What are the risks and how can I find the right doctor for me?

Most patients are very pleased with the results of their refractive surgery. However, like any other medical procedure, there are risks involved. That's why it is important for you to understand the limitations and possible complications of refractive surgery. Before undergoing a refractive procedure, you should carefully weigh the risks and benefits based on your own personal value system, and try to avoid being influenced by friends that have had the procedure or doctors encouraging you to do so.

• Some patients lose vision. Some patients lose lines of vision on the vision chart that cannot be corrected with glasses, contact lenses, or surgery as a result of treatment.
• Some patients develop debilitating visual symptoms. Some patients develop glare, halos, and/or double vision that can seriously affect nighttime vision. Even with good vision on the vision chart, some patients do not see as well in situations of low contrast, such as at night or in fog, after treatment as compared to before treatment.
• You may be under treated or over treated. Only a certain percent of patients achieve 20/20 vision without glasses or contacts. You may require additional treatment, but additional treatment may not be possible. You may still need glasses or contact lenses after surgery. This may be true even if you only required a very weak prescription before surgery. If you used reading glasses before surgery, you may still need reading glasses after surgery.
• Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required.
• Results are generally not as good in patients with very large refractive errors of any type. You should discuss your expectations with your doctor and realize that you may still require glasses or contacts after the surgery.
• For some farsighted patients, results may diminish with age. If you are farsighted, the level of improved vision you experience after surgery may decrease with age. This can occur if your manifest refraction (a vision exam with lenses before dilating drops) is very different from your cycloplegic refraction (a vision exam with lenses after dilating drops).
• Long-term data are not available. LASIK is a relatively new technology. The first laser was approved for LASIK eye surgery in 1998. Therefore, the long-term safety and effectiveness of LASIK surgery is not known.

Monovision

Monovision is one clinical technique used to deal with the correction of presbyopia, the gradual loss of the ability of the eye to change focus for close-up tasks that progresses with age. The intent of monovision is for the presbyopic patient to use one eye for distance viewing and one eye for near viewing. This practice was first applied to fit contact lens wearers and more recently to LASIK and other refractive surgeries. With contact lenses, a presbyopic patient has one eye fit with a contact lens to correct distance vision, and the other eye fit with a contact lens to correct near vision. In the same way, with LASIK, a presbyopic patient has one eye operated on to correct the distance vision, and the other operated on to correct the near vision. In other words, the goal of the surgery is for one eye to have vision worse than 20/20, the commonly referred to goal for LASIK surgical correction of distance vision. Since one eye is corrected for distance viewing and the other eye is corrected for near viewing, the two eyes no longer work together. This results in poorer quality vision and a decrease in depth perception. These effects of monovision are most noticeable in low lighting conditions and when performing tasks requiring very sharp vision. Therefore, you may need to wear glasses or contact lenses to fully correct both eyes for distance or near when performing visually demanding tasks, such as driving at night, operating dangerous equipment, or performing occupational tasks requiring very sharp close vision (e.g., reading small print for long periods of time).

] Many patients cannot get used to having one eye blurred at all times. Therefore, if you are considering monovision with LASIK, make sure you go through a trial period with contact lenses to see if you can tolerate monovision, before having the surgery performed on your eyes. Find out if you pass your state's driver's license requirements with monovision.

In addition, you should consider how much your presbyopia is expected to increase in the future. Ask your doctor when you should expect the results of your monovision surgery to no longer be enough for you to see near-by objects clearly without the aid of glasses or contacts, or when a second surgery might be required to further correct your near vision.

Bilateral Simultaneous Treatment

You may choose to have LASIK surgery on both eyes at the same time or to have surgery on one eye at a time. 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 you decide to have one eye done at a time, you and your doctor will decide how long to wait before having surgery on the other eye. If both eyes are treated at the same time or before one eye has a chance to fully heal, 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.

Another disadvantage to having surgery on both eyes at the same time is that the vision in both eyes may be blurred after surgery until the initial healing process is over, rather than being able to rely on clear vision in at least one eye at all times.

Finding the Right Doctor

If you are considering refractive surgery, make sure you:

• Compare. The levels of risk and benefit vary slightly not only from procedure to procedure, but from device to device depending on the manufacturer, and from surgeon to surgeon depending on their level of experience with a particular procedure.
• Don't base your decision simply on cost and don't settle for the first eye center, doctor, or procedure you investigate. Remember that the decisions you make about your eyes and refractive surgery will affect you for the rest of your life.
• Be wary of eye centers that advertise, "20/20 vision or your money back" or "package deals." There are never any guarantees in medicine.
• Read. It is important for you to read the patient handbook provided to your doctor by the manufacturer of the device used to perform the refractive procedure. Your doctor should provide you with this handbook and be willing to discuss his/her outcomes (successes as well as complications) compared to the results of studies outlined in the handbook.
• Even the best screened patients under the care of most skilled surgeons can experience serious complications.
• During surgery. Malfunction of a device or other error, such as cutting a flap of cornea through and through instead of making a hinge during LASIK surgery, may lead to discontinuation of the procedure or irreversible damage to the eye.
• After surgery. Some complications, such as migration of the flap, inflammation or infection, may require another procedure and/or intensive treatment with drops. Even with aggressive therapy, such complications may lead to temporary loss of vision or even irreversible blindness.

Under the care of an experienced doctor, carefully screened candidates with reasonable expectations and a clear understanding of the risks and alternatives are likely to be happy with the results of their refractive procedure.

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FDA Role

FDA’s Authority

FDA regulates the sale of medical devices in the U.S. and monitors the safety of all regulated medical devices.

In the U.S., FDA regulates the sale of medical devices such as the lasers used for LASIK. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use.

