Clinical trial NCT06451718: First in Human Study to Assess the Safety and the Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Keratoconus
Lead sponsor: Fundacio De Recerca Del Instituto De Microcirugia Ocular
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants with keratoconus
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Male and female ≥ 18 years old
* Not suitable for ICRS and are recommended for keratoplasty
* Best distance spectacle corrected visual acuity (BDCSVA) 1.30 - 0.40 logMAR (0.05-0,40 decimal notation)
* Have stable or stabilized disease for 12 months (in case of cross-linking, it must have been done 12 months prior to intervention)
* Have a KC stage 3-4 (Amsler-Krumeich) with a Central K readings \> 53.00 D and RMS of coma aberration \> 3.5.
* Signed and dated informed consent form

Exclusion Criteria:

* 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
* Minimum Corneal thickness \< 400 μm
* Other ocular diseases (eyelids malposition, uveitis, ocular hypertension, glaucoma, cataract, retinal disorders) or corneal surgeries (refractive corneal surgery, keratoplasty), except corneal crosslinking
* Systemic collagenopathies and/or vasculitis, and other diseases that in the opinion of the principal investigator may be contraindicated

Primary outcomes:
measure: Incidence of Treatment-Emergent adverse events , classification and related severity
timeFrame: 6 months follow up
measure: Slit lamp corneal assessment. Observations will be graded as follows:0- Absence 1- Mild 2- Moderate 3- Severe
timeFrame: 6 months follow up
measure: Epithelial corneal thickness assessments
timeFrame: 6 months follow up
measure: Intraocular pressure (IOP) assessments
timeFrame: 6 months follow up
measure: Corrected IOP (bIOP) assessments
timeFrame: 6 months follow up
measure: Macular central thickness assessments
timeFrame: 6 months follow up
measure: Corneal endothelium assessments
timeFrame: 6 months follow up
measure: Best Distance Spectacle Corrected Visual Acuity (BDSCVA)
timeFrame: 6 month follow up
measure: Subjective numeric scale related to several ocular symptoms, graded from 0 to 10. lower scores reflect better symptomatology outcome
timeFrame: 6 month follow up
Secondary outcomes:
measure: Measurement of topographic keratometry values
timeFrame: 6 month follow up
measure: Measurement of topographic astigmatism
timeFrame: 6 month follow up
measure: Measurement of refractive astigmatism
timeFrame: 6 month follow up
measure: Measurement of manifest refraction sphere equivalent (MRSE)
timeFrame: 6 month follow up
measure: Measurement of irregularity index (IR)
timeFrame: 6 month follow up
measure: Assessment of the centration of the intracorneal implant
timeFrame: 6 month follow up
measure: Measurement of Uncorrected Visual Acuity (UCVA)
timeFrame: 6 month follow up
measure: Best Corrected Visual Acuity(BCVA) with rigid gas permeable(RGP) contact lens (RGP-BCVA)
timeFrame: 6 month follow up
measure: Measurement of Optical surface index (OSI) related to Optical Quality
timeFrame: 6 month follow up
measure: Measurement of Root Mean Square (RMS) related to Optical Quality
timeFrame: 6 month follow up
measure: Measurement of biomechanical properties and characterization of the cornea by measuring Deflection Amplitude Ratio (DAR: Deflection Amplitude Ratio)
timeFrame: 6 month follow up
measure: Measurement of biomechanical properties and characterization of the cornea by measuring ,Integrated Radius
timeFrame: 6 month follow up
measure: Measurement of biomechanical properties and characterization of the cornea by measuring, Ambrósio Relational Thickness horizontal (ARTh)
timeFrame: 6 month follow up
measure: Measurement of biomechanical properties and characterization of the cornea by measuring Stiffness Parameter-A1 (SP-A1) and Stress-Strain Index (SSI)
timeFrame: 6 month follow up
measure: Measurement of biomechanical properties and characterization of the cornea by measuring Stress-Strain Index (SSI)
timeFrame: 6 month follow up
measure: Measurement of vision Related Quality of Life (VRQoL)
timeFrame: 6 month follow up
measure: Assessment of the corneal applanation
timeFrame: 6 month follow up
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Instituto de Microcirugía Ocular de Barcelona (IMO)
state: Bar
Study officials:
References: