Unmet NeedCorneal blindness affects an estimated 10 million people worldwide, particularly prevalent in the underdeveloped world. Currently, only about 10% of patients receive a corneal transplant due to a shortage of human donor corneas and difficulty in preserving the tissues. Meanwhile, even in countries with a sufficient donor supply, some patients cannot tolerate human corneal grafts. About 8,000 people in the U.S. are unable to receive human donor corneas annually because the damage caused by their corneal diseases will cause the human tissue transplants to fail. The alternative to donor corneas are artificial plastic corneas, which can be mass produced without the difficult preservation requirements. In addition, there is no risk of rejection with artificial corneas in patients who are not good candidates for donor corneas. However, existing artificial corneas are not fully artificial because they require a human donor cornea as a carrier material to suture the artificial cornea into the recipient eye. Also, post-operation complications such as glaucoma, melt, retroprosthetic membrane formation, and infection occur more frequently in artificial corneas compared to donor corneas, and these complications may lead to failure and loss of vision even loss of the eye. Thus, there is an unmet need for fully artificial corneas that minimize post-operative complications.
Technology OverviewThe artificial cornea is fabricated from a soft, flexible, and transparent derivative of Teflon that possesses similar optical properties to human cornea tissue. The material is chemically inert which enables it to be easily stored for long periods of time, and will not be rejected by the patient’s immune system. It is comprised of an optical part that focuses light and a porous skirt that bonds to the patient’s surrounding recipient cornea. The formation of biological bonds between the device and the patient’s eye is distinct from existing artificial corneas because it enables the device to be transplanted without the use of human donor tissue as a carrier. Initial rabbit studies with this device did not demonstrate occurrence of glaucoma, retroprosthetic membrane or retinal detachment.
Stage of DevelopmentThe inventor jointly completed a prototype with W.L. Gore & Associates.
In vivo preclinical studies were completed in rabbits, and the results indicated that the rabbits were free of common post-operation complications including immune rejection, retinal detachment, cataract and glaucoma. The inventors are planning on conducting human clinical trials by 2025 to gain U.S. Food and Drug Administration clearance.
