Interim Results Of The First In Human Study For The First Nitinol Grosso® Reshaper For Treatment Of Advanced Keratoconus
Published 2026 - 44th Congress of the ESCRS
Reference: FP30.03 | Type: Free paper | DOI: 10.82333/hqc8-4h61
Authors: Dr Edoardo Grosso* 1 , Dr Carlos Rocha-de-Lossada 2 , Ms Laura González Rosales 3 , Ms Sandra Suescun Busto 3 , Ms Laura Zahiño Lora 3 , Ms Ana Nolla Del Saz 3 , Dr Romina Fasciani 4 , Dr Luigi Mosca 4 , Dr Simone Bruzio 4 , Dr Graziana Maria Ragonese 1 , Dr Rossella Baldini 1 , Dr Moses Kakanga 1 , Dr Emiliano Lepore 1 , Prof. José Luis Güell 3
1Recornea Srl,Trieste,Italy, 2Hospital Regional Universitario de Málaga,Malaga,Spain, 3Instituto de Microcirugía Ocular (IMO), Miranza Group ,Barcelona,Spain, 4Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Eye Clinic-Cornea and Refractive Service,Rome,Italy
Purpose
To assess the safety profile and the anatomical and functional efficacy in humans of the GROSSO® Reshaper, a newly conceived implantable nitinol device, for the treatment of stage 3 and 4 keratoconus through a first in human clinical trial currently ongoing in the two approved sites in Spain and in Italy.
Setting
Instituto de Microcirugía Ocular (IMO), Miranza Group, Barcelona, Spain.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Eye Clinic-Cornea and Refractive Service, Rome, Italy.
Recornea Srl, Trieste, Italy.
Methods
12 subjects fulfilling a comprehensive set inclusion and exclusion criteria are planned in the ongoing FIH study for the GROSSO® Reshaper in Spain and Italy. The subjects have follow-up visits on postoperative days 1, 7, 21, 60, 180 and 365 to evalute corneal reshaping, biomechanical reinforcement and vision rehabilitation in advanced keratoconus. Examinations include slit-lamp examination to evaluate safety, corneal imaging to quantitatively measure efficacy and patient-reported symptom questionnaire. In 6 months from now, we will have completed all surgeries with 6 month follow-up for 3 patients and up to the 2 month follow-up for the remaining 8 patients, plus the one patient already followed up to 1 year completing the study.
Results
No severe device-related AEs are reported showing excellent safety and integrity in the cornea. IOP has physiological values and the endothelial cell count has no significant changes. BDSCVA improvements are from 2 to 4 lines for all patients showing functional efficacy. Topographic and refractive analyses show a marked improvement in corneal regularity and visual performance. Anterior corneal astigmatism decreases from 6.5 to 1.7 D at 1 year. The keratometric profile decreases from 53.5 D to 49.6 D at 1 year, proving effective anterior corneal flattening. Anterior curvature gaussian maps show clear improvement of vertical symmetry of the topographical pattern as well as evidence of corneal regularization effect where the device is present.
Conclusions
Our findings suggest that the GROSSO® Reshaper represents a promising new therapeutic paradigm in patients with advanced keratoconus, given drawbacks of current therapeutic approaches and the global shortage of donor corneal tissue. The proposed minimally invasive approach preserves the patient’s own corneal tissue while strengthening it. Vision improvement in advanced cases of keratoconus demonstrates the potential of the reshaping effect of the GROSSO® Reshaper coupled with an excellent safety profile and integration in the corneal tissues.