I. General Information

The following information is intended to help you make an informed decision about having Laser Assisted In Situ keratomileusis (LASIK) surgery to correct your vision.

It is impossible to list all of the possible risks and complications associated with this proposed surgery or any other treatment. Risks and complications that are considered to be unforeseeable, remote, or commonly known are not discussed. In addition, because LASIK is a relatively recent surgery, there may be long-term effects not yet known or anticipated at the present time.

LASIK and Photorefractive Keratectomy (PRK) are both approved procedures by the U.S. Food and Drug Administration (FDA).

II. An Overview of the LASIK Procedure

Diagnosis: You have been diagnosed with myopia (near-sightedness), with or without astigmatism, or hyperopia (far-sightedness) with or without astigmatism.

LASIK Surgery Described: LASIK permanently changes the shape of the cornea. The surgery is performed using a topical anesthetic (drops in the eye). The procedure involves folding back a thin layer of corneal tissue (corneal flap) with a microkeratome (a surgical instrument much like a carpenter's plane). Once the flap has been made, a thin layer of corneal tissue is removed with the light from an excimer laser. After removal, the flap is replaced and bonds back into place, usually without the need for stitches. The removal of thin layers of tissue causes the center of the cornea to flatten in the case of nearsightedness, or become more rounded in the case of astigmatism, or steeper in the case of far-sightedness, which changes the focusing power of the cornea.

Limits of LASIK: Although the goal of LASIK is to improve vision to the point of not being dependent on glasses or contact lenses, or to the point of wearing thinner (weaker) glasses, this result is not guaranteed. Additional procedures, glasses, or contact lenses may be required to achieve adequate vision. LASIK does not correct the condition known as presbyopia (aging of the eye) which occurs in most people after age 40 and may require them to wear reading glasses for close-up work. If you presently need reading glasses, you will likely still need reading glasses after this treatment. If you do not need reading glasses, you may need them at a later age. LASIK surgery will not prevent you from developing naturally occurring eye problems such as glaucoma, cataracts, or retinal degeneration or detachment.

III. Risks and Contraindications:

The risks of LASIK surgery include, but are not limited to:

· Loss of Vision: LASIK surgery can possibly cause loss of vision or loss of best corrected vision. This can be due to infection (internal or external) or irregular scarring or other causes, and unless successfully controlled by antibiotics, steroids, or other necessary treatment, could even cause loss of the affected eye. Vision loss can be due to the cornea healing irregularly, which could add astigmatism and make wearing glasses or contact lenses necessary, or lead to loss of useful vision. Irregular cornea healing could result in a distorted corneal surface so that distorted vision or "ghosting" occurs. This may or may not be correctable by glasses or contact lenses.

· Visual Side Effects: Other complications and conditions that can occur with LASIK surgery include: anisometropia (difference in power between the two eyes); epithelial ingrowth (epithelial cells growing underneath the corneal flap); aniseikonia (difference in imaging size between the two eyes); double vision; hazy vision; fluctuating vision during the day and from day to day; increased or decreased sensitivity to light that may be incapacitating for some time and may not completely go away; glare and halos around lights, which may not completely go away .

· Overcorrection or Undercorrection: It may be that LASIK surgery will not give you the result you desired. Many procedures result in the eye being under corrected. If this occurs, it may be possible or necessary to have additional surgery to fine tune or enhance the initial result. It is also possible that your eye may be overcorrected to the point of becoming farsighted (by over treating myopia). It is possible that your initial results could regress over time. In some, but not all cases, re-treatment, glasses, or contact lenses could be effective in correcting vision.

· Other Risks: Other reported complications include: corneal ulcer formation; endothelial cell loss (loss of cell density in the inner layer of the cornea, possibly resulting in corneal swelling); ptosis (droopy eyelid); corneal swelling; contact lens intolerance; retinal detachment; hemorrhage. Complications could also arise requiring further corrective procedures including either a partial (lamellar) or full thickness corneal transplant using donor cornea. These complications include: loss of the corneal flap; damage to the corneal flap; flap decentration; progressive corneal thinning (ectasia). Sutures may also be required which could induce astigmatism. There are also potential complications due to anesthesia and medications that may involve other parts of your body. It is also possible that the microkeratome or the excimer laser could malfunction and the procedure stopped. Since it is impossible to state all potential risks of any surgery or procedure, this form does not provide a comprehensive listing of every conceivable problem.

· Later Discovered Complications: LASIK is a relatively recent technique. You should be aware that other complications may occur that have not yet been reported. Long term results may reveal additional risks and complications. After the procedure, you should continue to have routine check ups to assess the condition of your eyes.

· Difficulty in Determining Lens Implant Power after Cataract Surgery:  LASIK and PRK alter the relationship between the contour of the front surface of the cornea relative to the back surface.  Current technology for determining the power of lens implant used with cataract surgery is unreliable under these conditions.  Insertion of a lens implant in an eye that has previously undergone LASIK or PRK may result in unintended overcorrection or undercorrection, possibly requiring removal or replacement of the lens implant or other corrective procedures.

· Cost of Post Procedure Care: Costs for post procedure care, including corrective procedures and medications are not included in the costs of the LASIK procedure. Routine follow-up care related to the LASIK procedure is covered for a period of up to 6 (six) months.

