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First in Human Study to Assess the Safety and the Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

Keratoconus Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06451718
Study type Interventional
Source Fundacio De Recerca Del Instituto De Microcirugia Ocular
Contact
Status Recruiting
Phase N/A
Start date May 7, 2024
Completion date December 2025
View Details
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