An interventional study of Nitinol net for intracorneal implant for keratoconus treatment in Keratoconus, sponsored by Recornea Srl. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Recornea Srl · Not applicable, Interventional, and Treatment
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.
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 > 47.2 D and RMS of coma aberration > 2.5 μm, which are not recommended 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 aims to treat 12 patients separated by a safety period of at least 14 days between each one allowing safety monitoring. For each patient, the following treatment strategy will be applied:
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 12 is below the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →This is the only study on the registry with Recornea Srl as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will undergo the planned surgical intervention for the implantation of the investigational medical device and will be monitored for up to 1 year after the procedure.
Device: Nitinol net for intracorneal implant for keratoconus treatment
The 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.
Time frame: From enrolment up to 12 months post-procedure
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)
Time frame: From baseline up to 12 months post-procedure
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)
Time frame: From baseline up to 12 months post-procedure
Changes in IOP from baseline to 12 months
IOP is measured with tonometer
Time frame: From baseline up to 12 months post-procedure
Changes in corrected IOP (bIOP) from baseline to 12 months
bIOP is measured using a biomechanically based tonometry method
Time frame: From baseline up to 12 months post-procedure
Changes in macular central thickness from baseline to 12 months
Central macular thickness is assessed with a posterior Optical Coherence Tomography (OCT).
Time frame: From baseline up to 12 months post-procedure
Changes in Endothelial Cell Count (ECC) from baseline to 12 months
Corneal endothelium assessment is performed with specular microscope
Time frame: from baseline up to 12 months post-procedure
Subjective numeric scale related to several ocular symptoms
Subjective numeric scale ranked from 0 (no pain at all) to 10 (the maximum pain ever felt) related to pain, foreign body sensation, tearing, photophobia, glare and halos
Time frame: From baseline to 12 months post-procedure
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.
Time frame: From baseline up to 12 months post-procedure
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.
Time frame: From baseline up to 12 months post-procedure
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
Time frame: From baseline up to 12 months post-procedure
Changes in Manifest Refraction Spherical Equivalent (MRSE) from baseline to 12 months
MRSE is measured in dioptres, determined by refraction using ETDRS optotypes
Time frame: From baseline up to 12 months post-procedure
Changes in Symmetry Index (SI) from baseline to 12 months
SI index is measured in diopters with Topographer
Time frame: From baseline up to 12 months post-procedure
Changes in Center-Surrounding Index (CSI) from baseline to 12 months
CSI index is measured in diopters with Topographer
Time frame: From baseline up to 12 months post-procedure
Assessment of the topographic centration of the implant
Assessment of the coordinates of the centration of the device in the cornea (in dioptres and degrees).
Time frame: From surgery up to 12 months post-procedure
Changes in Uncorrected Visual Acuity (UNCVA) from baseline to 12 months
UNCVA is assessed using ETDRS
Time frame: From baseline up to 12 months post-procedure
Changes in Best Corrected Visual Acuity with rigid gas permeable contact lens (RGP-BCVA) from baseline to 12 months
RGP-BCVA is assessed in LogMAR units using ETDRS
Time frame: From baseline up to 12 months post-procedure
Changes in biomechanical corneal properties expressed as Corneal Hysteresis (CH) from baseline to 12 months
Corneal Hysteresis is measured in mmHg with the Ocular Response Analyzer (ORA)
Time frame: From baseline up to 12 months post-procedure
Changes in biomechanical corneal properties, expressed as Deformation Amplitude Ratio (DA Ratio) from baseline to 12 months
Deformation Amplitude Ratio (DA Ratio) is measured in mm/sd with Corvis ST
Time frame: From baseline up to 12 months post-procedure
Changes in biomechanical corneal properties, expressed as Integrated Radius from baseline to 12 months
Integrated Radius is measured in mm/sd with Corvis ST
Time frame: From baseline up to 12 months post-procedure
Changes in biomechanical corneal properties, expressed as ARTH from baseline to 12 months
ARTH is measured in μm/sd with Corvis ST
Time frame: From baseline up to 12 months post-procedure
Changes in biomechanical corneal properties, expressed as Stiffness Parameter at first Applanation (SP-A1) from baseline to 12 months
Stiffness Parameter at first Applanation (SP-A1) is measured in pr/mm/sd with Corvis ST
Time frame: From baseline up to 12 months post-procedure
Changes in biomechanical corneal properties, expressed as Stress-Strain Index (SSI) from baseline to 12 months
Stress-Strain Index (SSI) is calculated with Corvis ST
Time frame: From baseline up to 12 months post-procedure
Changes in Vision Related Quality of Life (VRQoL) from baseline to 12 months
The NEI-42 questionnaire provides a final score reflecting vision-related quality of life. All items are scored so that higher values indicate better quality of life. Each response is converted to a 0-100 scale, where 0 represents the lowest and 100 the highest possible score. The domains evaluated include: clarity of vision, expectations, near vision, distance vision, diurnal fluctuations, activity limitations, glare, symptoms, dependence on correction, worry, suboptimal correction, appearance, and satisfaction with correction.
Time frame: At screening visit (preoperatively) and at study end (12 months post-procedure)
Stability of the corneal applanation between 6 and 12 months
Corneal curvature or applanation is measured in dioptres, measured with a topographer
Time frame: Between 6 and 12 months post-procedure
Changes in optical quality expressed as RMS from baseline to 12 months
RMS value is measured in μm with the MS-39 topographer
Time frame: From baseline up to 12 months post-procedure
Changes in optical quality expressed as OSI value from baseline to 12 months
OSI value is measured with the HD Analizer, if available
Time frame: From baseline up to 12 months post-procedure
Plan to share: Yes — De-identified individual participant data that underlie the results reported in this study will be made available upon reasonable request from qualified researchers, subject to the sponsor's discretion, in order to protect participant privacy and sponsor confidentiality.
Supporting information: Clinical study report
Started Sep 2024 (actual). Primary completion is estimated for Feb 2027, 29 months after the start.
Of 68 interventional studies with no phase under Keratoconus, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 29 months is below that.
How these figures are worked out, and which studies are left out of them.
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