Device for Facilitating Corneal Transplantation

Period of Performance: 03/01/2006 - 02/28/2008


Phase 1 SBIR

Recipient Firm

Keramed, Inc.
Sunnyvale, CA 94089
Principal Investigator


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.