TLC Vision Home
Informed Consent
for Primary Custom LASIK

Please read the following pages carefully and initial and sign where indicated. Please do not sign any section that you have not read or do not understand. It is important that you bring this informed consent with you on the day of your procedure.

SECTION 1: GENERAL INFORMATION ON INFORMED CONSENT
It is our hope to fully inform you concerning the side effects, limitations and complications of Custom LASIK surgery. We continually struggle to balance the benefits of laser surgery with the known and unknown risks. It is important to understand that it is impossible to perform any form of surgery without the patient accepting a certain degree of risk and responsibility. This consent form, in combination with the extensive educational materials provided and the entire consultation process, is designed to enhance your understanding of the potential for difficulties that may be encountered during both the procedure and the healing process.

Many of our patients are surprised and some are upset by the extent to which we attempt to inform them of the potential for complications. It is not our intention to frighten or dissuade someone from pursuing laser surgery, as most of our patients will never encounter any serious complications and the vast majority are pleased with the improvement they achieve. It is our intention, however, to accurately outline the associated risks to all candidates so that they may either elect not to accept the risks associated or be better prepared to deal with any unexpected complication or side effects which may arise. Custom LASIK is a purely elective procedure, and you may decide not to have this operation at all. The only way to avoid all surgical risk is by not proceeding with surgery.

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SECTION 2: LASER VISION CORRECTION BACKGROUND SUMMARY

Laser in situ Keratomileusis (LASIK), a form of laser vision correction, reshapes the part of the eye known as the cornea to possibly reduce or eliminate the need for glasses or contact lenses in cases of myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (ovalness). There are two primary techniques for reshaping the cornea with laser surgery, PRK and LASIK. In both forms of laser vision correction, the transparent cornea at the front of the eye is reshaped with your prescription. PRK, or photorefractive keratectomy, reshapes the surface layers of the cornea, while Custom LASIK fine tunes the inner corneal layers with the Excimer laser. The Excimer laser produces a cool beam of ultraviolet light energy, capable of removing very precise amounts of corneal tissue to change the shape or curvature of the cornea and potentially improve your vision. The LASIK procedure is a newer, more advanced form of keratomileusis, a procedure that has been practiced in South America and Europe for over three decades. Both procedures are able to treat myopia, hyperopia and astigmatism but have benefits, limitations and risks.

Both PRK and Custom LASIK are performed on an outpatient basis and take only 5 to 15 minutes to complete. Although patients often feel some pressure sensation, both procedures are painless. In both the PRK and Custom LASIK procedures, topical anesthetic drops are used to thoroughly numb the eye, and an eyelid holder is used to prevent blinking. Patients focus on a red target light throughout both procedures. In the PRK procedure, the surgeon first removes the corneal epithelium, or protective surface layer of the cornea. The Excimer laser then applies computer-controlled pulses of light energy to the corneal surface to reshape the eye. Following PRK, typically a bandage contact lens is inserted, or the surgeon may patch the eye closed for a few days. The epithelium grows back over 3 or 4 days and the vision gradually improves once the protective layer is healed. In the Custom LASIK procedure, a protective corneal flap is created using a very sophisticated surgical instrument known as a microkeratome. The protective flap is about 30% of the corneal thickness and is hinged either along the nose or beneath the upper eyelid. A suction ring holds the eye in position while the automated microkeratome creates the corneal flap. Patients are unable to see the corneal flap being made, as the vision becomes gray when the suction is applied and the red target light disappears until the flap is completed. Most patients sense some vibrating pressure, but the microkeratome incision is completely painless. When the laser pulses are completed, the corneal flap is replaced and the natural suction within the cornea seals the corneal flap within 1 to 5 minutes. No sutures are needed, as the corneal flap seals rapidly. A bandage contact lens is not typically required with Custom LASIK and a protective eyeshield rather than a patch may be needed, but only while sleeping. Although the vision is blurry immediately following Custom LASIK, patients are able to blink normally and there is rapid overnight visual improvement.

