This Study is a First In Human clinical investigation addressed to evaluate the safety and efficacy of a novel intra-corneal nitinol device (Investigational Medical Device: GROSSO® implant) for the treatment of advanced keratoconus disease of the eye.
Signed and dated informed consent form.
Male and female ≥ 18 years old.
Not recommended for ICRS.
Recommended for keratoplasty.
Inability of patient and/or relatives to understand the clinical investigation procedures and thus inability to give informed consent.
Untreated progressive KC.
Single functioning eye.
Other ocular diseases (eyelids malposition, uveitis, ocular hypertension, glaucoma, cataract, retinal disorders) or corneal surgeries (refractive corneal surgery, keratoplasty), except corneal crosslinking.
Single group
Nitinol net for intracorneal implant for keratoconus treatment
DeviceThe investigational corneal implant device is designed for patients with keratoconus. It is intended to be surgically implanted into the cornea as a permanent implant and is made of nitinol. The device is intended to improve corneal stability and visual outcomes.
Incidence of Serious Adverse Device Effects (SADE), Adverse Events (AE), and Serious Adverse Events (SAE)
Number and type of adverse events, serious adverse events, and serious adverse device effects observed during follow-up.
Changes in corneal alterations from baseline to 12 months.
Slit Lamp corneal assessments to evaluate: * Corneal inflammation * Corneal infection * Corneal stromal lysis * Corneal melting * Corneal stromal infiltration * Corneal neo vessels * Persistent corneal epithelial defects Observations will be graded from 0 (Absence) to 3 (Severe)
Changes in total and epithelial corneal thickness (central and minimum) from baseline to 12 months.
Measurement of total and epithelial corneal thickness (central and minimum)
Changes in IOP from baseline to 12 months
IOP is measured with tonometer
Changes in Best Distance Spectacle Corrected Visual Acuity (BDSCVA) from baseline to 12 months
BDSCVA is performed using ETDRS (Early Treatment Diabetic Retinopathy Study) refraction and vision testing protocol.
Changes in topographic keratometry values from baseline to 12 months
Corneal topography is performed by using the topographer. The values collected are Kmax, K steep, K flat and Km.
Changes in topographic and refractive astigmatism from baseline to 12 months
Topographic astigmatism is measured in dioptres with the Topographer. Refractive astigmatism is measured in dioptres and axis, determined by refraction using ETDRS optotypes
Changes in Manifest Refraction Spherical Equivalent (MRSE) from baseline to 12 months
MRSE is measured in dioptres, determined by refraction using ETDRS optotypes
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