A Minimally Invasive Artificial Cornea for Vision Restoration in Severely Injured Eyes
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. In these patients, vision restoration can be achieved using an artificial cornea, typically made of plastic and titanium, positioned in the front part of the eye as a window. Indeed, 15,000 patients have already benefited from such artificial cornea, which was developed in our laboratory and was approved by the FDA 10 years ago. The device is a collar button window that is implanted surgically in the eye and functions as a regular human cornea. Although short- and mid-term outcome 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 Flex-KPro, that is implanted within the cornea through a non-penetrating surgical procedure. The optical cylinder is then inserted inside the eye through a 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. Two consecutive animal studies with previous versions of the Flex-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 or infection even without providing any eye-drops medication for a year. These exciting results were translated into a new version of the Flex-KPro that is intended for all types of eye traumas. We request support from the DoD to perform that final animal evaluation using four different corneal injury models: alkali, acid, thermal, and penetrating injury, in preparation for clinical translation in a pilot human study. We expect that the new device will result in long-term vision restoration, will be retained by the eye, and will produce minimal, if any, intraocular complications. Such device, if successful, can be used to treat Service members who 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 million to 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. 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 approximately 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 t
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010916
Entities
People
- Eleftherios Paschalis Ilios
Organizations
- Massachusetts Eye and Ear Infirmary
- United States Army