In PRK, the removal of the surface protective layer increases the risk of pain, infection and corneal scarring or haze. The creation of the corneal flap with Custom LASIK allows the protective layer to be preserved and provides for a more rapid and comfortable visual recovery. The surface corneal layers are more sensitive than the inner corneal layers treated with Custom LASIK; therefore healing time is shorter compared to PRK. The intra-operative risks however are greater with Custom LASIK than PRK, primarily because of possible complications with the creation of the protective corneal flap with the microkeratome. For patients with higher degrees of myopia, hyperopia and astigmatism, where more healing complications are encountered, or for patients who desire a more rapid visual recovery, Custom LASIK may be the treatment of choice.

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SECTION 3: LASIK INDICATIONS, CONTRAINDICATIONS AND PERI-OPERATIVE CARE


Custom LASIK is indicated for the treatment of myopia (near-sightedness), hyperopia (farsightedness) and astigmatism
Candidates must be 18 years of age or older
Candidates must have a stable refraction with no more than 0.50 diopter change within the previous year, as the procedure will not change the natural growth or aging of the eye
Candidates must be aware that this is an elective procedure and that there are alternative forms of vision correction that are either non-surgical or surgical including eyeglasses, contact lenses, orthokeratology (ortho-K), radial keratotomy (RK), intracorneal ring segments (ICRS), automated lamellar keratoplasty (ALK), holmium laser thermokeratoplasty (LTK), refractive phakic lens implants or photorefractive keratectomy (PRK).
Candidates must be free of certain eye diseases including keratoconus, glaucoma, cataracts and certain retinal and optic nerve diseases
Candidates must be free of certain eye viruses including herpes simplex and herpes zoster Candidates must be free of certain health problems including uncontrolled diabetes, autoimmune or collagen vascular disease, any medication or condition which renders the patient immuno-compromised
Candidates must make their surgeon aware of certain eye problems including amblyopia (lazy eye), strabismus (muscle imbalance), severe dry eyes or any recurrent, residual or active eye condition which may affect healing
Candidates must make their surgeon aware of certain general health conditions including keloid scarring with previous surgical healing, back problems, claustrophobia or other psychological problems which may affect the surgery or recovery
Candidates must make their surgeon aware of any implants including a cardiac pacemaker, insulin implant or other electronic implanted device
Patients must also make their surgeon aware of any medication allergies and any medications they are taking to avoid potential drug interactions and allergic reactions
The FDA considers pregnancy and nursing to be contra-indications, although their effects on Custom LASIK have not been studied. Female patients agree to disclose to their surgeon if they are pregnant, could potentially be pregnant or plan to become pregnant within the next 6 months.

PRE-PROCEDURE AND POST-PROCEDURE CARE

The screening examination performed by your TLC eye doctor is intended to assess candidacy for refractive surgery based upon the corneal shape, prescription and other ocular and visual findings, but not to identify or treat eye disease. Ocular disease may be present prior to refractive surgery or may develop after surgery. Refractive surgery will not treat ocular disease. You should have a complete eye examination with retinal evaluation prior to refractive surgery and annually thereafter to identify and treat ocular disease. In general, patients with higher degrees of myopia have a higher risk of retinal problems, and reducing the degree of myopia with laser vision correction does not lower the risk. Patients who wear contact lenses must discontinue their use prior to Custom LASIK to allow the cornea to return to its natural contour. Soft contact lenses must be removed at least 3 days prior to surgery, and overnight use requires the lenses to be discontinued one to two weeks prior to the procedure date. Candidates with rigid gas permeable lenses must discontinue their use 1 to 3 months prior to Custom LASIK. Post-operative follow-up care with an eye care professional is required for 1 year to monitor Custom LASIK healing, then yearly for routine eye care and, for those eligible, to maintain your TLC Lifetime Commitment program. If a second enhancement procedure is needed or a complication occurs, a patient may be required to return to the TLC Center or lengthen their stay at their expense. If after one year, any further enhancement procedures are required, there will be a charge of $500.00 per eye for the specialized testing required for surgical planning. If there is new technology or other techniques available at that time that you wish to take advantage of in your re-treatment there will be an additional fee. The final clinical results are dependent upon properly following your post-operative care instructions.

