Small Incision Artificial Cornea

小切口人工角膜

• 批准号: 8123583
• 负责人: YICHIEH SHIUEY
• 金额: $ 28.47万
• 依托单位: KERAMED, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-06-01 至 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8123583
• 关键词: Adverse event; Anterior; Applications Grants; Astigmatism; Blindness; Clinical Research; Cornea; Data; Devices; Effectiveness; Endophthalmitis; Eye; Eye Infections; Graft Rejection; Grant; Hemorrhage; Human; Implant; Injectable; Keratoplasty; Lamellar Keratoplasty; Laser In Situ Keratomileusis; Lead; Macular degeneration; Marketing; Measures; National Eye Institute; Operative Surgical Procedures; Outcome; Outcome Study; Patients; Penetrating Keratoplasty; Penetration; Phase; Pilot Projects; Quality of life; Questionnaires; Recovery; Rehabilitation therapy; Reporting; Safety; Staging; Surgical incisions; Techniques; Technology; Testing; United States; Vision; Visual; Visual Acuity; anterior chamber; base; blind; corneal surgery; follow-up; graft failure; implantation; phase 2 study; success

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.

描述（由申请人提供）：该赠款提案的目的是进行临床研究，该研究将允许第一个可折叠和可注射的人造角膜Keraklear在美国市场中用于治疗角膜失明。该设备的切口大小可能是美国可用的最流行人造角膜所需的切口大小的切口大小，预计较小的切口尺寸将允许患者进行更快的手术，并且与当前可用的人工角膜相比，较小的切口尺寸和更加加速的康复。此外，许多角膜失明的患者可能会植入Keraklear人造角膜，而不会穿透前腔。这避免了人造角膜植入的两种最严重的并发症，包括眼睛内部感染（眼内炎）和严重的出血（驱除出血）。 Keraklear人造角膜的使用还避免了角膜移植的常见并发症，包括高散光，角膜移植衰竭和角膜移植的排斥。最后，Keraklear将使大量患者的角膜失明治疗。目前，由于缺乏合适的供体角膜，角膜移植每年仅限于全球约100,000。这仅占全球两只眼睛角膜失明的1000万人中的1％。通过使Keraklear人造角膜可用，可以治疗世界各地的角膜盲患者的百分比。 公共卫生相关性：已开发了一种新型的可折叠和可注射的人造角膜，以通过小切口（3毫米）放置。在这个项目中，我们将进行临床研究，以确定该新设备的安全性和功效。该研究的成功完成将导致美国对角膜盲患者的这种侵入性不那么侵入性人为的可用性