirugia Ocular
Organization:
Study Overview
Official Title:
First in Human Study to Assess the Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Stage 3 and 4 Keratoconus (KC)
Status:
RECRUITING
Status Verified Date:
2024-06
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:
This Study is a first in human clinical study addressed to evaluate the safety and efficacy of a novel intra-corneal nitinol device (Investigational Device; GROSSO® implant) for the treatment of advanced keratoconus disease of the eye.
Detailed Description:
The medical device under investigation is a sterile thin 8-mm diameter circular scaffold made of a nickel-titanium alloy (nitinol) that is intended as a permanent implant that is surgically inserted into the cornea in order to modify force by inducing a change in corneal shape and consequently improving vision. This Study is aimed at adults with a stage 3-4 keratoconus, a central K reading \> 53.00 D and RMS of coma aberration \> 3.5, which are not eligible for Intrastromal Corneal Ring Segments (ICRS) and are recommended for keratoplasty.
Therefore, this study represents a salvage route to preserve the cornea. Envisaged worst case scenario of failure of the experimental device patients would be redirected to keratoplasty.
Therefore, this study represents a salvage route to preserve the cornea. Envisaged worst case scenario of failure of the experimental device patients would be redirected to keratoplasty.
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?: