The Latest FDA and LASIK News: What You Need to Know

You may be seeing reports about the FDA looking into LASIK, which might have you questioning whether the popular vision correction is safe. Rest assured, the FDA is firm in its position that LASIK is both safe and effective for those who are good candidates. In fact, the FDA’s own independent study, PROWL, confirms these facts:

• PROWL study participants reported very high satisfaction rates between 96 and 99 percent
• More than 97% of participants achieved 20/20 vision from LASIK
• The prevalence of visual symptoms and dry eye decreased after having LASIK and improved over time
• Very few study participants reported their symptoms impacted their daily activities or well-being

But what is the FDA doing that is causing all this concern? This year, the FDA is working to ensure the public is well informed about the risks and benefits of LASIK, a goal LASIK surgeons share. The FDA has developed a draft of patient education material about LASIK risks to support patients considering the procedure. As part of the normal protocol for the FDA, in July, the draft document was made public so everyone could review it and provide comments.  The FDA is now reviewing those public comments to inform its next steps.

“The stories that we hear about happy patients with this life-changing procedure are everyday occurrences,” Dr. Vance Thompson told EyeWorld. “This highly successful procedure that impacts people in such a positive way does have a small but important percentage of patients who have issues. It’s valid to have discussions about how to improve patient communication surrounding the procedure to ensure patients are receiving adequate informed consent.”

Because the benefits of LASIK are well understood, the current version of the FDA’s draft document focuses on the small potential for risks, side effects, and complications to make sure people clearly understand them as well. That is what has been getting the spotlight in the news recently. Surgeons, clinicians, researchers, and companies involved in LASIK procedures also make a tremendous amount of information available to patients, because well-informed patients are more likely to have a good experience with and outcome from LASIK. 

“The informed consent discussion includes the risks, the more common temporary side effects, and any potential healing issues, so the patient isn’t scared. It’s not unusual for patients to forget some of this information, and that is why keeping in touch with your doctor, so he or she can make sure you are doing well, is so important,” continued Dr. Thompson. “Informed consent, preoperative education, and postoperative care are all necessary for patients to make a balanced decision on whether or not to have the procedure and to understand what’s worrisome or not postoperatively so they can go through this process with as much inner peace as possible.”

LASIK surgeons have a vested interest in well-informed patients and, therefore, invest time and resources into the process of educating patients on the LASIK procedure.  Patient education is taken very seriously, and surgeons offer patients a variety of resources to support each person’s decision-making.  In addition to the LASIK consultation and follow-up visits or calls, educational material is shared in the office as well as on practice websites to ensure patients have ready access to information.

“One of the most caring things we can do as physicians is getting to know patients well enough—their goals and desires, their eye health, their personality, their patience level, their expectations—and combine their situation with our knowledge and expertise so we can put ourselves in their shoes and give them a heartfelt recommendation on whether to do nothing or consider vision correcting procedure,” said Dr. Thompson. “Even though LASIK is the most common refractive surgical procedure we do, the best LASIK outcomes happen with a comprehensive and caring approach like this. Refractive surgeons take our patient education, recommendations, and informed consent very seriously.”

 A few touch points of patient education leading up to a patient getting LASIK include:

1.            The LASIK consultation. This thoughtful and thorough evaluation of a patient’s eyes and vision is an essential first step. The diagnostic and personal information gathered in consultation drives the personalization of the education about LASIK, or any procedure, to meet the specific visual and lifestyle needs of the patient.

2.            Throughout the process, patients are given information in a variety of formats, encouraged to ask questions, and weigh the pros and cons of LASIK as it pertains to their personal circumstances.

3.            Patients are encouraged to do their own independent research, using credible, clinically accurate, and updated sources of information.  RSC is one such resource that has been serving the educational needs of vision correction patients for more than a decade with thoughtful, well-referenced content that helps patients understand what to expect before and after a LASIK procedure, what questions to ask and how to make an informed decision.

4.            Finally, all the information is codified in the informed consent document every patient must sign to consent to have LASIK.  This important form clearly explains the potential for risks and side effects related to LASIK and, therefore, requires thoughtful review and consideration before signing.

The process of choosing to have LASIK or any vision correction procedure is best done in partnership with a highly qualified surgeon you have confidence in and who is eager to answer your questions on your options, and your specific vision and vision correction needs. You should feel completely comfortable with your surgeon to discuss your concerns about potential risks and what benefits you can expect from a procedure like LASIK.