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Minimally invasive Keratoprosthesis (mi-KPro) for vision restoration in severe ocular chemically injuries.
Eleftherios Paschalis Ilios
Presenter:
Jyoti Sharma1, Thomas Dohlman1, Chengxin Zhou1, Peter York2, Fengyang Lei1, Jie Liu1, Robert J. Woods2, Claes H. Dohlman1, James Chodosh3, Roberto Pineda1, Eleftherios I. Paschalis1
Authors:
Affiliation:
1. Harvard Medical School - Mass. Eye and Ear
2. Harvard Engineering
3. University of New Mexico
Purpose: Severe ocular injuries often lead to corneal blindness. Artificial corneas have changed the prognosis and have become the mainstay in vision restoration. Still, long-term complications, such as secondary glaucoma, endophthalmitis, and retroprosthesis membrane (RPM) frequently occur. Here we present a new minimally invasive KPro (mi-KPro) that reduces such complications. It consists of elongated optical stem, uses duplicate Descemet’s membrane entry ports, and has an ultra-thin, flexible titanium backplate within the corneal stroma. Here we test the new design in models of corneal burns.
Methods: Severe corneal alkali or acid burns were achieved using 2N NaOH (n=12) or 2N HCL (n=12), respectively. One month later, injured corneas were restored either by using the mi-KPro or with standard penetrating keratoplasty (PKP) (control). Implantation of the mi-KPro device was achieved using deep anterior lamellar keratoplasty (DALK) for backplate placement and a 2.5mm diameter central Descemet membrane trephination for insertion of the optical stem into the anterior chamber. PKPs were performed using a 8mm trephine. A donor corneal graft was used in all surgeries. Eyes received temporary tarsorrhaphy for 7 days and followed monthly for 1 year using biomicroscopy, anterior and posterior segment optical coherent tomography (OCT), and intracameral pressure measurements. No eye drop prophylaxis was administered beyond the first 3 weeks of the surgery. Ocular tissues were collected for further histological analyses using hematoxylin and eosin and p-Phenylenediamine staining.
Results: The anatomic retention of the mi-KPro was 100% in 1 year after acid burn and 100% in 6 months after alkali burn in rabbits. In contrast, all standard PKP eyes (n=12) exhibited rapid graft failure within 4 months. The new mi-KPro design did not cause intraocular pressure elevation!, glaucoma, RPM, or infection at 1 year. In contrast, all PKP eyes exhibited refractory IOP elevation (p=0.004, n=12), thinning of the retina (n=6, p=0.004), and optic nerve degeneration (n=6, p=0.01) within 4 month of the surgery.
Conclusion: Our data suggest that mi-KPro achieves excellent anatomic retention in chemically injured rabbit eyes for a year, does not lead to RPM formation, and most importantly, does not cause IOP elevation or glaucoma. This design is ready for clinical trials.
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