Lasik informed consent

INFORMED CONSENT FOR LASER IN-SITU KERATOMILEUSIS (LASIK) FOR
THE CORRECTION OF MYOPIA (NEARSIGHTEDNESS), FARSIGHTEDNESS
(HYPEROPIA), ASTIGMATISM, OR MIXED ASTIGMATISM
Introduction
This information is being provided to you so that you can make an informed decision about the use of a device known as a microkeratome, combined with the use of a device known as an excimer laser, to reshape the eyeto reduce or eliminate refractive errors. LASIK is an elective procedure. There is no emergency condition or otherreason that requires or demands that you have it performed. You could continue wearing contact lenses or glassesand have adequate visual acuity.
This procedure, like al surgery, presents some risks, many of which are listed below. The first important message to understand is that it is impossible to perform any type of surgery without the patient accepting a certaindegree of risk and responsibility. You should also understand that there might be other risks not known to your doctor,which may become known later. Despite the best care, complications and side effects may occur. Should this happenin your case, the result might make your vision worse.
Despite al our efforts, if a complication occurs, patients sometimes feel they did not ful y comprehend the risks outlined. For this reason we have put together this consent form. Many of our patients are surprised and someare upset by the extent to which we attempt to inform them of the potential for complications. It is not our intention tofrighten or dissuade someone from pursuing LASIK laser surgery, as most of our patients wil never encounter anycomplications, and the vast majority are pleased with the improvement they achieve. It is our intention, however, toaccurately outline the associated risks to al candidates so that they may either elect not to accept the associated risksby declining surgery or be better prepared to deal with any unexpected complications or side effects. The only way inwhich a patient can avoid al surgical risks is by not proceeding with the surgery. No surgery is always 100%successful or 100% risk free.
PATIENT CONSENT
In giving my permission for the use of the microkeratome and an excimer laser for LASIK, I have received no disclaimers from any person, advertisement, or other educational materials that are contrary to this document andhave received no guarantee as to my final outcome. I understand the fol owing about this procedure: Alternatives to LASIK
I understand that if I decide not to have LASIK, there are other methods of correcting my refractive error.
These alternatives include, among others, eyeglasses, contact lenses, Photorefractive Keratectomy (PRK), RadialKeratotomy (RK), Corneal Rings, clear lensectomy, laser thermokeratoplasty, phakic implant lenses (Visian), orwaiting for future improvements or new technology.
Contraindications, Warnings, and Precautions to LASIK
CONTRAINDICATIONS: I understand that LASIK surgery is contraindicated in patients who: are pregnant or
nursing; show signs of keratoconus; are taking the medications isotretinoin (Accutane®) or amiodarone hydrochloride(Cordarone®); or have an autoimmune disease, col agen vascular disease (Rheumatoid arthritis, lupus, Wegener’s,others), or an immunodeficiency disease.
WARNINGS: LASIK is not recommended in patients who have: insulin-dependent diabetes; severe al ergies;
a history of herpes simplex or herpes zoster keratitis; a history of infectious diseases (HIV, hepatitis, TB, others);severe dry eyes; cataracts or other significant eye disease; or who have a prescription that is changing a lot.
PRECAUTIONS: The safety and effectiveness of LASIK has not been established: in patients with:
progressive myopia; ocular disease; corneal abnormality; previous corneal or intraocular surgery; trauma in theablation zone; history of glaucoma; or history of keloid formation (excessive scarring); patients who are taking themedication Sumatripin (Imitrex®); in patients under 21 years of age; patients with implant lenses after cataractsurgery; individuals suffering from significant depression or anxiety disorders; or patients with exceptional y highprescriptions or low prescriptions.
I understand that I should notify my ophthalmologist if any of these apply to me, and that if I elect to proceed with LASIK surgery after discussion with my ophthalmologist that there may be extra risks involved, understand thatthe accuracy and final outcome may not be as good, and understand that there may be unknown risks or side effectsthat have not been adequately studied.
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Vision Threatening Complications
1. I understand that the microkeratome or the excimer laser could malfunction, requiring the procedure to be
stopped before completion. Depending on the type of malfunction, this may or may not be accompanied by somedecrease in vision.
