KeratoconusNCT06451718
First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus
A study testing Nitinol net for intracorneal implant for keratoconus treatment in people with Keratoconus, run by Recornea Srl at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Nitinol net for intracorneal implant for keratoconus treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Sep 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form.
- Male and female ≥ 18 years old.
- Not recommended for ICRS.
- Recommended for keratoplasty.
- Minimum corneal thickness ≥ 350 μm.
- Best Distance Spectacle Corrected Visual Acuity (BDSCVA) with the ETDRS test ≥ 0.30 logMAR (<= 0,50 decimal notation).
Show all 11Show fewer
- BCVA with RGP contact lens with the ETDRS test 10 letters or more than BCVA with spectacles.
- Have stable or stabilized disease for 12 months (in case of crosslinking, it must have been done at least 12 months prior to intervention).
- Have a KC stage 3-4 according to Investigator's judgement, with a central K readings > 47.2 D and RMS of coma aberration > 2.5 μm.
- Have no known or suspected allergy to nickel.
- Female subject of childbearing potential is eligible to participate if declaring she is not pregnant, or not breastfeeding and agree to use highly effective contraception (defined as method which results in a failure rate of <1% annually) and must abstain from egg donation or storage throughout the study period.
Who cannot join
- 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.
- Systemic collagenopathies and/or vasculitis, and other diseases that in the opinion of the principal Investigator, may be contraindicated.
- Suspected or known intolerance or hypersensitivity to any of the treatments indicated in the CIP and/or to any component of the device (i.e. nickel).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Rossella Baldini, PhD contact
2 sites in 2 countries
Italy1 site, 1 recruiting
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Roma, 00168
Luigi Mosca, MD, +39 3386244046, luigi.mosca@policlinicogemelli.it
Romina Fasciani, MD
Spain1 site, 1 recruiting
- Recruiting
Instituto de Microcirugía Ocular de Barcelona (IMO)
Barcelona, Bar, 08035
Sandra Suescun, 0034934000700, sandra.suescun@imo.es
Tamara García, HNC, +934000700, tamara.garcia@miranza.es
About this study
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
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.
Read the 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 > 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:
- Unilateral KC: the affected eye meeting the eligibility criteria will be treated.
- Bilateral KC, one eye meeting the eligibility criteria: the eligible eye will be treated.
- Bilateral KC, both eyes meeting the eligibility criteria: the most severely compromised eye will be treated. Primary study objective is safety by identification or any local or systemic adverse events. Secondary objective will aim to evaluate efficacy that means a consequently improving of vision. Patients will be monitored at 1, 7, 21, 60, 180 and 365 days post implant surgery. Upon observance or any serious adverse event, increase in ocular pressure, device migration or discomfort, medical criteria or patient request, the patient will be offered for the device removed. The study will be early terminated if 3 patients have the experimental device removed for any reason or 4 patients withdraw from study.
- Conditions
- Keratoconus
- Being tested
- Nitinol net for intracorneal implant for keratoconus treatment
- Keywords
- GROSSO, Implant, Cornea, Surgery, Reshaper, keratoconus, keratoplasty, nitinol, corneal shape, remodeling
- Medical subject headings
- Keratoconus, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitinol net for intracorneal implant for keratoconus treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Device: Nitinol net for intracorneal implant for keratoconus treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: From baseline up to 12 months post-procedure
Changes in IOP from baseline to 12 months
IOP is measured with tonometer
Measured: 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
Measured: 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).
Measured: 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
Measured: 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
Measured: From baseline to 12 months post-procedure
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: From surgery up to 12 months post-procedure
Changes in Uncorrected Visual Acuity (UNCVA) from baseline to 12 months
UNCVA is assessed using ETDRS
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline up to 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start3 Sep 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled subjects with keratoconus will receive the surgical intervention and will be followed for up to 1 year post-procedure
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recornea Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edoardo Grosso, MD, Study director, Chief Medical Officer (CMO)José L. Güell, MD, Principal investigator, Head of the Cornea, Cataract and Refractive Surgery Department at IMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451718
- Sponsor's protocol ID
- REMKERA
- Status last verified
- Jan 2026
- First submitted
- 7 May 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06451718
- Acronym / sponsor ID
- REMKERA
- Conditions
- Keratoconus
- Keywords
- GROSSO, Implant, Cornea, Surgery, Reshaper, keratoconus, keratoplasty, nitinol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Recornea SrlIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 > 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:
- Unilateral KC: the affected eye meeting the eligibility criteria will be treated.
