Actively Recruiting
First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus
Led by Recornea Srl · Updated on 2026-01-20
12
Participants Needed
2
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Male and female 18 years old or older
- Not recommended for Intrastromal Corneal Ring Segments (ICRS)
- Recommended for keratoplasty
- Minimum corneal thickness of 350 micrometers or more
- Best Distance Spectacle Corrected Visual Acuity (BDSCVA) of 0.30 logMAR (0.50 decimal) or better
- BCVA with rigid gas permeable contact lens 10 letters or more than BCVA with spectacles
- Stable or stabilized keratoconus for at least 12 months (if crosslinking done, it must be at least 12 months prior)
- Keratoconus stage 3 or 4 with central K reading over 47.2 diopters and RMS coma aberration over 2.5 micrometers
- No known or suspected allergy to nickel
- Female participants of childbearing potential must not be pregnant or breastfeeding, must agree to use highly effective contraception, and abstain from egg donation or storage during the study
You will not qualify if you...
- Inability to understand clinical investigation procedures or give informed consent
- Untreated progressive keratoconus
- Having only one functioning eye
- Other eye diseases such as eyelid malposition, uveitis, ocular hypertension, glaucoma, cataract, retinal disorders
- Previous corneal surgeries except corneal crosslinking
- Systemic collagen diseases, vasculitis, or other diseases contraindicated by the investigator
- Known or suspected intolerance or allergy to treatments or device components such as nickel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Roma, Italy, 00168
Not Yet Recruiting
2
Instituto de Microcirugía Ocular de Barcelona (IMO)
Barcelona, Bar, Spain, 08035
Actively Recruiting
Research Team
E
Emiliano Lepore, Ing., PhD
CONTACT
R
Rossella Baldini, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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