Transitioning the Minimally Invasive Artificial Cornea (mi-KPro) from Bench to Bedside: A Safer Alternative for the Treatment of World s Corneal Blindness
Abstract
Severe ocular injuries, as frequently encountered in the military, can lead to blindness even if promptly treated. Excessive scarring, abnormal blood vessel formation (neovascularization), and loss of limbal stem cells significantly reduce that success of standard transplantation surgery. In these patients, vision restoration can be achieved only by using an artificial cornea, typically made of plastic and titanium, positioned in the front part of the eye as a window. Indeed, 20,000 patients have already benefited from such artificial corneas, which are developed in our laboratory and have been approved by the U.S. Food and Drug Administration (FDA) and the European Union. The Boston Keratoprosthesis artificial cornea is a collar button window that is implanted surgically in the eye and functions as a regular human cornea. Although short- and mid-term outcomes are excellent, in terms of device retention and vision restoration, long-term complications often compromise vision. Two major post-operative complications often encountered clinically are glaucoma and the intraocular infection, both attributed to the penetrating nature of the device. These complications, however, can be eliminated or minimized by redesigning a less invasive artificial cornea. To this end, we developed a minimally invasive artificial cornea, the mi-KPro, that is implanted within the corneal tissue with a non-penetrating surgical procedure. The optical cylinder is then inserted inside the eye through a very small incision, while the remaining device is placed on the surface of the eye. This results in minimal post-operative complications, while providing excellent vision restoration, unobscured from corneal opacities. Animal studies with the mi-KPro have shown that it is well retained in the eye for more than a year, can replace the injured cornea after chemical burn, and most importantly, does not induce glaucoma nor infection even without providing any eyedrops medication for a year. The encouraging preclinical results provides groundwork to transition to a pilot human study. Successful results from a pilot study in humans would help to treat Service Members that incurred severe ocular injuries, but also to treat existing traumas in Veterans that have resulted in corneal blindness. We also expect significant public benefit given that 1.5 - 2 million patients become corneal blind every year, and many of them require artificial cornea to restore their vision. Although 1,500 artificial corneas are implanted every year, this number is expected to increase significantly if we develop an artificial cornea with low post-operative complications. We believe that this is an important project for the military and public. According to recent reports, the number of eye trauma between 2000 and 2010 among active military members was approximately 186,555 (ambulatory and hospitalized cases) with an annual cost of $382,905,615 due to blindness. The projected lifetime costs to military members with eye injuries or vision impairment is estimated to be $24 billion. Corneal blindness is a leading cause of blindness with 1.4 million blind people per year in the general population. In recent wars, civilian injuries have shifted from bullets to burns, with one out of four burn injuries caused by explosives. Likewise, during peace-time, industrial accidents are responsible for two-thirds of civilian burns. Ocular burns comprise about 7%-18% of all ocular traumas presented to the emergency room in the United States with 84% of them being chemical burns. These numbers depict the impact of ocular trauma to the military and to the public. The proposed artificial cornea may significantly improve the outcomes of severe ocular traumas and reduce complications, which together will vastly bring down the medical cost to the military and the public. Both the military and civilian patients will benefit from the mi-KPro, due to the ease of implantation, its lo
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310906
Entities
People
- Eleftherios Paschalis Ilios
Organizations
- Massachusetts Eye and Ear Infirmary
- United States Army