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SECTION 4: PRESBYOPIA/THE MONOVISION OPTION
Many people around the age of 40 begin to have trouble reading up close due to the natural weakening of their focusing muscles, which is known as 'presbyopia'. Custom LASIK will not prevent the natural aging of the eyes or the need for reading glasses as you age, even if you do not require them now. Although farsighted patients usually improve their reading ability with Custom LASIK, it is possible that nearsighted patients may need reading glasses sooner. Monovision may allow for improved reading ability in both nearsighted and farsighted patients after age 40. The monovision option is usually selected only by candidates over 35 years of age, and simply means that we leave one eye a little nearsighted after Custom LASIK. For nearsighted patients your myopia is under- corrected in one eye, and for farsighted patients, your hyperopia is a little overcorrected to provide you with some reading ability as you age. Monovision will not eliminate your need for reading glasses for fine print, but is useful for reading your watch, opening your mail or reading price tags without readers. The disadvantage is that your distance sharpness will not be as good and you will have more difficulty with activities such as driving at night or with sports such as golf or tennis. Night driving glasses may be needed with monovision to reduce night glare. If you are in monovision contact lenses already, then the monovision option is ideal for you. A trial of monovision contact lenses by your own eye doctor is beneficial. In our experience, 85% of patients over age 40 still prefer the best distance vision possible in both eyes and wear reading glasses when needed, declining the monovision option.

I would like to have the best distance vision in both eyes

 


I would like to have monovision

 



SECTION 5: LEGAL RESPONSIBILITIES AND DISCLOSURES

CONFIDENTIALITY

By initialing below, you give permission for the medical data concerning your surgery and subsequent treatment to be submitted to TLC and its affiliates, the Excimer laser manufacturer and the governmental regulatory authorities. The data will be utilized for statistical analysis, record keeping, marketing and/or quality control. Patient identity will be strictly confidential in any dissemination of data.

GOVERNING LAW/ JURISDICTION
By initialing below, you agree that the relationship and resolution of any and all disputes between yourself and the surgeon shall be governed by and construed in accordance with the laws of the Province of Ontario. You also acknowledge with your initials that the procedure was performed in the Province of Ontario and that the Courts of the Province of Ontario shall have jurisdiction to entertain any complaint, demand, claim or cause of action, whether based on alleged breach of contract or alleged negligence arising out of treatment. You hereby agree that you will commence any such legal proceedings in the Province of Ontario and you irrevocably submit to the exclusive jurisdiction of the Courts of the Province of Ontario.

FINANCIAL INTEREST OF SOME DOCTORS
By initialing below, you also acknowledge that you are aware that some TLC doctors and/or optometric affiliates have a financial interest in this TLC Center or in TLC directly and they may indirectly benefit financially from the laser vision correction services performed at this center.

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SECTION 6: RISKS AND COMPLICATIONS
As discussed earlier, all forms of surgery carry a certain degree of risk for adverse effects and complications. Problems can be related to the surgical component of Custom LASIK or the healing component. Most surgical problems are related to the creation of the corneal flap and most healing problems develop within the first month following Custom LASIK. Most complications improve or resolve within 6 to 12 months or with retreatment, but some surgical or healing complications may result in permanent visual blurring, glare, discomfort or need for corrective contact lenses. The risk of a severe complication is dependent not only upon the functioning of the microkeratome, blade and surgical technique but upon a number of other factors including the prescription, orbital structure and corneal shape. In general, there is a small risk in the range of 1 to 5% of experiencing a complication and a very small risk, less than 1%, of a severe sight-threatening complication. Please read this section carefully for a better understanding and initial below.

The risks of Custom LASIK revolve around 5 primary areas:

1 Post-operative Side Effects, Adverse Effects and Complications
2 Refractive Complications
3 Corneal Flap Complications
4 Corneal Healing Complications
5 Other Miscellaneous Complications

1. Post-operative Side Effects, Adverse Effects and Complications
There are several adverse effects which may be encountered early in the post-operative period, including foreign body sensation, pain or discomfort, sensitivity to bright lights, blurred vision, dryness of the eyes, tearing and fluctuation in vision. Persistent pain is uncommon following Custom LASIK and may indicate a disturbance of the epithelial protective layer, displacement of the corneal flap or possible infection and should be evaluated promptly by your doctor. Corneal infection following Custom LASIK is rare but very serious and can potentially result in corneal scarring requiring a corneal transplant and in very severe cases, infections can even result in blindness. Corneal inflammation can also be produced from medication or healing reactions, which may be allergic, toxic or immune in nature. Diffuse interface keratitis (also known as Sands of the Sahara) is the most important inflammatory reaction and can produce corneal hazing, blurred vision, farsightedness, astigmatism that may result in permanent corneal irregularities. Treatment may involve topical steroids or further surgery and may or may not restore vision fully. The most common long-term side effect is dryness of the eyes, which often precedes Custom LASIK but may be exacerbated. The most important long-term side effect is night glare, starbursting, haloes or simply reduced visual quality under low light conditions. It is very common to have night glare early during the recovery course and night glare is more common when only one eye has been treated. Night visual disturbances are typically produced by the pupil size exceeding the laser treatment area. It is more common in nearsighted patients with severe prescriptions and large pupils. Some patients benefit from night driving glasses and most, but not all, patients improve substantially over 6 to 12 months. In a small percentage of patients night glare may be permanent and affect your night driving abilities.