· Risks of Not Undergoing LASIK: The risks of not having the surgery are limited to those associated with your current visual condition. These include but are not limited to the dangers that may be associated with losing glasses or contact lenses, the risks of corneal distortion and/or infection from wearing contact lenses, and the risks of trauma to the eye cause by breakage or plastic spectacles or contact lenses in the eye.

Contraindications: LASIK / PRK should not be performed on persons:

· with uncontrolled vascular disease; · with autoimmune disease; · who are immune compromised or on drugs or therapy that suppress the immune system; · with signs of keratoconus (steeping of the cornea); · with a previous history of keloid formation (large unsightly scars); · who are pregnant, nursing, or expecting to become pregnant within the six months following the LASIK procedure; · with residual, recurrent, or active ocular disease(s) or abnormality except for myopia in either eye; · with active or residual disease(s) likely to affect wound healing capability; · with severe nearsightedness, or astigmatism; · with unstable or uncontrolled diabetes; · with progressive myopia; · with amblyopia (lazy eye); or · with glaucoma.

If you know that you have any of these conditions, you should inform Dr. Pendleton. In addition, if you have any other concerns or possible conditions that might affect your decision to undertake LASIK surgery, you should discuss them with Dr. Pendleton.

IV. Alternatives to LASIK

LASIK is purely an elective procedure, and you may decide not to have this operation at all. Among the alternatives are:

· Eyeglasses / spectacles · Contact lenses · Photorefractive Keratectomy (PRK) · Radial Keratotomy (RK) · Automated lamellar keratoplasty (ALK) · Orthokeratology · Corneal relaxing incision

You should discuss these options with Dr. Pendleton.

V. Pre- and Post-Treatment Care

Before the LASIK Surgery

· Pregnancy. Pregnancy could adversely affect your treatment result since your refractive error can fluctuate during pregnancy. In addition, pregnancy may affect your healing process, and some medications may pose a risk to an unborn or nursing child.

If you are pregnant, or expecting to become pregnant, you should not undertake the LASIK procedure until after the pregnancy. If it is possible that you are pregnant, you should be tested so as to determine whether you are pregnant. If you become pregnant in the six (6) months following treatment, you should notify Dr. Pendleton immediately.

· Taking medications and allergies: You should inform Dr. Pendleton of any medications you may be taking, so as to account for the risk of allergic reactions, drug reactions, and other potential complications during the LASIK surgery and subsequent treatment.

· Contact lens wearers: Patients who wear gas-permeable or hard contact lenses must completely stop wearing such lenses at least one (1) month prior to the initial eligibility examination. (This period may be longer for some patients.) Patients who wear soft contact lenses must completely stop wearing their soft contact lenses at least two (2) weeks prior to the eligibility examination. Following the examination, if both you and your doctor agree that LASIK is the appropriate treatment, you must leave the contact lens out of the eye to be treated.

Post Treatment Precautions

· Eye Protection: Avoid exposing the eye to tap water in the bath or shower, as such non-sterile water may expose the eye to increased risks of infection. The eye shield should not be removed, nor should any eye drops be placed in the eye on the first day. Avoid rubbing the eye. The eye may be more fragile to trauma from impact. Evidence has shown that, as with any other scar, the corneal incision will not be as strong after healing as the original cornea was at the site of the incision. Therefore, the eye is somewhat more vulnerable to all varieties of injuries after LASIK, at least for the first year after surgery. It is advisable to wear protective eye wear when engaging in contact or racquet sports or other activities in which the possibility of a ball, projectile, elbow, fist, or other traumatizing object contacting the eye may be high.  If you routinely engage in these activities you should consider PRK as an alternative to LASIK.

· Operating Motor Vehicles: After surgery, you may experience starburst-like images or "halos" around lights, your depth perception may be slightly altered, and image sizes may appear slightly different. Some of these conditions may affect your ability to drive and judge distances. Driving should only be done when you are certain that your vision is adequate. On the day of the LASIK procedure, you should arrange to be driven home after the procedure.

· Pain and Discomfort: The amount of pain and discomfort that can be expected soon after the LASIK procedure varies with the individual. You should expect that the eye will be tender and sore to some extent after the surgery . Immediately after the procedure vision will be blurry, and you may experience some redness and/or corneal edema (swelling of the cornea). Some patients report the sensation of a foreign object in the eye.

VI. Patient Statement

· I have read this Informed Consent Form (or it has been read to me). The LASIK procedure has been explained to me in terms that I understand. · I have been informed about the possible benefits and possible complications, risks, consequences, and contraindications associated with LASIK. I understand that it is impossible for my doctor to inform me of every conceivable complication that may occur, and that because LASIK is a relatively recent procedure, there may be unforeseen risks. I have been given the opportunity to ask questions and have received satisfactory answers to any questions I have asked. I understand that no guarantee of a particular outcome was given and that my vision could become better or worse following treatment.

· My decision to undertake the LASIK procedure was made without duress of any kind. I understand that LASIK is an elective procedure, and my myopia, hyperopia, and/or astigmatism may be treated by alternative means, such as glasses, contact lenses, or other forms of refractive surgery. It is hoped that LASIK will reduce or possibly eliminate my dependency on glasses or contact lenses. I understand that the correction obtained may not be completely adequate and that additional correction with glasses or contact lenses or additional surgery may be needed.
 

· I consent to have LASIK performed on my right eye / left eye / both eyes (circle one).
 

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Robert B. Pendleton MD, PhD___________________________ Physician Name

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