Small Incision Artificial Cornea

描述（由申请人提供）：本拨款提案的目的是进行一项临床研究，该研究将允许第一个可折叠和可注射的人造角膜KeraKlear在美国市场上用于治疗角膜失明。这种装置可以通过切口植入，切口大小大约是美国最流行的人工角膜切口大小的十分之一。与目前可用的人工角膜相比，较小的切口尺寸有望使患者更快地进行手术，并更快地恢复。此外，KeraKlear人工角膜可以在许多角膜失明患者中植入，而无需进入前房。这避免了人工角膜植入的两种最严重的并发症，包括眼内感染（眼内炎）和严重出血（排出性出血）。KeraKlear人工角膜的使用也避免了角膜移植常见的并发症，包括角膜高度散光、角膜移植失败和角膜移植排斥反应。最后，KeraKlear将使更多的患者能够治疗角膜失明。目前，由于缺乏合适的角膜供体，全世界每年的角膜移植数量限制在10万例左右。这只占全世界双眼角膜失明的1000万人中的1%。通过制造KeraKlear人工角膜，世界上很大比例的角膜失明患者可以得到治疗。

DESCRIPTION (provided by applicant): The objective of this grant proposal is to perform a clinical study which will allow the first foldable and injectable artificial cornea, the KeraKlear, to be used in the United States market for treatment of corneal blindness. This device may be implanted through an incision size that is approximately 1/10th the size of the incision that is required for the most popular artificial cornea available in the U.S. The smaller incision size is expected to allow a much quicker surgery for patients and a more accelerated recovery as compared to the currently available artificial corneas. In addition, the KeraKlear artificial cornea may be implanted in many patients with cornea blindness without penetration into the anterior chamber. This avoids two of the most serious complications of artificial cornea implantation including internal infection of the eye (endophthalmitis) and severe bleeding (expulsive hemorrhage). The use of the KeraKlear artificial cornea also avoids the common complications of corneal transplantation including high astigmatism, corneal graft failure and corneal graft rejection. Finally, the KeraKlear would enable the treatment of cornea blindness in a much larger number of patients. Currently, corneal transplantation is limited to about 100,000 per year worldwide because of the lack of suitable donor corneas. This represents only 1% of the 10 million people worldwide who have cornea blindness in both eyes. By making the KeraKlear artificial cornea available a significantly larger percentage of the cornea blind patients around the world could be treated. PUBLIC HEALTH RELEVANCE: A new type of foldable and injectable artificial cornea has been developed for placement through a small incision (3 mm). In this project, we will perform clinical studies to determine the safety and efficacy of this new device. Successful completion of the study will lead to the availability of this less invasive artificial to cornea blind patients in the U.S.