2. Refractive Complications
Refractive problems that may be encountered include too much correction, too little correction, a prescription imbalance between eyes, aggravation of muscle imbalance problems or a loss of effect from regression. Custom LASIK may result in overcorrections and undercorrections due to the variability in patient healing patterns and other surgical variables, leaving patients nearsighted, farsighted or with astigmatism. This may or may not require patients to wear spectacles or contact lenses or to undergo further surgery. Further surgery entails additional risk and is not guaranteed to provide an ideal visual outcome, although improvement is typically achieved. Patients may also heal differently between eyes, based upon differences between eyes in pre-operative prescriptions, corneal curvature, variation in healing or other surgical variables. Differences in refraction between eyes is termed anisometropia, which is most severe when only one eye is treated, may result in a loss of depth perception, eyestrain, headache, double vision and the need for contact lenses. Both farsightedness and anisometropia may result in worsening of muscle balance problems, causing an eye to wander more or produce eye fatigue. Lastly, depending upon the severity of the original prescription, the individual healing pattern of the patient and other surgical variables, regression may occur, causing the eyes to return toward their original prescription, partially or, very rarely, completely. Further enhancement surgery may be performed when medically stable if adequate corneal tissue is available and no other medical contraindications are present. As stated previously, enhancement surgery, while generally very effective, is associated with additional risk and is not guaranteed to achieve the ideal visual result.

3. Corneal Flap Complications
The primary benefits of Custom LASIK are related to the creation of the protective corneal flap. The corneal flap must be of clinically adequate quality, thickness and size to proceed with laser treatment. Corneal flap complications range in severity from those that simply require the procedure to be postponed by 3 to 6 months, to those that create permanent corneal irregularities resulting in blurred vision. The most severe Custom LASIK complication is that of corneal perforation which has been reported several dozen times worldwide. Corneal flap complications that occur after the Custom LASIK procedure during the recovery period include displacement and wrinkling of the corneal flap and epithelial ingrowth.

Corneal flap problems include but are not limited to:

Corneal flaps of inadequate size, typically too short, preventing laser treatment and requiring the Custom LASIK procedure to be repeated in 3 to 6 months. Typically there is no serious visual disturbance, although glare and shadowing may occasionally be produced.
Corneal flaps of inadequate thickness may or may not be adequate for laser treatment, and may result in the procedure being stopped and repeated after 3 to 6 months. A thin corneal flap may result in a slow visual recovery over weeks to months and possibly permanently blurred vision with or without laser treatment.
Corneal flaps of inadequate quality or smoothness, include a variety of corneal flap problems which may produce serious permanent corneal irregularities and significant visual blurring. Corneal flap irregularities may be produced because of inadequate suction pressure, inadequate orbital size, inadequate patient cooperation, malfunction or problems with the microkeratome, blade or suction apparatus.
Corneal flaps are routinely hinged either nasally or superiorly beneath the upper eyelid. A corneal hinge is not required for a good visual result, but a hinged corneal flap is more secure and typically heals faster and more smoothly. Depending upon the corneal shape, the suction ring alignment and the microkeratome, it is possible that a free corneal cap may be produced which is not hinged to the cornea. Although the laser treatment can still be performed, if any irregularities in flap quality or thickness are noted, the corneal disc is immediately replaced and allowed to heal. If the free corneal cap is of excellent quality, then the procedure is completed, but special care must be taken during the first 24 to 48 hours not to displace or lose the corneal cap. Loss of the corneal cap may result in scarring, permanent corneal irregularity and the need for more invasive surgery.
Corneal perforation is the most serious Custom LASIK complication. Corneal perforation is prevented by the microkeratome depth plate, which is checked before each and every procedure. Some microkeratomes have fixed corneal depth plates. Perforation of the cornea requires corneal suturing and the need for an intraocular lens implant, as the natural lens is usually lost or damaged. It should be appreciated that corneal perforation may also potentially result in infection, the need for a corneal transplant or, rarely even, blindness.
Corneal flap displacement, partial or complete, occurs during the early post-operative period, typically during the first 12 to 24 hours, but may occur days to weeks later with trauma. Care should be taken to protect the eyes from trauma, as well as to avoid rubbing the eyes or forcefully closing the eyes during the first week following Custom LASIK. Partial displacement of the corneal flap may result in corneal striae or wrinkles, which blurs vision both qualitatively and quantitatively. Most corneal striae are treatable but some may be resistant to treatment, especially in highly nearsighted patients. Complete displacement of the corneal flap is often painful and requires urgent replacement. There is a higher risk of epithelial ingrowth and infection with corneal flap displacement.
Epithelial ingrowth occurs during the first month following Custom LASIK and is more likely to occur in patients with an abnormal or weakly adherent protective layer, for which age is a factor. Epithelial ingrowth is produced when epithelial surface cells grow underneath the corneal flap during the healing of the corneal flap incision. Epithelial ingrowth is more common with any trauma or breakdown of the epithelium, which is more common in Custom LASIK enhancement procedures and long-term contact lens wearers. Treatment of this condition involves lifting the flap and clearing the cells away. Although most small areas of epithelial ingrowth need only be monitored, untreated large areas of epithelial ingrowth may distort vision and may actually damage the flap integrity if severe and progressive.


4. Corneal Healing Complications
The protective corneal flap of Custom LASIK reduces the healing time of Custom LASIK refractive surgery compared to PRK, but significant healing is still required which can affect the quality and vision of the final result. Corneal healing problems with Custom LASIK are more likely to be experienced by patients corrected for higher degrees of nearsightedness, farsightedness and astigmatism, which may potentially slow visual recovery and increase the need for enhancement procedures for over- and under-corrections. Corneal healing may affect not only the speed of visual recovery but the smoothness and may produce visual blurring. Rarely, corneal scarring may be produced with Custom LASIK. The most important aspect of corneal healing following Custom LASIK or any other form of refractive surgery is the development of corneal irregularities which may permanently affect the quality, crispness and sharpness of the final visual result. Corneal irregularities, or irregular astigmatism, are produced when the cornea heals in an irregular pattern, which may or may not follow a surgical flap complication. Corneal irregularity may also be produced from abnormalities and complications of the laser treatment, including central islands and decentrations which may produce blurring, shadowing, glare and double vision. Some corneal irregularity is commonly expected for the first several weeks following an uncomplicated Custom LASIK procedure. However, if it persists beyond 6 months it is considered abnormal and may be permanent. Most corneal irregularity improves over 6 to 12 months. Some causes of corneal irregularity may be surgically managed but other causes are permanent. The greatest limitation of healing problems is that further surgical intervention does not guarantee better healing and may in fact result in a further reduction of visual quality.

Irregular astigmatism from both healing and surgical complications may result in a loss of best corrected vision, which means that a patient may be unable to read the bottom few lines of the eye chart even with spectacle or contact lens correction. Specifically, the best vision a patient measures after surgery even with lens correction may not be as good as the patient enjoyed before refractive surgery.

In certain cases, the vision may be severely impaired and affect the ability of a patient to drive legally. This is most important in patients who already have reduced visual acuity from other causes. That is, Custom LASIK is not intended to increase the visual potential of a patient. Many candidates with high prescriptions who often are unable to read 20/20 before surgery, even when corrected with glasses or contacts, should not expect to read 20/20 after surgery. Furthermore, a patient who is best corrected before surgery to 20/40 is already borderline for legal driving and any loss of best corrected vision from healing or surgical complications may prevent legal driving.

Corneal healing is very patient specific and plays a critical role not only in how well a patient recovers from a surgical flap complication but in how rapidly and smoothly all patients recover.

