Where Is The FDA Investigational Status?
In the off-shore clinical trials that started in January 1994, phase I and II have been completed in 1997 and 1998 and yielded exceptionally good results. Expected in the first quarter of 2000, large scale clinical studies will enter 3rd phase in US and so far, right on track. Optimum lens design as well as dose/response studies are ongoing. A new stabilizing agent has been added to the trials that dramatically shorten the time from months to weeks to stabilize the cornea after it has been reshaped. Reducing the recovery time should also limit noncompliance.
