Small Incision Artificial Cornea

描述（由申请人提供）：本资助提案的目的是进行一项临床研究，该研究将使第一个可折叠和可注射的人工角膜KeraKlear在美国市场上用于治疗角膜失明。该装置可以通过切口尺寸植入，该切口尺寸约为美国最流行的人造角膜所需切口尺寸的1/10。与目前可用的人造角膜相比，较小的切口尺寸预计将允许患者更快地进行手术并更快地恢复。此外，KeraKlear人工角膜可植入许多角膜盲患者体内，而不会穿透前房。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人工角膜的使用还避免了角膜移植的常见并发症，包括高度散光、角膜移植失败和角膜移植排斥。最后，KeraKlear将能够治疗更多患者的角膜失明。目前，由于缺乏合适的供体角膜，全世界每年的角膜移植仅限于约10万例。这仅占全世界1000万双眼角膜失明患者的1%。通过提供KeraKlear人工角膜，世界各地的角膜失明患者中有更大比例的人可以得到治疗。

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.