Device for Facilitating Corneal Transplantation

描述(申请人提供)：常见的角膜疾患，如Fuchs内皮营养不良、人工晶状体大泡性角膜病变和疱疹病毒性角膜炎。全球每年约有100,000例角膜移植手术用于治疗角膜视力丧失。虽然角膜移植手术被普遍认为是成功的，但最常见的技术-穿透性角膜移植(PK)-已经有40多年的历史了，并且有一些明显的缺点。PK的缺点是手术时间长(1~2小时)，恢复时间长(6~12个月)，术后经常出现大量散光，扭曲视力，并有致盲并发症的风险，包括排出性脉络膜出血和眼内炎。这些并发症中的大多数与目前的PK技术直接相关，PK技术是通过360度切开切除全厚度组织盘。通过使用角膜内袋进行角膜部分厚度移植，有可能避免PK的许多并发症。我们已经开发了一种机械设备，可以在活体或供体角膜内自动创建角膜袋，用于部分厚度角膜移植。该装置的使用将缩短角膜移植的手术时间和恢复时间，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包括在人类身体全眼和人类供体角膜上测试原型装置。测试参数将包括测量口袋的尺寸和深度。计划外的结果，如口袋不完整，也将被记录下来。我们还将进行扫描电子显微镜研究，以确定由该设备创建的口袋的平整度，并将其与手动制作的口袋进行比较。从第一阶段研究中获得的信息将被用来建造该设备的商业版本，用于第二阶段临床研究。

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.