Early Postoperative Conjunctival Complications Leading to Exposure of Surgically Implanted CorNeat EverPatch Devices.

PURPOSE

To compare the early exposure and surgical revision rates between a new synthetic tissue substitute (CorNeat EverPatch) with that of human donor cornea after placement onto the scleral surface during ophthalmic surgery and study the biomaterial properties of the synthetic patch material.

DESIGN

Retrospective comparison study and biomaterial analyses of new and explanted synthetic patch material.

PARTICIPANTS

All consecutive patients who underwent ophthalmic surgery with implantation of the CorNeat EverPatch at the Wilmer Eye Institute (occurring from February through August 2024) and a comparison group who underwent ophthalmic surgery with implantation of irradiated donor cornea, matched 1:2 with patients receiving EverPatch for age, type of glaucoma, and surgeon.

METHODS

Retrospective review of clinical electronic medical records of patients who underwent surgery at the Wilmer Eye Institute. Materials characterization of EverPatch, including morphologic features, surface roughness, wettability, thermal stability, elemental analysis, and physical properties.

MAIN OUTCOME MEASURES

Early exposure (within 5 months of surgery) and surgical revision rates after CorNeat EverPatch or irradiated human donor cornea implantation during ophthalmic surgery.

RESULTS

Thirty patients undergoing ophthalmic surgery in 2024 received EverPatch implantation during primary tube shunt placement (n = 27), tube shunt revision (n = 2), or covering of exposed suture used for scleral fixation of an intraocular lens (n = 1). During the early postoperative period, the rate of EverPatch exposure was 48.3% and the rate of surgical revision was 27.9%. In case-matched control participants (n = 58), the rate of patch graft exposure was 1.7% (P < 0.0001) and the rate of surgical revision was 1.7% (P < 0.0001). EverPatch devices constituted a randomly aligned fibrous mesh with an average fiber diameter of 1.36 ± 0.78 μm, surface roughness of 1.3 ± 0.1 μm, pore size of 3.7 ± 0.4 μm, and percent porosity of 37 ± 3%. Explanted EverPatch devices demonstrated varying degrees of tissue integration with significantly increased wettability and changes in thermal stability and elemental composition.

CONCLUSIONS

The rate of early conjunctival complications leading to exposure of the CorNeat EverPatch was higher than that of irradiated human donor corneal patch grafts. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.