2. I understand that, in using the microkeratome, instead of making a flap, an entire portion of the central cornea could be cut off, and very rarely could be lost. If preserved, I understand that my doctor would put this tissue backon the eye after the laser treatment and may require using sutures. It is also possible that the flap incision couldresult in an incomplete flap, or a flap that is too thin. If this happens, it is likely that the laser part of the procedurewil have to be postponed until the cornea has a chance to heal sufficiently to try to create the flap again or toperform PRK instead of LASIK.
3. I understand that irregular healing of the flap could result in a distorted cornea. This would mean that glasses or contact lenses may not correct my vision to the level possible before undergoing LASIK. If this distortion in visionis severe, a partial or complete corneal transplant might be necessary to repair the cornea.
4. I understand that the epithelium or surface skin of one or both eyes can loosen during surgery and this may delay my healing, heal irregularly, or heal inappropriately (grow under the flap). In some cases my eyes may not healwel causing blurred vision that glasses or contact lenses may not correct. This may necessitate having furtherprocedures or wearing special contact lenses, may prevent safe treatment of the other eye, or prevent havinglater enhancement surgery.
5. I understand that a possible perforation of the cornea could occur, causing significant complications, including loss of some or al of my vision. Severe problems can also be caused by an internal or external eye infection(corneal ulcers) that might not be control ed with antibiotics or other means, or by severe inflammation (diffuselamel ar keratitis or corneal “melting”) that might not be control ed with eyedrops or other means. I understand thatother very rare complications threatening vision include, but are not limited to: corneal swel ing, corneal “melting”,retinal detachment, hemorrhage, venous and arterial blockage, cataract formation, total blindness and even lossof my eye.
6. I understand that further eye problems related or unrelated to the surgery may arise at a later date including but not limited to: keratoconus (irregular cornea), cataracts, retinal detachments or hemorrhages, glaucoma, epithelialingrowth (flap problem), irregular or loose epithelium or severe dry eyes.
Non-Vision Threatening Side Effects and General Information
1. I understand that each person responds and heals after LASIK somewhat differently. I understand that because
of this unpredictable variability, no guarantees as to my final vision or speed of recovery can be given. Iunderstand that I may have a slower recovery with blurred vision or need additional treatments or visits at a latertime. This can require more time off work, may cause delay in other plans, and can cause emotional stress.
2. I understand that at night there may be a "starbursting" or halo effect around lights. I understand that this condition is common right after surgery and usual y diminishes with time, but could be permanent. I understandthat my vision may not seem as sharp at night as during the day and that I may need to wear glasses at night. Iunderstand that I should not drive until my vision is adequate both during the day and at night. I understand thatconditions that increase the likelihood of night vision problems include, but are not limited to: large pupils, ageless than 30, high prescriptions, high astigmatism, thin corneas, or occupations requiring a lot of night driving.
3. I understand that my eyes may be drier than usual after surgery causing some discomfort and blurred vision and requiring the use of moisturizing eye drops. I understand that this condition is common right after surgery andusual y diminishes with time, but could be permanent. I understand that conditions that increase the likelihood ofdry eye problems include, but are not limited to: prior problems with dry eyes, arthritis, being post-menopausal,age greater than 50 years old, medications that dry the eyes, thyroid related eye problems, or doing a lot of nearwork or computer work.
4. I understand that some occupations (e.g. pilots, police officers, military occupations, etc.) may require a certain level of vision for that occupation, and that refractive surgery may not offer that level of vision, and/or thatrefractive surgery may limit qualifying for some occupations. Guidelines change frequently, and you should checkyour particular situation before proceeding.
5. I understand that if I am prone to depression/anxiety, or I am prone to difficulties handling and adapting to stress, or I am very critical of my vision, that I am more likely to experience visual and emotional problems adapting to aslow recovery, visual side effects, or unexpected complications. I understand that if I am taking anti-depressantsor anti-anxiety agents that I am more likely to experience dryness, fluctuating vision, and focusing difficultiespossibly as a side effect of the medications. I understand that some people should elect not to pursue LASIKsurgery if they feel they are at risk for handling the added stress.
6. For nearsightedness w/wo astigmatism: I understand that if my nearsightedness is greater than 7 diopters, or
my astigmatism is greater than 2 diopters, or if my age is greater than 45 that my recovery wil be longer, the
ultimate accuracy may not be as good, and I am more likely to require second treatments (enhancements).
