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Twelve-Month Clinical and Histopathological Performance of a Novel Synthetic Cornea Device in Rabbit Model
Esen Karamursel Akpek1, Anthony J Aldave2, Guillermo Amescua3
1The Ocular Surface Disease Clinic, The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Translational Vision Science & Technology
|August 10, 2023
Summary
This study evaluated a new flexible synthetic cornea in rabbits, finding it biologically stable with good outcomes. This artificial cornea shows promise for restoring vision in patients unsuitable for traditional transplants.
Area of Science:
- Ophthalmology
- Biomaterials Science
- Regenerative Medicine
Background:
- Corneal blindness remains a significant global health issue.
- Donor keratoplasty success is limited in high-risk patients due to graft failure.
- Novel synthetic corneal devices are needed to address unmet clinical needs.
Purpose of the Study:
- To assess the biological stability and postoperative outcomes of a second-generation, single-piece, flexible synthetic cornea.
- To evaluate the biointegration and long-term performance of the synthetic cornea in a rabbit model.
Main Methods:
- A novel synthetic cornea device with enhanced biointegration features was implanted into rabbit eyes.
- Sixteen devices were implanted into an intrastromal pocket, with follow-up at 6 and 12 months.
- Corneal integration, intraocular pressure, and ocular health were monitored via clinical exams and optical coherence tomography.
Main Results:
- No intraoperative complications were observed, and all devices remained in situ with clear optics.
- No retroprosthetic membrane, glaucoma, cataract, or retinal detachment occurred.
- Histopathology revealed fibroplasia and collagen deposition within the porous scaffold, with minimal inflammation.
Conclusions:
- The synthetic corneal device demonstrated favorable biological stability and postoperative outcomes in a rabbit model.
- The device shows potential for vision restoration in patients at high risk for donor graft failure.
- Human feasibility studies are planned based on these promising preclinical results.
