OSU Retrospective Study Results & Language Approved By FDA!

Ran into Mark Bullimore at the AAO in San Francisco. That is the same Dr. Bullimore of Ohio State University and the huge retrospective study sponsored by Paragon Vision Sciences and B&L.

Great news!

M. Bullimore, From OSU Faculty WebsiteThe FDA has accepted the findings and language of the study and will label Ortho-K lenses with a risk factor no different then SCL's as far as the incidence of eye infections including microbial keratitis.The study was done to answer questions that had come up about the safety of corneal reshaping particularly with children.The FDA when it orginally approved the CRT lenses for overnight corneal reshaping did not include an age limit to the procedure. With reports surfacing over the years particularly from Asia about cases of microbial keratitis and children the FDA had reopened that whole issue. I participated in this study and; let me tell you it was professionally run and administered. If you had any questions that needed answering they were done in a timely fashion and quite thoroughly. We all owe a giant thank you to Paragon Vision Sciences and Bausch and Lomb for funding this study that will finally answer in full the safety issues faced with overnight corneal reshaping.

- Cary Herzberg OD FOAA