- Bilateral KC, one eye meeting the eligibility criteria: the eligible eye will be treated.
- Bilateral KC, both eyes meeting the eligibility criteria: the most severely compromised eye will be treated. Primary study objective is safety by identification or any local or systemic adverse events. Secondary objective will aim to evaluate efficacy that means a consequently improving of vision. Patients will be monitored at 1, 7, 21, 60, 180 and 365 days post implant surgery. Upon observance or any serious adverse event, increase in ocular pressure, device migration or discomfort, medical criteria or patient request, the patient will be offered for the device removed. The study will be early terminated if 3 patients have the experimental device removed for any reason or 4 patients withdraw from study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled subjects with keratoconus will receive the surgical intervention and will be followed for up to 1 year post-procedure
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Nitinol net for intracorneal implant for keratoconus treatmentAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed and dated informed consent form.
- Male and female ≥ 18 years old.
- Not recommended for ICRS.
- Recommended for keratoplasty.
- Minimum corneal thickness ≥ 350 μm.
Key exclusion criteria (6 listed)
- 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.
- Systemic collagenopathies and/or vasculitis, and other diseases that in the opinion of the principal Investigator, may be contraindicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitinol net for intracorneal implant for keratoconus treatmentThe 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. | Device | Study group |
Primary outcome
Incidence of Serious Adverse Device Effects (SADE), Adverse Events (AE), and Serious Adverse Events (SAE)
Time frame: From enrolment up to 12 months post-procedure
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.
Time frame: From baseline up to 12 months post-procedure
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.
Time frame: From baseline up to 12 months post-procedure
Measurement of total and epithelial corneal thickness (central and minimum)
Changes in IOP from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
IOP is measured with tonometer
Changes in corrected IOP (bIOP) from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
bIOP is measured using a biomechanically based tonometry method
Changes in macular central thickness from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
Central macular thickness is assessed with a posterior Optical Coherence Tomography (OCT).
Changes in Endothelial Cell Count (ECC) from baseline to 12 months
Time frame: from baseline up to 12 months post-procedure
Corneal endothelium assessment is performed with specular microscope
Subjective numeric scale related to several ocular symptoms
Time frame: From baseline to 12 months post-procedure
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
19 secondary outcomes
Changes in Best Distance Spectacle Corrected Visual Acuity (BDSCVA) from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
Changes in topographic keratometry values from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
Changes in topographic and refractive astigmatism from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
Changes in Manifest Refraction Spherical Equivalent (MRSE) from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
Changes in Symmetry Index (SI) from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
Changes in Center-Surrounding Index (CSI) from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
Assessment of the topographic centration of the implant
Time frame: From surgery up to 12 months post-procedure
Changes in Uncorrected Visual Acuity (UNCVA) from baseline to 12 months
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
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
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
Time frame: From baseline up to 12 months post-procedure
Changes in biomechanical corneal properties, expressed as Integrated Radius from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
Changes in biomechanical corneal properties, expressed as ARTH from baseline to 12 months
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
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
Time frame: From baseline up to 12 months post-procedure
Changes in Vision Related Quality of Life (VRQoL) from baseline to 12 months
Time frame: At screening visit (preoperatively) and at study end (12 months post-procedure)
Stability of the corneal applanation between 6 and 12 months
Time frame: Between 6 and 12 months post-procedure
Changes in optical quality expressed as RMS from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
Changes in optical quality expressed as OSI value from baseline to 12 months
Time frame: From baseline up to 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Sponsor official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rossella Baldini, PhD contact
Edoardo Grosso, MD study director
Chief Medical Officer (CMO)
José L. Güell, MD principal investigator
Head of the Cornea, Cataract and Refractive Surgery Department at IMO
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitinol net for intracorneal implant for keratoconus treatment in people with Keratoconus, run by Recornea Srl at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emiliano Lepore, Ing., PhD (+39 3209673891, el@recornea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Adverse Device Effects (SADE), Adverse Events (AE), and Serious Adverse Events (SAE) (time frame: From enrolment up to 12 months post-procedure). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.