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Tests treatment safety and results for Keratoconus
Official title First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus
ClinicalTrials.gov ID: NCT06451718
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated informed consent form.
- Male and female ≥ 18 years old.
- Not recommended for ICRS.
- Recommended for keratoplasty.
- Minimum corneal thickness ≥ 350 μm.
You likely can't join if
- 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...
- 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).
See the full eligibility criteria
- 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).
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Roma, Italy
- Barcelona, Bar, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Roma, Italy; Barcelona, Bar, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.