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.
The first refractive laser systems approved by FDA were excimer lasers for use in PRK to treat myopia and later to treat astigmatism. However, doctors began using these lasers for LASIK (not just PRK), and to treat other refractive errors (not just myopia). Over the last several years, LASIK has become the main surgery doctors use to treat myopia in the United States. More recently, some laser manufacturers have gained FDA approval for laser systems for LASIK to treat myopia, hyperopia and astigmatism and for PRK to treat hyperopia and astigmatism.(22 June 2009 - Online press Dr. Boothe )
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 mechanical microkeratome (a blade device) or a laser keratome (a laser device) 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.
Pupil- The pupil is the dark opening in the visible eye. It will open when more light is needed to see, and it will get smaller if less light is needed to see.
Astigmatism:
Astigmatism causes a distortion of vision, where a person may experience an overall blurriness. Information regarding an astigmatism is found in the cylinder column. Many people with myopia or hyperopia have some degree of astigmatism
Presbyopia:
LASIK surgeons cannot correct this age-related vision problem; it occurs in most individuals starting in the early 40s and progresses with age.
Muscles inside the eye lose flexibility and reading can become difficult.
People may have presbyopia in combination with another vision problem like nearsightedness.
The nearsightedness would be correctable by LASIK surgery, but the presbyopia would not; however, we may be able to find an adjustment to compensate for both.Dr. Boothe Laser Center
What the FDA regulates
In the United States, the Food and Drug Administration (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 "indication." Once the FDA has approved a medical device, a doctor may decide to use that device for other indications if the doctor feels it is in the best interest of a patient. The use of an approved device for other than its FDA-approved indication is called "off-label use." The FDA does not regulate off-label use or the practice of medicine.
Corneal Epithelium- The corneal epithelium is the thin, protective layer encasing the eyeball. Prior to LASIK eye surgery, the epithelium must be lifted or polished away to expose the underlying cornea. The epithelium is regenerative and heals quickly. (26 January 2008 Dr. Boothe Eye Care )
Boothe Laser Center article
LASIK- LASIK is an acronym that allows us to quickly say, "laser assisted in situ keratomileusis." This is more simply said as "reshaping the cornea using a laser."
Hyperopia or Hypermetropia- Many Hyperopic patients have difficulty seeing things up close, and often have crisp-acute distance vision.( 24 October 2007 Blog article Dr. Boothe Laser Center )
