The article was reporting on the FDA's updated guidelines regarding LASIK and Laser Vision Correction safety. This past summer, an early draft was released and, unfortunately, it did not provide a balanced perspective of the risks/benefits of the generally safe surgery. In fact, I believe it was unnecessarily alarmist in tone and had multiple inaccuracies. Since this draft has come out, many ophthalmologists, including myself, have been trying to set the record straight.
In the FDA’s own quality of life study (PROWL study*), satisfaction rates with postoperative vision after LASIK ranged from 96% to 99% and satisfaction rates from the surgery, in general, ranged from 98% to 99%. This was not mentioned in the FDA report.
I have much more to say on this topic, so check out my full interview below!
Dr. Tsong's Full Interview with BuzzFeed News:
BuzzFeedNews: With the FDA’s draft guidance update, how important is this updated list of risks and complications for individuals thinking about LASIK?
This is a very important document which many patients will reference for guidance and understanding of LASIK. That being said, I have a lot of problems with the FDA's draft guidance update.
The tone and balance of the draft guidance is overly negative towards LASIK. There are no statistics of what % of patients are satisfied with their surgical results, for example. The FDA's study Patient-Reported Outcomes with LASIK (PROWL) Study reported:
Satisfaction rates with postoperative vision ranged from 96% (95% CI 93%-98%)
to 99% (95% CI, 96%-100%) and satisfaction rates from surgery ranged from 98%
(95% CI 95%-99%) to 99% (95% CI 96%-100%).
I don't think a guidance update is even necessary and what they produced is not helpful. The FDA approved LASIK surgery in 1999 and the risks/benefits of surgery is routinely covered in the informed consent process between a physician and patient. The informed consent is much more important because, rather than being a generalized document, a doctor will have a verbal discussion (which includes a doctor's customized written consent form) of the specific risks/benefit for a particular patient - personalized to that patient's particular situation.
Other issues I have with this:
They quote statistics and list risks but don't provide references to evidence-based articles.
Many of the listed risks are false and misleading.
There are publications that call into question many of the warnings mentioned: controlled glaucoma, controlled autoimmune or connective tissue
disease, a weakened immune system, amblyopia.
I can go on with other examples...
BuzzFeed News: Some doctors think that the FDAs draft guidance might cause more fear around the surgery, do you believe this draft was beneficial?
The draft guidance is not beneficial at all. I think the FDA should have worked closer with ophthalmologists and their respective societies (ASCRS, the American Society of Cataract and Refractive Surgeons) to provide more balanced and more accurate guidance.
This draft also left out the fact that laser technology has improved dramatically since LASIK was first approved in 1999. So risk of certain visual symptoms such as glare, halos, or difficulty with night driving is much lower than in the past. Think about all the advances that must have occurred since 1999! They should have included more updated data and updated references. I think this is a missed opportunity to provide updated information to patients.
BuzzFeed News: Is there anything you do specifically to inform patients about both benefits and risks surrounding the surgery beforehand?
Like I said before, it's important for a doctor to address both the potential benefits and risks for a particular patient's situation. Every patient is different. This is much more important than any draft guidance.
For patients that are very worried about surgery, I recommend that they get consultations with at least 2 different LASIK surgeons. That way, if the patient passes both doctor's screening tests and is considered a "good candidate" by both surgeons, this provides added reassurance to move forward with surgery.