To the Editor:
I read Ms. Kearns' news report entitled "Homemade Excimer Lasers Are Operating Today in the US--The Rest of the Country Watches and Waits" in the July/August issue of the Journal of Refractive Surgery (1995;11:229-233).
The article did a fine job of addressing legal issues related to the use of custom (and hopefully more advanced) excimer lasers. Your comments regarding my work were incomplete, in some cases incorrect, and unfortunately misleading.
My excimer laser was developed in the 1980s and was first used for a patient in 1990. I had considered using a Summit laser when they became available but felt that the then available beam diameter of 4.5 mm was too small. I asked them to build a larger one; they said it could not be done. I said I didn't think patients should be subjected to this small of a beam and continued toward building one with a goal of an 8-mm beam (it has been proven that my intuition was correct). I also envisioned using a microkeratome between the patient and the laser and developed a larger working distance. There are other differences as well, including my laser's capability to treat astigmatism and hyperopia, in addition to myopia.
I developed intrastromal ("on the bed") use of the excimer laser (LASER-K {SM} [LASIK]) independently, and believe I may have been the first surgeon to perform this procedure.
There was no attempt to circumvent the FDA on safety and efficacy issues. I was simply trying to take care of my patients in the best way possible.
We started using the instrument at a very slow pace and developed protocols for PTK, PRK, and LASER-K {SM} (LASIK). PRK may be relatively safe and effective, but it is not as good as LASER-K {SM} for most refractive patients. I initially used LASER-K for higher myopes unilaterally, and gradually increased its range to include lower myopia, astigmatism, and hyperopia. This work was done under treatment protocols reviewed by our IRB. Data has been carefully collected, and demonstrates accuracy, safety, and efficacy.(1) Over a slow transition in my practice, LASER-K displaced refractive keratotomy and ALK because it is the better way to treat most patients. They are more comfortable, have more rapid recovery, and fewer side effects.
My staff contacted the FDA at the outset of my excimer laser work and was advised of the existence of the "physician exception for custom device." We met the criteria. Others at the FDA have recently indicated they would not like the law to exist and have tried to interpret it differently. After talking to multiple staff members at the FDA, I believe that they are ordinary people like you and me who are simply trying to do a good job. Their job is to regulate manufacturers in order to protect patients. It is unfortunate that pioneers making advances in ophthalmology--ie, lens implantation, phacoemulsification, corneal transplantation, refractive keratotomy, argon laser trabeculoplasty, to name a few--are forced to suffer the indignations of the type that were in your article. LASER-K (LASIK) is a very significant advance in refractive surgery. It would be nice for someone to just say "thank you" instead of looking for things to complain about.
About SLACK Inc.
Go to Eye Care Internet Resources.
Go to Journal of Refractive Surgery.
Look up abstracts (open to all visitors).
Look up full articles (ISRS
members, only).
Try out a free issue.
Take out a subscription.
Copyright 1995, SLACK Incorporated. Revised 18 November 1995.
Send a letter to the editor.
Comment to Webmaster,
SLACK Inc.