Informed Consent for Refractive Surgery...

Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to undergo the contemplated procedure. The procedures used in obtaining informed consent should be designed to educate the patient in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the alternatives, risks, and benefits) must be written in "lay language", (i.e. understandable to the people being asked to participate). The consent document must be revised when deficiencies are noted or when additional information will improve the consent process.

There are many conditions known to negatively impact on the possible outcome from refractive surgery. At a minimum, you should have been screened, properly and thoroughly, for all of the below, prior to surgery. If you were not and, as a result, you have suffered a bad outcome, you may be able to sue your doctor for the suffering you experience. Presenting information in a general format (the same informed consent document being given to each patient), when patient-specific information is known, may well form the basis for a malpractice action. DO NOT BELIEVE THAT BECAUSE YOU HAVE SIGNED AN INFORMED CONSENT DOCUMENT THAT YOU DO NOT HAVE THE RIGHT TO SUE!

You should have been told, prior to surgery, that you were probably NOT a good candidate for refractive surgery if:
  • You are not a risk taker. Certain complications are unavoidable in a percentage of patients, and there are no long-term data available for current procedures.
  • It will jeopardize your career. Some jobs prohibit certain refractive procedures. Be sure to check with your employer, professional society, or military service before undergoing any procedure.
  • Cost is an issue. Most medical insurance will not pay for refractive surgery. Although the cost is coming down, it is still significant.
  • You required a change in your contact lens or glasses prescription in the past year. This is called refractive instability. Patients who are:
  • In their early 20s or younger, 
  • Whose hormones are fluctuating due to disease such as diabetes,
  • Who are pregnant or breastfeeding, or 
  • Who are taking medications such as steroids that cause fluctuations in vision, 

are more likely to have refractive instability and probably should not have a refractive procedure.

  • You have a disease or are on medications that may affect wound healing. Certain conditions, such as autoimmune diseases (e.g., lupus, rheumatoid arthritis), immunodeficiency states (e.g., HIV) and diabetes, and some medications (e.g., retinoic acid and steroids) may prevent proper healing after a refractive procedure.
  • You actively participate in contact sports. You participate in boxing, wrestling, martial arts or other activities in which blows to the face and eyes are a normal occurrence.
  • You are not an adult.  Currently, no lasers are approved for LASIK on persons under the age of 18.

Contraindications (Please note: the FDA has now changed these to "precautions" instead of :Contraindications as previously listed on their website. Do not allow the lobbying power of the refractive surgery industry to fool you into believing that they are not what they were previously called!)

The safety and effectiveness of refractive procedures has not been determined in patients with some diseases. Do NOT have LASIK surgery if you have a history of any of the following:

  • Herpes simplex or Herpes zoster (shingles) involving the eye area.
  • Glaucoma, glaucoma suspect, or ocular hypertension.
  • Eye diseases, such as uveitis/iritis (inflammations of the eye) and blepharitis (inflammation of the eyelids with crusting of the eyelashes). 
  • Eye injuries or previous eye surgeries.
  • Keratoconus

Other Risk Factors
Your doctor should screen you for the following conditions or indicators of risk:

  • Large pupils. Make sure this evaluation is done in a dark room. Younger patients and patients on certain medications may be prone to having large pupils under dim lighting conditions. This can cause symptoms such as glare, halos, starbursts, and ghost images (double vision) after surgery. In some patients these symptoms may be debilitating. For example, a patient may no longer be able to drive a car at night or in certain weather conditions, such as fog.
  • Thin Corneas. The cornea is the thin clear covering of the eye that is over the iris, the colored part of the eye. Most refractive procedures change the eye’s focusing power by reshaping the cornea (for example, by removing tissue).  Performing a refractive procedure on a cornea that is too thin may result in blinding complications.
  • Previous refractive surgery (e.g., RK, PRK, LASIK).  Additional refractive surgery may not be recommended.  The decision to have additional refractive surgery must be made in consultation with your doctor after careful consideration of your unique situation.
  • Dry Eyes. LASIK surgery tends to aggravate this condition.

