In Vivo Implantation Of The Grosso® Shape-Memory Implant For Corneal Shape And Strength Restoration
Published 2024 - 42nd Congress of the ESCRS
Reference: PP21.16 | Type: Free paper | DOI: 10.82333/g6zc-m709
Authors: Neil Lagali* 1 , Maria Xeroudaki 2 , Petros Moustardas 1 , Edoardo Grosso 3 , Laetizia Mansutti 4 , Laura Gonzalez 5 , Anna Nolla Del Saz 5 , Emiliano Lepore 6
1Biomedical and Clinical Sciences,Linköping University,Linköping,Sweden, 2Ophthalmology,Linköping University Hospital,Linköping,Sweden, 3Ophthalmology,Studio oculistico Grosso,Torino,Italy, 4Ophthalmology,Blue Eye Clinic,Milan,Italy, 5Ophthalmology,IMO,Barcelona,Spain, 6Recornea Srl,Trieste,Italy
Purpose
The GROSSO® corneal implant is an ophthalmic medical device made of nitinol, designed to restore corneal shape when pathologically deformed. Here we report preclinical results after implantation in the rabbit cornea to reshape and strengthen the corneal tissue to treat topographic and ectatic corneal disorders.
Setting
Faculty of Medicine, Linköping University, Sweden in a licensed facility for surgery and postoperative care.
Methods
The right eye of 20 New Zealand white albino rabbits was operated using a femtosecond laser to create an access cut and 9.5mm diameter corneal midstromal pocket. In 8 controls the corneal pocket was manually separated while in the GROSSO® group with 12 rabbits, the device was inserted in the intrastromal pocket. Intraocular pressure, tomography, topography and biomechanics were evaluated before operation and at 1 week and month 1, 2, 3 and 6. Haze and neovascularization scoring was used to assess the inflammatory reaction to the implant.
Results
Surgeries were successfully completed. Eecentric pocket creation in many cases was due to rabbit eye anatomy. Postoperative keratitis occurred in 3 eyes (2 GROSSO®, 1 control). Postoperative stromal haze subsided to preoperative levels by 3 months. Neovessels were detected in 5 GROSSO® and 2 control eyes at 1 month, and treated with topical steroids for 2 weeks, resulting in vessel regression. Surgeries and GROSSO® implantation did not alter intraocular pressure or corneal thickness, but significantly reduced the flat, steep and average keratometry relative to controls. The biomechanical strength of the GROSSO® implanted corneas was significantly increased relative to controls.
Conclusions
The GROSSO® implant could be safely implanted in the cornea using a laser-assisted surgery. Some postoperative complications were present in both treatment groups, while decentration and possible foreign body response were contributing factors to neovessels in some cases, that could be conservatively managed. Although astigmatism did not differ between groups due to implant decentration, there was significant flattening in the GROSSO® corneas relative to controls, demonstrating a shape-modifying effect and additional biomechanical strengthening of the cornea.