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FAQs

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.
FAQs

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 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.
Learning About LASIK
LASIK stands for Laser-Assisted In Situ Keratomileusis and is a procedure that permanently changes the shape of the cornea, the clear covering of the front of the eye, using an excimer laser

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LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses. The goal of this Web site is to provide objective information to the public about LASIK surgery.

See other sections of this site to learn about what you should know before surgery, what will happen during the surgery, and what you should expect after surgery.

There is a glossary of terms and a checklist of issues for you to consider, practices to follow, and questions to ask your doctor before undergoing LASIK surgery.


LASIK stands for Laser-Assisted In Situ Keratomileusis and is a procedure that permanently changes the shape of the cornea, the clear covering of the front of the eye, using an excimer laser.
A knife, called a microkeratome, is used to cut a flap in the cornea. A hinge is left at one end of this flap. The flap is folded back revealing the stroma, the middlesection of the cornea.

Pulses from a computer-controlled laser vaporize a portion of the stroma and the flap is replaced. There are other techniques and many new terms related to LASIK that you may hear about.

What to expect before, during, and after surgery will vary from doctor to doctor and patient to patient.

NOTE: This section is a compilation of patient information developed by manufacturers and healthcare professionals, but cannot replace the dialogue you should have with your doctor.
What should I expect BEFORE surgery?
If you decide to go ahead with LASIK surgery, you will need an initial or baseline evaluation by your eye doctor to determine if you are a good candidate.
This is what you need to know to prepare for the exam and what you should expect:

If you wear contact lenses, it is a good idea to stop wearing them before your baseline evaluation and switch to wearing your glasses full-time.
Contact lenses change the shape of your cornea for up to several weeks after you have stopped using them depending on the type of contact lenses you wear.
Not leaving your contact lenses out long enough for your cornea to assume its natural shape before surgery can have negative consequences. These consequences include inaccurate measurements and a poor surgical plan, resulting in poor vision after surgery.
These measurements, which determine how much corneal tissue to remove, may need to be repeated at least a week after your initial evaluation and before surgery to make sure they have not changed, especially if you wear RGP or hard lenses.

If you wear:
  • soft contact lenses, you should stop wearing them for 2 weeks before your initial evaluation.
  • toric soft lenses or rigid gas permeable (RGP) lenses, you should stop wearing them for at least 3 weeks before your initial evaluation.
  • hard lenses, you should stop wearing them for at least 4 weeks before your initial evaluation.

Before your initial exam, stop wearing contact lenses.

You should tell your doctor:
  • about your past and present medical and eye conditions
  • about all the medications you are taking, including over-the-counter medications and any medications you may be allergic to

Your doctor should perform a thorough eye exam and discuss:
  • whether you are a good candidate
  • what the risks, benefits, and alternatives of the surgery are
  • what you should expect before, during, and after surgery
  • what your responsibilities will be before, during, and after surgery
You should have the opportunity to ask your doctor questions during this discussion.
Give yourself plenty of time to think about the risk/benefit discussion, to review any informational literature provided by your doctor, and to have any additional questions answered by your doctor before deciding to go through with surgery and before signing the informed consent form.

You should not feel pressured by your doctor, family, friends, or anyone else to make a decision about having surgery. Carefully consider the pros and cons.

The day before surgery, you should stop using:
  • creams
  • lotions
  • makeup
  • perfumes
These products as well as debris along the eyelashes may increase the risk of infection during and after surgery. Your doctor may ask you to scrub your eyelashes for a period of time before surgery to get rid of residues and debris along the lashes.

Also before surgery, arrange for transportation to and from your surgery and your first follow-up visit. On the day of surgery, your doctor may give you some medicine to make you relax. Because this medicine impairs your ability to drive and because your vision may be blurry, even if you don't drive make sure someone can bring you home after surgery.
What should I expect DURING surgery?
The surgery should take less than 30 minutes. You will lie on your back in a reclining chair in an exam room containing the laser system. The laser system includes a large machine with a microscope attached to it and a computer screen.

A numbing drop will be placed in your eye, the area around your eye will be cleaned, and an instrument called a lid speculum will be used to hold your eyelids open. A ring will be placed on your eye and very high pressures will be applied to create suction to the cornea. Your vision will dim while the suction ring is on and you may feel the pressure and experience some discomfort during this part of the procedure. The microkeratome, a cutting instrument, is attached to the suction ring. Your doctor will use the blade of the microkeratome to cut a flap in your cornea.