Gray & Black LARGE REFRACTIVE ERROR (ANY TYPE) OR SMALL AMOUNTS OF ASTIGMATISM - Results are generally not as good in patients with very small amounts of astigmatism or 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. (FDA warning 7/01). You should have been told that glasses and/or contact lenses may not be able to correct vision problems which can exist following laser surgery.

Gray & Black PREVIOUS REFRACTIVE SURGERY (e.g. RK, PRK, LASIK).  Additional refractive surgery may not be recommended.  The decision to have additional refractive surgery must be made in consultation with your doctor after careful consideration of your unique situation. (FDA warning 4-01). This can have significant impact on "enhancements", the follow up surgery performed after the initial laser surgery has failed to deliver acceptable results.  

Gray & Black AGE: It is required by the FDA that a person undergoing LASIK must be at least eighteen years old. It is, however, noted by them that patients who are in their early 20s or younger  are more likely to have refractive instability and probably should not have a refractive procedure. Also, since this procedure is essentially elective surgery, attainment of legal age is appropriate in order to provide fully informed consent. There is no established upper age limit for laser surgery eligibility but age may effect the healing process and the outcome of the surgery.

Gray & Black HORMONAL FLUCTUATIONS: Hormonal fluctuations can effect the shape and refractive error of a person's eye. Surgery during a period of such instability may lead to unpredictable results. Therefore, the procedure is not recommended for women who may be pregnant, nursing, or undergoing changes in oral contraceptive therapy.

Gray & Black HEALTH: The cornea is composed of a matrix of collagen fibers, the same material which comprises tendons and other connective tissue. Therefore, persons who have autoimmune disorders, e.g., rheumatoid arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosis, etc., may be at risk for healing problems and unpredictable refractive changes following surgery. 

Gray & Black EMPLOYMENT CONSIDERATIONS: You must determine if having refractive surgery (no matter what the outcome) will jeopardize your career. Some jobs prohibit certain refractive procedures. Be sure to check with your employer/professional society/military service  (see section for Military/Pilots) before undergoing any procedure.

Gray & Black PSYCHOLOGICAL ISSUES: Awareness and acceptance of less than a 'perfect' result is essential prior to undergoing surgery. You may be under corrected or over corrected. There is no guarantee that the operation will meet a patient's expectations. A prospective patient will expect that LASIK will substantially improve the uncorrected visual acuity but must be able to cope with the possible complications and be willing to accept that glasses or contact lenses may still be necessary for some activities. Only a certain percent of patients achieve 20/20 vision following surgery. You may require additional treatment, but additional treatment may not be possible. You may still need glasses or contact lenses after surgery (but it may not be possible to adequately correct the results of laser surgery with either glasses or contact lenses). This may be true even if you only required a very weak prescription before surgery. If you used reading glasses before surgery, you will still need reading glasses after surgery. (FDA warning 7/01). You should be told that the mere achievement of 20/20 vision in a Snellen chart in a doctors office does not mean your surgery was a success or that you will be happy with the results achieved. Beware the surgeon who stresses the percentage of his patients who have achieved a given degree of visual acuity with giving equal time to complication which can exist event where such acuity has been achieved. 

Gray & Black PUPIL SIZE: Most Excimer lasers in the United States currently treat an area of the cornea that measures 6 - 7 mm in diameter. Therefore, it is important that the pupil size be no larger than the area of treatment. Measurement of the pupil size should be performed with distance fixation in dim illumination. It should not be estimated by your doctor or measured by holding a calibrated card up to your eye. Much of the reported difficulties with glare experienced by LASIK patients come from those with pupil size irregularities. 

Gray & Black CORNEAL THICKNESS:  It is currently believed that a 250 micron residual amount of corneal tissue should remain following surgery. It follows, necessarily, that your corneal thickness must be measured, pre-operatively, and you must be advised of the accepted standard and the corneal thickness you will be left with after surgery.  

