Keratoconus
Progressive bulging of the corneaAbout Keratoconus
The cornea is the outermost lens of the eye, which controls light entry and is responsible for most of the eye's focusing power. Any change in the shape of the cornea has a significant impact on a person's ability to see, affecting their day-to-day life and autonomy.
Keratoconus is the most common cause of corneal deformity: this ocular alteration produces a progressive thinning of the central zone of the cornea, changing its usual spherical shape into a conical one. As a result, images are perceived distorted and vision decreases successively with poor quality of life for these patients.
GROSSO® Reshaper
Revolutionizing corneal care with advanced nitinol technology.
With its innovative design, GROSSO® Reshaper mechanically restores natural corneal curvature, dramatically improving vision for keratoconus patients.
The GROSSO® Reshaper is a patented ground-breaking solution in the form of an intra-corneal implant, made out of nitinol, a shape memory alloy with a long history for use in medical device development.
The GROSSO® Reshaper is designed to mimic the normal anatomic curvature of a healthy cornea. When inserted in a circular corneal pocket, the implant will predictably improve vision in patients with stage 2, 3 and 4 keratoconus by mechanically restoring and maintaining the normal anatomic shape of the cornea and eliminating the bulging.
Demonstrated significant corneal flattening in preclinical rabbit study, associated with K1 reduction of 7D, K2 and Kave reduction of 5-6D with follow-ups up to 6 months.
Designed to bend without breaking and withstand daily wear while retaining its shape. - evidenced in explanted pig eye and human cornea testing.
Shown to be safe and well-tolerated in both in vitro and in vivo testing.
Public grants
HUMANeye, a European-funded project revolutionizing eye care.
HUMANeye is the first European clinical research project coordinated by the Institute of Ocular Microsurgery (IMO) Foundation, funded by the Innovation Council (EIC) through the European Horizon 2020 initiative "Fast Track to Innovation".
With corneal diseases a major cause of blindness worldwide (second only to cataracts) and current treatments inadequate, the HUMANeye project has pioneered an implantable solution, requiring only minimal surgery.
Corrective laser surgery typically doesn't work, while transplantation and implants (acting as micro-prostheses) often prove unpredictable, leaving contact lenses and spectacles to be prescribed at the earliest stages.
The EU-funded HUMANeye project has developed and tested a shape-memory corneal implant, the GROSSO® Reshaper, to treat KC.
The development of this project was possible thanks to the collaborative work of several European entities: the IMO Foundation, promoter and coordinator of the project; RECORNEA (Italy), an SME in the techno-health sector in charge of developing the prototype; and doctors José Luis Güell of IMO Grupo Miranza (Spain) and Pierre Fournie of the University Hospital of Toulouse (France), who will develop the clinical trials to validate its effectiveness.
NiTi4EYE, an injector for standardized minimally invasive surgery
Recornea received the grant “Linea C” from the Autonomous Region of Friuli Venezia Giulia in Italy, in collaboration with the Cluster for Life Sciences. This grant supports the development of an injector for the GROSSO Reshaper in order to offer a minimally invasive surgery which will be easy for any surgeons and standardized for any patients.
Through this project, we hope to be able to develop a universal implant that will restore the cornea to its normal shape and thus significantly improve the vision of patients suffering from keratoconus.
Dr José Luis GüellHead of the Cornea, Cataract and Refractive Surgery Department of IMO Grupo Miranza and Principal Investigator of the First In Human clinical trial of the GROSSO® stent.
Thanks to a curvature similar to that of natural corneas, when bonded with corneal tissue, the GROSSO® stent recovers vision predictably, completely and precisely.
Laura GonzálezProject coordinator from IMO Grupo Miranza
Clinical Trial
The REMKERA First In Human clinical trial is now on-going at the Institute of Ocular Microsurgery (IMO) in Barcelona, Spain.
For more information about clinical trials please visit clinicaltrials.gov.
Patients
Discover the stories of patients living with keratoconus. At Recornea, we are dedicated to improving their quality of life through innovative medical devices and ongoing clinical investigations.
Interview with Loredana Incorvaia
Interview with Annalisa Bronzino
Intellectual Property
The GROSSO® Reshaper are protected by patents and trade secrets by Recornea.