By Elisabeth Leamy, Correspondent, The Dr. Oz Show
If you decide to go forward with LASIK eye surgery, be an educated patient. After all, you only have one set of eyes and they are one of your precious five senses! Here's advice on how to proceed with caution.
Read more about The Dr. Oz Show's investigation about the potential risks of LASIK surgery here.
1. Assess the risks versus benefits. Critics say the LASIK complication rate is about 20%, if you include complications like dry eye pain and night vision difficulty. Supporters say 95% of LASIK patients are satisfied, which means 5% are not. The truth may lie somewhere in between. Since LASIK is an entirely elective procedure, decide whether that range of potential risk is acceptable to you. It is not possible to know whether you will be among the patients who are thrilled with their LASIK results or one of those who has long-term difficulties.
2. Consider doing one eye at a time. Because it is impossible to know for sure whether you will have a good LASIK result, one option is to have LASIK performed on only one eye at a time. That way, if you have a bad result, at least you are still left with one good eye. During the time period when each eye has a different prescription, you simply wear a contact lens in one eye or use glasses that have just one corrective lens. Even the FDA endorses this precaution, saying, "Although the convenience of having surgery on both eyes on the same day is attractive, this practice is riskier than having two separate surgeries... If both eyes are treated at the same time... you and your doctor do not have the advantage of being able to see how the first eye responds to surgery before the second eye is treated."
3. Avoid LASIK if you have these risk factors:
Dry eyes: If you already have uncomfortably dry eyes — especially if an ophthalmologist has diagnosed you with dry eye syndrome — LASIK could make this condition worse, according to the FDA.
Thin corneas: Because in LASIK a flap is cut in your cornea, it's important that you have enough corneal tissue left over to hold your eyeball together and prevent bulging. Though there is a debate over whether people with thin corneas may safely undergo LASIK, conventional wisdom holds that after LASIK you should have at least 250 microns of cornea left.
Large pupils: Doctors disagree about whether large pupils are a risk factor when treated with the latest lasers, but the FDA says they can be. While the debate continues, here’s the prudent course of action: Find out what your pupil measurement is when your pupils are fully dilated in low light conditions and ask your doctor if the "treatment area" (the area reshaped by the laser) is safe to use with your pupil size.
Night vision needs: If your work or hobbies require you to drive a lot at night or see well at night, you may want to avoid LASIK. Night vision difficulties have been identified in multiple studies as the second most common LASIK complication.
4. Read the Patient Information Booklet. There is a Patient Information Booklet or PIB for every laser on the market, but despite the name, doctors are not required to give them to patients. These booklets contain detailed data on the performance of the lasers used to perform LASIK as documented during clinical trials conducted to get FDA approval. It is a wealth of information that patients rarely see. Here's a random sampling of the data in the PIBs:
- The FDA clinical trial for one laser shows that nine months after LASIK 10% of patients had lost more than 2 lines of visual acuity on an eye chart, compared to what they used to be able to see with glasses.
- Clinical trial data for a different brand of laser shows that six months after LASIK 20% of patients complained of "night vision with glare" and said they were "somewhat dissatisfied" or "very dissatisfied."
- The clinical trial for a third brand of laser compared patient symptoms before LASIK with those same symptoms nine months after LASIK; 34% of patients reported that their dryness was worse or significantly worse after LASIK.
Clearly, Patient Information Booklets contain important information to consider. Here's how you can access them:
- Get the make and model. Ask for the make and model number of the laser that your chosen doctor uses. (Be sure to get the detailed model number because many manufacturers make an entire line of lasers with the same name but add new model numbers over the years.)
- Go to the FDA's list of approved lasers. Fortunately, the LASIK Patient Information Booklets are available on the FDA website. Unfortunately, they're not easy to find. So here is a direct link to every LASIK laser ever approved.
- Find the laser your doctor uses. Scroll to it. Keep in mind that they are organized according to the date they were approved rather than alphabetically.
- Click on "Labeling, Approval Order, Summary of Safety and Effectiveness." You will see this in the far right column of the table under "Device or Consumer Information/Instructions."
- Click on "Labeling," "Professional Labeling" or "Patient Labeling." The FDA has allowed different companies to call these different things. For some companies, the Professional Labeling for doctors and the Patient Labeling for consumers are lumped together. For others, the two are separate.
- Scroll down to the "Patient Information Booklet" or PIB. Alternatively, you can hit "Control F" to bring up a search box and type in "Booklet" to get to the Patient Information Booklet without scrolling.
- Look for key tables. The text of the patient information booklets is very dense, but you should really read it all. However, you can read it out of order and a good place to start is the tables of information on patient outcomes. Look for tables on things like visual acuity, patient symptoms, complication rates and adverse events.
5. Consider other eye surgeries. The precursor to LASIK was PRK or "Photorefractive Keratectomy," but just because it came first doesn't mean it's an inferior surgery. It could be better for some patients. In PRK, instead of cutting a flap, the surgeon uses a sterile brush to remove the very outer layers of the cornea, then reshapes the cornea with a laser. Because there is no flap, that eliminates one area of possible complications.
- Get a "K Card." Having LASIK surgery now can have an impact on whether you can have successful cataract surgery later, if needed. Have your doctor fill out what's called a "K Card" with your pre-LASIK eye measurements. Those measurements will help a future eye doctor calculate the correct "lens implant power" needed during cataract surgery.