For farsightedness w/wo astigmatism & mixed astigmatism: I understand that if my farsightedness is greater
than 4 diopters, or my astigmatism is greater than 2 diopters, or if my age is greater than 45 that my recovery wil
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be longer, the ultimate accuracy may not be as good, and I am more likely to require second treatments(enhancements). I understand that for al levels of farsightedness the recovery period is substantial y longer, andthe final clarity often not quite as good as that for equivalent amounts of nearsightedness.
7. I understand that there may be increased sensitivity to light, glare, halos, a difference in the size of images (aniseikonia), and fluctuations in the sharpness of vision. I understand these conditions usual y occur during thenormal stabilization period from one to three months, but they may also be permanent.
8. I understand that an overcorrection or undercorrection could occur causing me to be nearsighted, farsighted, or to have astigmatism (even if I didn’t have any before). This could be either permanent or treatable. I understand thatovercorrections and undercorrections are more likely in people over the age of 40 years and may require the useof glasses or contacts for reading, intermediate, or for distance vision some or al of the time.
9. I understand that I may not get a ful correction from my LASIK procedure and this may require future enhancement procedures, other surgeries, or the use of glasses or contact lenses. I understand that I may not beable to achieve a ful correction even with further enhancement procedures.
10. I understand that there may be a "balance" problem between my two eyes after LASIK has been performed on one eye, but not the other. I understand this could cause eyestrain and make judging distance or depth perceptionmore difficult and may require the use of contact lenses.
11. I understand that, after LASIK, the eye may be more fragile to trauma from impact. Evidence has shown that, as with any surgery, the cornea may not be as strong as the cornea original y was. I understand that the treated eye,therefore, is somewhat more vulnerable to al varieties of injuries, at least for the first year fol owing LASIK. Iunderstand it would be advisable for me to wear protective eyewear when engaging in sports or other activities inwhich the possibility of a bal , projectile, elbow, fist or other traumatizing object contacting the eye may be high.
12. I understand that there is a natural tendency of the eyelids to droop with age and that eye surgery may hasten 13. I understand that cataracts (clouding of the lens of the eye) occur in most people as they get older, and that my eyes wil change with the formation of cataracts, affecting some of the benefit of my LASIK surgery. This maycause my vision to change, requiring a return to lens wear, and usual y requires surgical correction at some point.
I understand that I should tel my cataract surgeon that I have had LASIK surgery done, as the power of myimplant lens used with cataract surgery wil need to be modified.
14. I understand that there may be pain or a foreign body sensation, particularly during the first 48 hours after 15. I understand that temporary glasses either for distance or reading may be necessary while healing occurs and that more than one pair of glasses may be needed.
16. I understand that the long term effects of LASIK are not known, and that unforeseen complications or side effects could occur. LASIK has been studied for more than ten years.
17. I understand that visual acuity I initial y gain from LASIK could regress, and that my vision may go partial y or completely back to the level it was immediately prior to having the procedure.
18. I understand that the correction which I can expect to gain from LASIK may not be perfect. I understand that it is not realistic to expect that this procedure wil result in perfect vision, at al times, under al circumstances, for therest of my life. I understand I may need glasses or contacts to refine my vision at some point later my life, and thatthis might occur soon after surgery or years later. I understand that nearly everyone needs reading glasses as wegrow older.
19. I understand that I wil be given medication (eye drops) in conjunction with the procedure and that my eye may be patched afterward. I understand that using these medications and fol owing al directions are vital to achieving agood outcome. I understand that I must not drive for at least one day fol owing the procedure and not until I amcertain that my vision is adequate for driving. I understand that there may be other activity restrictions as wel .
20. I understand that if I currently need reading glasses or are more than 40 years old, I wil likely need reading glasses after this treatment. I understand that if I am used to taking my glasses off for reading or intermediatedistance, this wil not be possible after my surgery. It is possible that dependence on reading glasses mayincrease or that reading glasses may be required at an earlier age if I have this surgery. If I am more than 40, Iunderstand that I may choose to have monovision done (one eye left near-sighted for upclose) and havediscussed this with my ophthalmologist.
21. I understand that some uses of equipment may not have been ful y considered or evaluated by the FDA. These are known as off label uses. Advances sometimes outpace the FDA process and studies sometimes haveinsufficient numbers to adequately evaluate some options. Examples of this may include: treating larger zones(areas); treating higher ranges of prescription and astigmatism; treating very low ranges of prescriptions; treatingpatients less than 21 years old; treating patients with lesser contraindications, warnings, or precautions; or othersnot listed here.
