First-in-Human Clinical Trial of a Fish Scale Based Biomaterial for the Emergency Management of Corneal Perforations

Abstract

Purpose : Acute corneal perforations need rapid closure to avoid intraocular infections or suprachoroidal bleeding. The worldwide lack of donor corneas delays the emergency therapy. The current study investigates the efficacy and safety of a fish scale based biomaterial (ologen™ Biocornea) for temporary wound closure for a maximum of 72 hours until a donor cornea is available.

Methods : This is a first-in-human prospective, uncontrolled, interventional, multicenter pilot study (Trial registration number: Eudamed database CIV-15-03-013305). Patients with corneal perforation or laceration with the indication of emergency corneal transplantation were included when a corneal graft was not immediately available. Institutional ethics committee approvals were obtained, the patients provided written informed consent, and the study was performed according to the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. Ologen™ Biocornea was applied on the recipient’s cornea aligning the center of the ologen™ Biocornea with the corneal defect. The ologen™ Biocornea was then fixed onto the cornea by intrastromal 10-0 nylon single sutures. The main outcome measure was effectiveness in closing the perforated cornea until a donor cornea is available. Primary safety endpoints were severe inflammatory anterior chamber reaction, hypotony, suprachoroidal haemorrhage, choroidal detachment, flat anterior chamber, endophthalmitis and wound leakage.

Results : Seven patients (5 m, 2 f) with corneal perforation due to corneal ulcerations were included. A complete success in closing the perforation was achieved in 7 out of 7 patients. In one patient replacement of loose sutures and anterior chamber tamponade with air were needed to complete wound closure. Further adverse events were conjunctival chemosis and hyperemia, foreign body sensation and intracameral fibrin formation in a patient having infectious keratitis at the time of inclusion. Following keratoplasties were regular in all patients.

Conclusions : Using a fish-scale based “biocornea”, corneal perforations can be temporarily closed to bridge the time until a human donor cornea becomes available. This approach may alleviate missing immediate access to allogeneic donor corneas and potentially also be an option for complete long-term corneal replacement.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.