Device for Facilitating Corneal Transplantation

描述（由申请方提供）：角膜疾病（如Fuchs内皮营养不良、人工晶状体大泡性角膜病和疱疹性角膜炎）导致的视力损害很常见。全世界每年进行约100，000例角膜移植用于治疗角膜视力丧失。虽然角膜移植手术通常被认为是成功的，但最常见的技术，穿透性角膜移植术（PK），已经有40多年的历史，并且有一些明显的缺点。PK的缺点包括手术时间长（1 - 2小时），恢复时间长（6 - 12个月），术后散光量大（导致视力扭曲），以及致盲并发症（包括脉络膜出血和眼内炎）的风险。这些并发症中的大多数与当前采用360度切口切除全层盘状组织的PK技术直接相关。通过使用角膜内囊袋进行部分角膜移植，可以避免PK的许多并发症。我们已经开发了一种机械装置，可以自动在活体或供体角膜内形成角膜囊，用于部分厚度角膜移植。该装置的使用应减少角膜移植的手术和恢复时间，并减少术后散光。此外，对于仅涉及角膜前部的移植，应消除排出性脉络膜出血和眼内炎的风险。我们的第一阶段研究将涉及在人尸体的整个眼睛和人供体角膜上测试原型设备。测试参数将包括测量囊袋的尺寸和深度。还将记录计划外结局，如囊袋不完整。我们还将进行SEM研究，以确定器械创建的囊袋的平滑度，并将其与手动制作的囊袋进行比较。从I期研究中获得的信息将用于构建用于II期临床研究的器械商业版本。

DESCRIPTION (provided by applicant): Visual impairment from corneal disorders such as Fuchs' endothelial dystrophy, pseudophakic bullous keratopathy, and herpes keratitis occurs commonly. Approximately 100,000 corneal transplants are performed worldwide annually for the treatment of corneal visual loss. Although corneal transplantation surgery is generally considered to be successful, the most common technique, penetrating keratoplasty (PK), is over 40 years old and has some distinct disadvantages. Disadvantages of PK include a long surgical time of 1 to 2 hours, a long recovery time of 6 to 12 months, frequently large amounts of post-operative astigmatism which distorts vision, and risk of blinding complications including expulsive choroidal hemorrhage and endophthalmitis. Most of these complications are directly related to the current PK technique of excising a full thickness disk of tissue with a 360 degree incision. It is possible to avoid many of the complications of PK by performing partial thickness transplants of the cornea through the use of an intracorneal pocket. We have developed a mechanical device that can automatically create a corneal pocket within a live or donor cornea for the purpose of partial thickness corneal transplantation. The use of this device should decrease the surgical and recovery time of corneal transplantation and also decrease post- operative astigmatism. In addition, for transplants involving only the anterior portion of the cornea, the risks of expulsive choroidal hemorrhage and endophthalmitis should be eliminated. Our Phase I studies will involve testing of a prototype device on human cadaveric whole eyes and human donor corneas. Testing parameters will include measurement of the dimensions and depth of the pocket. Unplanned outcomes such as incomplete pockets will also be recorded. We will also perform SEM studies to determine the smoothness of the pocket created by the device and compare this to pockets made manually. Information gained from Phase I studies will be used to build a commercial version of the device for use in Phase II clinical studies.