The Dry Eye Zone

Rebecca's Blog

-

4/25/08 FDA LASIK Hearing: The afternoon session

The afternoon session proceeded as follows:

1. FDA PRESENTATION (1.5 hours)

A team of 6 FDA staffers presented material ranging from basic background information on what the FDA does and their regulatory role in LASIK before and after device approvals to the "Quality of Life Assessment" they are now in the process of planning.

The only very substantive part of this from my perspective was Dr. Eva Rorer's presentation on the QOL. I have concerns with the scope and nature of this study's objectives, but even more so with the involvement of ASCRS in the study itself. It has been abundantly clear in ASCRS' press releases over the past month or so and even more so in the course of the morning's proceedings that it is in their interests to focus as much as possible of the attention on patient satisfaction, a measure of success which in refractive surgery pretty much never fails to produce industry-friendly results.

What is much more needful is to study the quality of life impact on patients with poor outcomes, which specific complications of surgery are most likely to impact quality of life and in what degree. This message, whether explicit or implicit, came across loud and clear from consumers/patients during the morning. For heaven's sakes, at least 5 suicides were talked of, and almost every speaker with complications or representing someone with complications talked of permanent visual distortion, chronic severe pain or both. One of the strongest and most consistent messages from the morning was that consumers consider dry eye and vision quality loss to be serious complications, and that doctors do not, either in the pre-operative "informed consent" process or in post-operative assessment and treatment.

2. GUEST SPEAKER DAVID TANZER MD (15 minutes)

I've covered this in a previous blog post.

3. FDA QUESTIONS AND PANEL DISCUSSION (1 hour)

The agenda for this session was 4 items:

a. Recommendations for changes to patient labelling of excimer lasers.
b. Recommendations for changes to FDA's LASIK website.
c. Whether the FDA should recognize the ANSI...(I won't get into all the details on this) in whole or part.
d. Recommendations for additions to a list of adverse events & complications of LASIK in the SightNet reporting system.

I suspect most readers will not be interested in the minutiae of this discussion. I will go ahead and jump to the bottom line, or at least so much of it as caught my interest personally.

THE GOOD NEWS

The FDA will be making some very important additions to warnings on the website and product labelling including:

- Warnings about potential complication to future cataract surgery. (For those of you not familiar with this issue, having LASIK can make it much more difficult for a cataract surgeon to accurately calculate the power of the lens required when you eventually need cataract surgery.)

- Warnings about potential complication for intraocular power measurement. (Again for those not in the know: IOP measurement can be less accurate after LASIK. A bad IOP measurement is not something you want. I've known people to have serious scares over possible glaucoma diagnosis. Doctors and consumers need to know so that they get repeat measurements & second opinions.)

- Warnings about loss of near vision. Many people do not understand that if they are nearsighted and are say 40 or over, having their vision corrected by LASIK may mean they will no longer be able to read without reading glasses.

By the way: I think that Paula Cofer from Tampa (a complications patient) deserves a great deal of credit for pushing for these changes. She was in attendance as FDA consumer representative and in that capacity had the opportunity to participate in the ODP/FDA discussion.

- It was agreed that a very misleading chart about post LASIK dry eye on the website would be removed or revised.

There was a great deal more, but these are some of the key ones I recall as being 'consumer triumphs'.

THE BAD NEWS

As one of the speakers pointed out, what's on the website is immaterial if people don't read it, and what's in the Patient Information Booklet is immaterial if doctors don't give it to their patients. The FDA has no authority to make doctors do anything at all.

And that latter is really the crushing point from the whole meeting, whatever of minor triumphs can be salvaged from it. The biggest consumer grievances with LASIK are things the FDA has no authority to do anything about. Which brings us to...

4. CLOSING COMMENTS

Dr. Weiss (Chair) had 4 closing comments:

1. She stated that the vast majority of LASIK patients are happy and see well, and emphasized the rarity of complications.

2. She talked of complaints about aggressive marketing (actually, very little had been said about this in the public hearing, but never mind) and explained that this is NOT AN FDA ISSUE, but rather an FTC issue.

3. She talked of problems with informed consent and again stated that this is not an FDA issue but is rather a question of malpractice.

4. She stated that some of the press seemed to be expecting that the meeting would be a referendum on LASIK but that in fact it was more of a referendum on some surgeons who should be doing a better job.
RebeccaComment