Gray & Black DEGREE OF REFRACTIVE ERROR:  Results are generally not as good in patients with very large refractive errors of any type. A surgeon should specifically discuss the risk of a poor outcome with any patient  with large refractive error. Merely handing you an Informed Consent document without advising how it applies to you is not sufficient.

Most persons are either nearsighted or farsighted with some degree of astigmatism. After the age of about 42, people also experienced difficulties with focusing at near – this is known as presbyopia. LASIK does not correct presbyopia. Reading glasses will be needed by older patients following surgery.

The range of refractive errors which can currently be treated are:

Myopia (nearsightedness) : -0.75 diopters to -14.0 diopters. Dependant upon laser used. Myopics of -10 diopters or greater are at increased risk of experiencing a poor outcome (there are those who believe -7 diopters is the beginning of the zone of increased risk). They should be so advised and a responsible surgeon may well recommend against surgery.

Hyperopia (farsightedness) : +0.75 diopters to +6.0 diopters. Dependant upon laser used

Astigmatism (associated with myopia) : 0 to 5.0 diopters. Dependant upon laser used

Astigmatism (associated with hyperopia) : 0 to 5.0 diopters. Dependant upon laser used

Presbyopia  No treatment (currently in development with mixed results). Some doctors involved in testing also have a financial stake in the corporation that developed the surgery and sells devices to perform it, raising questions about their objectivity Not FDA approved.) 

Gray & Black REFRACTIVE INSTABILITY: You required a change in your contact lens or glasses prescription in the past year. This is called refractive instability. 

Gray & Black PREGNANCY: You should understand that pregnancy causes fluctuations in hormones which, in turn, can cause fluctuations in vision  

Gray & Black FOR ALL PATIENTS:  Other medical conditions  will unnecessarily expose you to risks of complications following surgery:

    Unstable or uncontrolled diabetes 

    Significant  lagophthalmos - a condition in which complete closure of the eyelids over the eyeball is difficult or impossible.

    Severe dry eye, blepharitis, or severe inflammation of the eyelid margins.

    Uncontrolled uveitis, or chronic inflammation inside the eye.

    Vascular disease 

    Autoimmune disease or immunocompromised or on drug therapy suppressing the immune system

   Keratoconus (patients with this condition may have unstable corneas) 

    History of keloid formation (unpredictable corneal healing response) 

    Herpes Simplex or Herpes Zoster Virus A history of herpes simplex infection of the eye may be a contraindication to LASIK surgery. It is believed that the virus may permanently reside in nerve cells outside the eye and that any trauma (such as LASIK) might reactivate an infection. However, the relationship between prior herpes infection and refractive surgery is currently being re-evaluated. Studies are being done to see if treatment with antiviral medication prior and after the operation might prevent such a recurrence. 

    Residual, recurrent or active ocular disease(s) or abnormality except for myopia or hyperopia in either eye 

    Active or residual disease(s) likely to affect wound-healing capability 

    Progressive myopia or hyperopia 

    Amblyopia (lazy eye) 

    Glaucoma; or 

    Presence of a pacemaker, insulin implant or other implanted electronic device in the patient

Gray & Black CONTACT LENS WEAR: You should have been told to discontinue the use of your contact lenses prior to your exam and prior to the surgery.  Please note the following:

Hard Contacts/Rigid Gas Permeable
At least three weeks minimum prior to exam and surgery.

Soft Contacts
At least for three days prior to your exam.

The "Informed Consent" document, which should be signed by all patients prior to surgery, must fully discuss all known complications and contraindications. There are many conditions which can be identified by pre-operative testing that would eliminate a patient as a reasonable candidate for surgery (thereby avoiding a bad outcome for the patient and potential malpractice litigation for the surgeon). All of the known contraindications, listed below, as well as all known potential complications, generally and as they specifically apply to each individual patient, should have been made known to the patient before surgery.   DO NOT BELIEVE THAT BECAUSE YOU HAVE SIGNED AN INFORMED CONSENT DOCUMENT THAT YOU CANNOT SUE. THIS, SIMPLY, ISN'T THE CASE.