June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Safety assessment of the CorNeat EverPatch - a novel, non-degradable, synthetic tissue substitute for ophthalmic surgery, in an animal model
Author Affiliations & Notes
  • Ido Klein
    Clinical, CorNeat Vision Ltd, Israel
  • Footnotes
    Commercial Relationships   Ido Klein CorNeat Vision Ltd., Code E (Employment)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 4254. doi:
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      Ido Klein; Safety assessment of the CorNeat EverPatch - a novel, non-degradable, synthetic tissue substitute for ophthalmic surgery, in an animal model. Invest. Ophthalmol. Vis. Sci. 2023;64(8):4254.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To evaluate the local reaction and the histopathological changes following implantation of the CorNeat EverPatch, in comparison to a commercial Reference Device, Tutoplast Processed Sclera.

Methods : A total of 12 New Zealand White rabbits were implanted with the CorNeat EverPatch in one eye and a Reference Device in the contralateral eye. Both patches were implanted under the conjunctiva and sutured to the underlying sclera. Throughout the observation period, eyes were evaluated by a veterinary ophthalmologist, by means of slit lamp biomicroscopy, fluorescein staining and indirect ophthalmoscopy. Ten and 2 animals were euthanized at 3 and 6-months, respectively. At termination, the eyes were enucleated, examined microscopically, fixed, and subjected to histopathological processing, staining (H&E) & evaluation.

Results : Ocular findings were limited to expected, minimal conjunctival congestion and swelling observed within the 1st month after surgery in both treatments. Histological findings of the CorNeat EverPatch implanted eyes comprised of an expected, minor foreign body reaction, including a thin connective tissue capsule and some mononuclear cell infiltration noted at the periphery of the patch while fibroblasts were seen within the patch. A more robust reaction was noted in the Reference Device implanted eyes and included a substantial, mixed mononuclear cell infiltration made predominantly of lymphocytes. In both groups, no incidental lesion was noted in other segments of the eye.

Conclusions : The CorNeat EverPatch is the first and only synthetic alternative to tissue and as such showed excellent local tolerability 3- and 6-months post implantation. Furthermore, histopathological evaluation demonstrated progressive integration of the implant within the surrounding tissue.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

 

<div style="direction: ltr;">Representative Color Macro Photographs of Eyes & Implantation Sites</div>

<div style="direction: ltr;">Representative Color Macro Photographs of Eyes & Implantation Sites</div>

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