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Assessing a novel synthetic keratoprosthesis and corresponding surgical procedure: 6 months ocular implantation study in the rabbit

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First Author: G.Litvin ISRAEL

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Abstract Details

Purpose:

To evaluate the integration and safety parameters of an artificial cornea, the CorNeat KPro, in rabbits.

Setting:

Good Laboratory Practice (GLP) New Zealand White Rabbit trial carried out at Envigo CRS labs in Nes Ziona, Israel

Methods:

The CorNeat KPro is a permanent corneal implant designed for treating cornealy blind patients. The KPro utilizes a polymeric bio-integrating skirt to assimilate synthetic optics within resident ocular tissue. The implanting procedure entails corneal trephination and insertion of the optical element of the device into the trephined circular opening in the cornea, and a 360° peritomy for placing the skirt between the sclera and conjunctiva. Eight rabbits were clinically observed for 6 months and evaluated with slit lamp biomicroscopy by an ophthalmologist. At termination, eyes were evaluated histologically for local tissue integration and inflammatory response with the devices in-situ.

Results:

The surgical procedure was found feasible with minimal intraoperative complications. The Corneat KPro integrated into all operated eyes resulting in retention rate of 100% at the end of the 6-month follow-up period. Minimal-mild conjunctival and iridial congestion was observed, yet no inflammatory indicators such as fibrin, flare or cells in the anterior chamber (AC) were observed. The optical element of the device remained clear with zero incidence of retroprosthetic membrane (RPM) formation. Histopathological evaluation revealed comparable tissue and cellular reaction in all eyes consisting of mild presence of fibroblasts associated with formation of collagen fibrils within the device’s skirt component and a mild foreign body reaction in some of the eyes.

Conclusions:

The CorNeat KPro was well tolerated in rabbits. Clinical and histological findings were indicative of excellent integration of the implanted device as evidenced by the outstanding retention rate and the diffuse infiltration of fibroblasts with collagen deposition among the fibrils composing the device’s skirt. This data holds promise for clinical application in humans planned to start during 2020 (received IRB and Ministry of Health approvals).

Financial Disclosure:

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