Buzz
LASIK is often praised for being a quick and convenient procedure, offering immediate vision correction without the need for glasses or contact lenses. However, this isn’t always the case for every patient. The FDA is emphasizing the need for prospective patients to be aware of the risks and potential side effects that can arise.
What are the possible risks associated with LASIK surgery?
LASIK surgery reshapes the cornea, the transparent layer covering your eye’s pupil. The procedure involves creating a flap in the cornea, removing tissue with a laser, and replacing the flap. This process can cause nerve damage that takes time to heal. While most patients see improvements within a day or two, full healing can take longer. One of the most common side effects in the initial recovery phase is dry eyes, affecting 85% of patients a week after surgery. Dry eyes can cause blurred vision and discomfort, but eye drops usually help alleviate the symptoms.
If the nerves that were cut don’t heal properly, symptoms like dry eye may continue for months or years. Other complications can also occur, and these are more common if you have certain health conditions, including diabetes or allergies, or if your cornea is already very thin before surgery.
The surgery also isn’t guaranteed to give you 20/20 vision; many people need to continue wearing glasses or contacts even after a surgery that improves their vision.
How common are complications from LASIK?
The FDA has been working on a draft document that discusses what these complications are, and who is most likely to get them.
Six months after the surgery, according to the FDA, 27% of patients still have dry eyes, and 41% have visual problems like glare, halos, starbursts, or double vision. These visual problems can make it difficult or impossible to do tasks like driving at night. At the six-month mark, 2% of people report “a lot of difficulty” or “so much difficulty that I can no longer do some of my usual activities” without glasses or contacts.
While these symptoms tend to improve over time, not everyone will experience the same outcome. The FDA requires patients to sign an acknowledgment form that outlines the following statistics five years after the surgery:
Approximately 17% of patients may still need to use eye drops daily to manage dry eyes.
Fewer than 2% of patients report experiencing visual disturbances such as glare, halos, starbursts, and double vision.
About 8% of patients may have moderate to significant difficulty seeing in low-light conditions, making night driving challenging.
There are very rare reports (less than 0.8% of cases) of severe, persistent pain that may interfere with daily activities.
Who is at a higher risk of experiencing complications from LASIK?
The FDA’s document also provides a checklist of factors that could increase the likelihood of enduring complications. These include existing medical conditions and lifestyle factors such as engaging in contact sports or needing sharp vision in low-light conditions, such as frequent night driving.
Contraindications, or situations where you should avoid the surgery, include:
Existing dry eyes
A cornea that is too thin (your eye doctor can assess the thickness of your cornea)
Autoimmune disorders
Uncontrolled glaucoma
Uncontrolled diabetes
Additionally, there are conditions and activities that do not outright prevent you from undergoing LASIK, but may warrant further consideration. The draft document suggests discussing potential risks with your doctor if you have less severe forms of the above conditions, such as taking medications that cause dry eyes, or having well-controlled glaucoma or diabetes. Conditions like crossed eyes or reduced vision in one eye are also considered cautionary factors. (For a complete list, which includes more conditions not mentioned here, refer to the draft document.)
Not all LASIK clinics fully disclose the risks involved
If complications from LASIK are so common, why isn't there more discussion about them? Perhaps I'm being cynical, but one possible reason is marketing. LASIK is straightforward and efficient from the doctor's perspective, which is why some clinics specialize in it with large advertising budgets. As LASIK typically isn’t covered by insurance, and costs usually exceed $2,000 per eye, it’s a lucrative procedure for doctors who can perform it in as little as 15 minutes, as pointed out in this analysis in an ophthalmology journal.
That same paper highlights that LASIK clinics often offer discounts to attract patients for preoperative evaluations and follow-up treatments. It’s easy to see how some clinics might emphasize the positive aspects of the surgery over the risks, especially when financial incentives are involved.
As reported by the New York Times reports, the FDA has been refining its draft document for years, and the latest version has attracted over 600 comments, many from surgeons who believe the draft paints a too negative picture, potentially discouraging patients unnecessarily.
In short, the FDA is concerned that surgeons aren't adequately discussing the possible downsides of LASIK before patients agree to the procedure. It’s crucial to understand both the risks and benefits of any medical procedure, particularly an elective one like LASIK that you may choose to undergo instead of relying on glasses or contacts. Other eye surgeries exist to correct vision, each with its own risks and benefits.