22. Even 90% clarity of vision is stil slightly blurry. Enhancement surgeries can be performed when vision is stable UNLESS it is unwise or unsafe. Typical y, if 1.00 diopter or greater correction remains or vision is 20/40 or worse,an enhancement may be performed. If the enhancement is performed within the first six months fol owing surgery,there general y is no need to make another cut with the microkeratome. The original flap can usual y be lifted with Please initial here to signify that you have read this page____________
specialized techniques. After 6 months of healing, a new LASIK incision may be required, incurring greater risk. Inorder to perform an enhancement surgery, there must be adequate tissue remaining. If there is inadequate tissue,it may not be possible to perform an enhancement. An assessment and consultation wil be held with the surgeonat which time the benefits and risks of an enhancement surgery wil be discussed.
23. I understand that, as with al types of surgery, there is a possibility of complications due to anesthesia, drug reactions or other factors that may involve other parts of my body. I understand that, since it is impossible to stateevery complication that may occur as a result of any surgery, the list of complications in this form may not becomplete.
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CONSENT FOR BILATERAL SIMULTANEOUS LASIK
Introduction
If you elect to have surgery performed on both eyes at the same time, you should understand both the possible advantages and disadvantages of your decision.
The advantages of having LASIK performed on each eye at a separate time are:
 Safety: You wil not experience the risk of developing an infection or other severe complication in both eyes at the
same time, which although very rare, could lead to significant decrease in vision in both eyes. Should this occur inboth eyes at the same time, carrying out normal activities could be difficult.
 Accuracy: The doctor can monitor the healing process and visual recovery in the first eye and may be able to
make appropriate modifications to the treatment plan for the second eye, increasing the likelihood of a betteroutcome in the second eye.
 Visual Recovery: Although most LASIK patients experience a rapid recovery in their vision, the recovery can at
times be delayed. If the eyes are operated on separately, you can function with the fel ow eye while the first eyeful y recovers. This is especial y true if you are able to wear a contact lens in the unoperated eye.
 Satisfaction: You wil be given the opportunity to determine whether the LASIK procedure has produced
satisfactory visual results without loss of vision or other uncommon undesirable side effects such as glare, ghostimages or increased light sensitivity. If you are over age 40, you wil have an opportunity to experience thechange in your close vision resulting from the correction of your nearsightedness. This could influence yourdecision whether to ful y correct your other eye to maintain some degree of close vision without the need forglasses (monovision).
The disadvantages of having LASIK performed on each eye at a separate time are:
 Convenience: It may be inconvenient for you to have each eye treated at separate visits. This wil necessitate
two periods of recovery from the laser surgery and may require additional time away from work.
 Visual Recovery: There wil be a potential period of imbalance in vision between your two eyes. This is
especial y important if you are unable to wear a contact lens in your unoperated eye. It is not usual y possible touse the operated eye without a corrective lens along with a strong corrective lens in the unoperated eye becauseit produces a strong sense of imbalance, dizziness and a form of double vision.
The advantages of having LASIK performed on both eyes at the same time are:
 Convenience: It may be more convenient to have both eyes treated during the same visit and you may be able to
 Visual Recovery: The balance in vision between your two eyes wil usual y be restored more rapidly. This is
especial y true if you are unable to wear a contact lens in your unoperated eye.
The risks of having LASIK performed on both eyes at the same time are:
 Safety: The risk of infection, delayed clouding of the cornea, corneal scarring and internal bleeding or retinal
damage is very rare but potential y devastating. If these serious but rare complications occur in one eye, they mayalso occur in the other. Should any of these complications happen, you could experience significant loss decreasein vision or even temporary or permanent legal blindness.
 Accuracy: By correcting both eyes simultaneously, there is no opportunity to learn from the healing patterns of
the first eye before treating the second eye. Therefore, if there is an over-correction or under-correction in oneeye, chances are it wil happen in both eyes. If a retreatment is required in one eye, it is quite possible that yourfel ow eye also wil require a retreatment.
