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.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44EY016617-03
Application #
7860532
Study Section
Special Emphasis Panel (ZRG1-BDCN-F (12))
Program Officer
Wujek, Jerome R
Project Start
2005-05-01
Project End
2012-05-31
Budget Start
2010-06-01
Budget End
2012-05-31
Support Year
3
Fiscal Year
2010
Total Cost
$535,401
Indirect Cost
Name
Keramed, Inc.
Department
Type
DUNS #
186952748
City
Sunnyvale
State
CA
Country
United States
Zip Code
94089