The FDA does not have the authority to:

• Regulate a doctor's practice. In other words, FDA does not tell doctors what to do when running their business or what they can or cannot tell their patients.
• Set the amount a doctor can charge for LASIK eye surgery.
• "Insist" the patient information booklet from the laser manufacturer be provided to the potential patient.
• Make recommendations for individual doctors, clinics, or eye centers. FDA does not maintain nor have access to any such list of doctors performing LASIK eye surgery.
• Conduct or provide a rating system on any medical device it regulates.

FDA monitors the ongoing safety and efficacy of all regulated marketed devices, through these problem reporting programs:

• MedWatch, the FDA Safety Information and Adverse Event Reporting Program. MedWatch allows reporting of serious problems related with drugs and medical devices from:
     o Manufacturers
     o Health care professionals and Consumers
• SightNet is a program through which health care professionals at participating facilities can share concerns about potential safety issues with ophthalmic medical devices, and report problems to FDA.
  

LASIK - FAQs (Frequently Asked Questions)

• Can you refer me to a good LASIK surgeon in my area?
• How do I report a bad experience or who do I notify about a 'bad' doctor?
• much does LASIK cost?
• How can I find out if a particular laser has been approved to treat my refractive error (nearsightedness, farsightedness and/or astigmastism)?
• If the laser I am interested in has not yet been approved for a particular indication, how can I find out when it will be approved?
• Which laser is the best for treating my refractive error?
• How does wavefront LASIK compare to conventional LASIK?
• What percentage of patients attain 20/20 vision or better without glasses or contacts?
• What is “All-Laser LASIK” and how does it compare to traditional LASIK surgery?
• Can I use information from the FDA LASIK website?
  

Q: Can you refer me to a good LASIK surgeon in my area?
A: Refer to the Other Resources section of this site. You may want to contact the organizations listed there for additional information. While FDA regulates medical devices and drugs, FDA does not regulate the practice of medicine and does not have a registry of doctors. FDA does not know of any government agency that can provide a referral for any medical procedure. You may want to go to your library and see if there is a local community services magazine that may provide comparison information of services for doctors in your area.

Q: How do I report a bad experience or who do I notify about a 'bad' doctor?
A: If you had a bad experience or sustained an injury, you should file a voluntary MedWatch report (1-800-FDA-1088) to the FDA. Also, you could contact your state medical licensing board and file a complaint with them. In addition, you could contact your state health department or consumer complaint organization (e.g., Better Business Bureau).

Q: How much does LASIK cost?
A: The FDA regulates the safety and effectiveness of medical devices for their intended use. The FDA does not regulate the marketing of or any fees associated with the use of that product. Again, you may want to go to your library and see if there is a local community services magazine that may provide comparison information of services for doctors in your area.

Q: How can I find out if a particular laser has been approved to treat my refractive error (nearsightedness, farsightedness and/or astigmastism)?
A: You can find approved devices, their approval date, and a synopsis of the approved indications on the FDA-Approved Lasers page.

Q: If the laser I am interested in has not yet been approved for a particular indication, how can I find out when it will be approved?
A: Confidentiality restrictions prohibit FDA from commenting on the status of a device under regulatory review, but you can try asking the laser company for this information.

Q: Which laser is the best for treating my refractive error?
A: FDA does not provide comparisons between refractive lasers. FDA approves the safety and effectiveness of a device independent of any other product. However, you are encouraged to review the approval documents to assess the capabilities of specific laser systems and make your own comparisons. The approval number for each laser on the FDA-Approved Lasers page is linked to these documents, which provide additional, detailed information about the clinical trial results and indications for use. Discuss any concerns you may have with your doctor.

Q: How does wavefront LASIK compare to conventional LASIK?
A: Wavefront adds an automatic measurement of more subtle distortions (called higher order aberrations) than just nearsightedness, farsightedness, and astigmatism corrected by conventional LASIK. However, these “higher order aberrations” account for only a small amount (probably no more than 10%) of the total refractive error of the average person’s eye. Conventional LASIK increases higher order aberrations. Although wavefront-guided treatments attempt to eliminate higher order aberrations, results from the clinical studies have shown that the average aberrations still increase, but less than they do after conventional LASIK. In a few studies comparing wavefront-guided LASIK to conventional LASIK, a slightly larger percentage of subjects treated with wavefront LASIK achieved 20/20 vision without glasses or contact lenses compared to subjects treated with conventional LASIK. Patient selection (“When is LASIK not for me?”) and the experience and competence of the surgeon are still the most important considerations.

Q: What is “All-Laser LASIK” and how does it compare to traditional LASIK surgery?
A: The difference between traditional LASIK and “All-Laser LASIK” (also known as “Bladeless LASIK”) is the method by which the LASIK flap is created. In “All-Laser LASIK”, a laser device called a laser keratome, is used to cut a corneal flap for LASIK surgery. This is a newer method to create a corneal flap than the traditional method of using a microkeratome, a mechanical device with a blade. There is no absolute agreement among eye surgeons on the better choice for flap creation. Some of the factors a surgeon considers when choosing a preferred method of flap creation during LASIK are as follows:

• Quality of vision
• Rate of complications
• Pain during and after surgery
• Precision of flap size and thickness
• Time to recovery of vision
• Expense

Discuss with your doctor any questions and concerns you have about how they chose their preferred method of flap creation.

Q: What percentage of patients attain 20/20 vision or better without glasses or contacts?
A: Data in the Approval Orders and related documents summarizes the outcomes from the clinical trials submitted to the FDA for each approved device. Links to these documents are included on the FDA-Approved Lasers page.

Q: Can I use information from the FDA LASIK website?
A: Yes. Information on this website can be used freely by the public. Any use on other websites or in publications should be properly cited.