Comparison Of Two Techniques For Implantation Of The Grosso Reshaper In The Cornea For The Treatment Of Keratoconus

Published 2025 - 43rd Congress of the ESCRS

Reference: PP02.06 | Type: Free paper | DOI: 10.82333/8ge8-7c65

Authors: Haifeng Jiang* ¹ , Yong Wang ¹

¹Cataract,Aier eye hospital of Wuhan University(Wuhan Aier Eye Hospital),Wuhan,China

Purpose

This study aims to compare two techniques for implanting the GROSSO® Reshaper in the cornea: manual implantation versus implantation using a delivery device, focusing on the differences in corneal tissue damage post-implantation and operative time.The GROSSO® Reshaper is an investigational device currently being evaluated in a First In Human clinical trial

Setting

Recornea Srl, Trieste, Italy

Faculty of Medicine, Linköping University, Sweden, in a licensed facility for surgery and postoperative care

Methods

The GROSSO® Reshaper is a new intrastromal nitinol device used for the treatment of keratoconus. Twenty ex vivo pig eyes underwent the surgical procedure: 10 eyes through manual implantation and the other 10 using a delivery device. The manual technique consists of introducing the device with tweezers into a femtosecond laser corneal pocket, kept bended by a vicryl suture subsequently cut to unfold the implant inside the cornea. A custom injector eliminates the need for a suture, implanting the pre-loaded device directly into the corneal pocket. Both techniques were compared in terms of incision size and operative time. Data regarding the duration of the procedure, incision width and intraoperative complications were collected

Results

Results indicate that the delivery device technique significantly reduced corneal tissue trauma compared to the manual method. Additionally, the use of the injector shortened the operative median time (50 versus 180 seconds), leading to a more efficient and standardized procedure. The injector technique was not affected by any intraoperative complication and was less operator-dependent than manual procedure

Conclusions

The use of the delivery device for the implantation of the GROSSO®Reshaper improves surgical efficiency and repeatability by reducing operative time. These findings suggest that the newly-developed standardized implantation procedure using the injector has shown benefits ex-vivo in terms of reduced tissue trauma, greater reproducibility and quicker procedures which are expected to be confirmed also in the daily clinical practice of surgeries with the GROSSO® Reshaper