SBIR-STTR Award

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.

The goal of this 2 year long Phase II research project is to develop a 510(k) FDA approved robotic microkeratome device using that will automatically create a large (> 8 mm) uniform pocket through a small incision (< 3.5 mm) within a live human cornea. The device uses robotic principles to move a thin blade in 3 different axes which allows the microkeratome to create a substantially round pocket through a small incision. By providing a uniform pocket in a live or donor cornea, corneal transplantation may be performed more safely, quickly, and with better visual outcomes. In addition, the ability to create relatively large corneal pockets through a small incision may provide new and improved methods to implant intracorneal lenses and keratoprostheses. At the present time there is no commercially available device which allows the automatic creation of a uniform pocket in an opaque cornea. Our primary milestone for the Phase II study will be to demonstrate the ability of our FDA approved device to automatically create uniform pockets in live human eyes with corneal blindness and limited visual potential.

Public Health Relevance:
We are developing a robotic device which will be able to make a large uniform pocket in the cornea of a live human cornea through a small incision. Corneal transplantation may be performed more safely, quickly, and with better visual outcomes through the use of this device. In addition, the ability to create relatively large corneal pockets through a small incision will provide new and improved methods to implant intracorneal lenses and artificial corneas.

NIH Spending Category:
Assistive Technology; Bioengineering; Clinical Research; Clinical Trials; Eye Disease and Disorders of Vision; Transplantation

Project Terms:
Blindness; Computer software; Consult; Cornea; corneal surgery; design; device Artificial lens; Devices; Electronics; Exclusion Criteria; Eye; Failure (biologic function); Family suidae; FDA approved; Goals; Human; human subject; Implant; improved; Keratoplasty; lens; Life; meetings; Methods; Motor; Operative Surgical Procedures; Outcome; Patients; Phase; Phase II Clinical Trials; public health relevance; Recruitment Activity; Research Project Grants; robotic device; Robotics; Safety; Sterility; Suction; Surgeon; Surgical incisions; System; Time; Training; Vacuum Pumps; Visual