 Visual Recovery: LASIK patients general y experience rapid visual recovery. Some patients, however,
experience delayed visual recovery and symptoms such as blurred vision, night glare or ghost images. There isno way to predict how long your eyes wil take to heal, and some of these side effects can result in prolongedrecovery of normal vision. Blurred vision may rarely continue for several weeks in both eyes, which could makedriving difficult or dangerous and could interfere with your ability to work. The healing corneal flap is mostsusceptible to trauma during the first several weeks after surgery. Should both flaps become accidental ydisplaced, significant decrease in vision in both eyes may result.
 Satisfaction: Both eyes tend to experience similar side effects. If you experience undesirable side effects such
as glare, ghost images, increased light sensitivity or corneal haze in one eye, you wil likely experience them inboth eyes. These side effects may cause a decrease in vision or other negative effects, and some patients haveelected to not have their second eye treated, or to wait until the side effects lessen or resolve.
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Implied Consent for Special Circumstances
I understand that special circumstances may arise where I give my implied consent for my surgeon to act in my best interest. I understand that I wil be only minimal y sedated, and my ophthalmologist wil attempt to explainand discuss any special circumstances with me as the situation al ows, and nothing wil be done against myobjections. Examples of special circumstances include: A minor problem with one eye (examples include looseepithelium or other flap problems) may require judgement on whether to proceed with the second eye that day orpostpone treatment. It may not be possible or safe to create a flap for LASIK (examples include inability to fit thesuction ring, epithelial problems, or others) and you may want to consider having PRK (laser vision correction done byremoving the epithelium instead of creating a flap) done that day instead. An unexpected problem may need otherprocedures done immediately for repair (for example suturing, others). Other circumstances not listed here might alsoarise.
Care Commitment, Financial Consent, & Comanagement Option
I understand that my fees for surgery include my pre-operative exam, measurements of my eye(s) and reporting done for outcome analysis, my surgery, and my post-operative exams with my co-managing doctor (if any)or us for one year from the date of your surgery. Additional y, any LASIK enhancements I may need within the firstyear wil be done at no additional charge.
Items NOT covered in my fees include, but are not limited to: prescription medications, artificial tear drops,
material costs for glasses or contact lenses, fees for second opinions or surgeries, extra fees for wavefronttreatments, fees for other surgeries other than LASIK enhancements within the first year, travel expenses, missedwork expenses, and any other expenses not specifical y included above.
I may optional y choose, by initialing here, to have some part of my post-operative care done with my own eye doctor if it is more convenient for me (e.g. travel, office hours, and familiarity). My LASIK surgeon wil perform mysurgery and see me the first few visits, afterwards I can see my own optometrist/ophthalmologist for some of the post-operative visits. There is NO extra charge to do this, and payment can be forwarded directly to your ownoptometrist/ophthalmologist by our office by giving your permission here. I give my permission to forward medical andhealth information to my comanaging doctor. Even though my other eye doctor may provide some of my post-operative care, I understand that my LASIK surgeon wil continue to be available to me if I should develop acomplication or have any questions about my care. I understand that my LASIK surgeon cannot, however, assumeany risk or liability involved in my choosing to see my own eye doctor for some portion of my post-operative care.
I elect to see Dr. ________________________ for part of my post-operative care.
I elect to see only my surgeon and his staff for my post-operative care.
(initial one)
PATIENT’S STATEMENT OF ACCEPTANCE AND UNDERSTANDING
The details of the procedure known as LASIK have been presented to me in detail in this document, explained to me by my ophthalmologist, and I have reviewed the advantages, disadvantages, possible risks, andalternatives at my leisure. Although it is impossible for the doctor to inform me of every possible complication that mayoccur, my ophthalmologist has answered al my questions to my satisfaction. I have received no disclaimers from anyperson, advertisement, or other educational materials that are contrary to this document and have received noguarantee as to my final outcome. I therefore consent to LASIK surgery. I give permission for my ophthalmologist torecord my procedure and use data about my procedure for purposes of education, research or training of other healthcare professionals. I understand that my name wil remain confidential, unless I give subsequent written permissionfor it to be disclosed outside my ophthalmologist’s office or the office where my LASIK procedure wil be performed. Insigning this document, I do so knowingly, voluntarily and intel igently.
Patient signature__________________________________ Date________________
Witness signature_________________________________ Date________________
( the patient has confirmed to me that they have read and understand this consent )
I have been offered a copy of this consent form (patient initials) ________
Please initial here to signify that you have read this page____________

Source: http://www.stahlvision.com/lasik-surgery-forms/informedconsentlasik.pdf