The microkeratome and the suction ring are then removed. You will be able to see, but you will experience fluctuating degrees of blurred vision during the rest of the procedure. The doctor will then lift the flap and fold it back on its hinge, and dry the exposed tissue.

The laser will be positioned over your eye and you will be asked to stare at a light. This is not the laser used to remove tissue from the cornea. This light is to help you keep your eye fixed on one spot once the laser comes on.

NOTE: If you cannot stare at a fixed object for at least 60 seconds, you may not be a good candidate for this surgery.

Good practices to follow before and after surgery

When your eye is in the correct position, your doctor will start the laser. At this point in the surgery, you may become aware of new sounds and smells. The pulse of the laser makes a ticking sound. As the laser removes corneal tissue, some people have reported a smell similar to burning hair. A computer controls the amount of laser energy delivered to your eye. Before the start of surgery, your doctor will have programmed the computer to vaporize a particular amount of tissue based on the measurements taken at your initial evaluation. After the pulses of laser energy vaporize the corneal tissue, the flap is put back into position.

A shield should be placed over your eye at the end of the procedure as protection, since no stitches are used to hold the flap in place. It is important for you to wear this shield to prevent you from rubbing your eye and putting pressure on your eye while you sleep, and to protect your eye from accidentally being hit or poked until the flap has healed.
What should I expect AFTER surgery?
Immediately after the procedure, your eye may burn, itch, or feel like there is something in it. You may experience some discomfort, or in some cases, mild pain and your doctor may suggest you take a mild pain reliever. Both your eyes may tear or water. Your vision will probably be hazy or blurry. You will instinctively want to rub your eye, but don't! Rubbing your eye could dislodge the flap, requiring further treatment. In addition, you may experience sensitivity to light, glare, starbursts or haloes around lights, or the whites of your eye may look red or bloodshot. These symptoms should improve considerably within the first few days after surgery.
You should plan on taking a few days off from work until these symptoms subside. You should contact your doctor immediately and not wait for your scheduled visit, if you experience severe pain, or if your vision or other symptoms get worse instead of better.

You should see your doctor within the first 24 to 48 hours after surgery and at regular intervals after that for at least the first six months. At the first postoperative visit, your doctor will remove the eye shield, test your vision, and examine your eye. Your doctor may give you one or more types of eye drops to take at home to help prevent infection and/or inflammation. You may also be advised to use artificial tears to help lubricate the eye. Do not resume wearing a contact lens in the operated eye, even if your vision is blurry.
What to expect after surgery

You should wait one to three days following surgery before beginning any non-contact sports, depending on the amount of activity required, how you feel, and your doctor's instructions.

To help prevent infection, you may need to wait for up to two weeks after surgery or until your doctor advises you otherwise before using lotions, creams, or make-up around the eye. Your doctor may advise you to continue scrubbing your eyelashes for a period of time after surgery. You should also avoid swimming and using hot tubs or whirlpools for 1-2 months.

Strenuous contact sports such as boxing, football, karate, etc. should not be attempted for at least four weeks after surgery. It is important to protect your eyes from anything that might get in them and from being hit or bumped.

During the first few months after surgery, your vision may fluctuate.
  • It may take up to three to six months for your vision to stabilize after surgery.
  • Glare, haloes, difficulty driving at night, and other visual symptoms may also persist during this stabilization period. If further correction or enhancement is necessary, you should wait until your eye measurements are consistent for two consecutive visits at least 3 months apart before re-operation.
  • It is important to realize that although distance vision may improve after re-operation, it is unlikely that other visual symptoms such as glare or haloes will improve.
  • It is also important to note that no laser company has presented enough evidence for the FDA to make conclusions about the safety or effectiveness of enhancement surgery.
Contact your eye doctor immediately, if you develop any new, unusual or worsening symptoms at any point after surgery. Such symptoms could signal a problem that, if not treated early enough, may lead to aloss of vision.
LASIK HOME What Is LASIK? Is It For Me? Risks And Finding a Doctor Checklist Glossary Resources


Source:  U.S. Food And Drug Administration   Center For Devices And Radiological Health

This site is not meant to replace the advice of a physician. You should not rely on any information on these pages, or information generated for you by this site, to replace consultations with qualified professionals regarding your own specific situation.
Copyright ® 2000-2007; Oleg Zhylko; All Rights Reserved.

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