Small Incision Artificial Cornea

描述(由申请者提供)：这项资助计划的目标是进行一项临床研究，使第一个可折叠和可注射的人造角膜KeraKlear在美国市场用于治疗角膜失明。这种装置可以通过一个大约是美国最流行的人工角膜所需的十分之一的切口植入。与目前可用的人工角膜相比，较小的切口有望使患者的手术速度更快，恢复更快。此外，KeraKlear人工角膜可以在不穿透前房的情况下植入许多角膜失明患者。这避免了人工角膜植入的两个最严重的并发症，包括眼睛内部感染(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常见的并发症，包括高度散光、角膜移植失败和角膜移植排斥反应。最后，KeraKlear将能够在更多的患者中治疗角膜失明。目前，由于缺乏合适的供体角膜，全球每年的角膜移植限制在10万人左右。这只占全球1000万双眼角膜失明患者的1%。通过提供KeraKlear人工角膜，世界各地更大比例的角膜盲人患者可以得到治疗。 公共卫生相关性：一种新型的可折叠和可注射的人工角膜已经开发出来，可以通过一个小切口(3毫米)放置。在这个项目中，我们将进行临床研究，以确定这种新设备的安全性和有效性。这项研究的成功完成将使这种侵入性较小的人造角膜在美国的角膜失明患者中可用。

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.