5. Other Miscellaneous Complications
It is important to note that it is impossible to list every conceivable complication that is not listed above. Risks and complications that are considered to be unforeseeable, remote or not commonly known are not discussed. In addition, there may be long-term effects not yet known or anticipated at the present time. The most severe possible complications would necessitate more invasive or repeated corneal surgery, including corneal transplantation, and could potentially produce partial or complete loss of vision.

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SECTION 7: EXPECTATIONS OF THE PROCEDURE
The goal of Custom LASIK is to achieve the best visual result the safest way. The goal is not to eliminate glasses and contacts completely but to dramatically reduce your dependence upon them in an attempt to help improve your quality of life. Night driving glasses and reading glasses may always be needed even when an excellent visual result is achieved. It is also important to recognize that even 90% clarity of vision is still 10% blurry and glasses may still be needed for certain activities that require fine or detailed vision.

Enhancement procedures can be performed when the cornea is stable unless medically unwise or unsafe. Adequate corneal tissue must be available to proceed with an enhancement procedure, and a repeat measurement of the residual corneal thickness will be taken. Typically patients considered for an enhance-ment procedure should have at least 1.00 diopter of residual hyperopia, myopia or astigmatism or unaided vision of 20/40 or worse. Enhancement procedures are performed after 1 to 3 months, once adequate corneal healing and stability is achieved. Enhancement procedures are typically performed by lifting the original flap during the first few months before full healing occurs, or by creating a new corneal flap. There are always risks which must be balanced against the benefits of performing further surgery.

Complications are an inherent part of surgery and despite our best efforts, training and skill, we recognize that some patients will experience problems. It is simply our hope to educate you as to what those problems may be so that you can make an informed decision whether or not to proceed. No one ever believes that they will be in the small percentage of people that develops a significant complication, so it is important for all candidates to appreciate that there are truly no guarantees.

SECTION 8: TREATMENT OF ONE OR BOTH EYES
There are both advantages and disadvantages to having Custom LASIK on both eyes on the same day. The benefits of surgery on both eyes during the same session begin with the simple fact that patients often prefer this option as it is more convenient, with respect to either work or home life. Patients may also feel that their vision feels more balanced, with improved depth perception, and night glare may dissipate more rapidly. Some patients find they have less anxiety, while others prefer the safety of treating only one eye at a time to allow visual recovery of the first eye prior to proceeding with the second eye.

The primary risks of treating both eyes on the same day are related to unrecognized surgical complications or, more commonly, unexpected healing complications, which can produce either temporary or permanent visual blurring. Adequate visual recovery from laser vision correction for activities such as driving, as well as returning to work, may take 1 day or 1 month, or even longer in patients who respond abnormally, whether one or both eyes are treated. If both eyes are treated, then visual recovery may be prolonged and there is no way to predict who will take longer to heal. There is also no opportunity to learn from the healing pattern of the first eye. If there is an undercorrection or overcorrection in one eye, this is likely to occur in both eyes and both eyes will require retreatment. Other healing complications may also affect both eyes. Most importantly the risk of infection may result in severe scarring, corneal transplantation and even complete loss of vision in both eyes.

Please initial in the appropriate box below and indicate on the front of the Informed Consent as well.

I would like to have BOTH EYES treated together

 



I would like to have only my RIGHT EYE treated today

 



I would like to have only my LEFT EYE treated today

 



SECTION 9: WRITTEN CONFIRMATION

Please write in your own handwriting the following two statements to confirm that you have understood and accept that Custom LASIK is an elective surgical procedure and, as with all surgical procedures, the result cannot be guaranteed. That you acknowledge that although vision-threatening complications are quite rare, it is possible that partial or complete loss of vision may be produced as a result of a surgical or healing complication. That the procedure may not eliminate all of your myopia, hyperopia or astigmatism and that additional correction with glasses, contact lenses or further surgery may be required.

I understand that "there are risks and that there are no guarantees"






I understand that "I may still need to wear glasses"






SECTION 10: VOLUNTARY CONSENT
Please sign below that you have carefully reviewed this informed consent document and that you have had an opportunity to have any questions that you may have had answered. By signing below you also indicate that you are aware that Custom LASIK is an elective procedure, that you do not need to have this procedure and that you understand your other surgical and non-surgical alternatives for vision correction.

Custom LASIK represents a new technique utilizing wavefront technology and corneal topographic information, which potentially can provide patients with superior visual results by correcting both prescription data and visual aberrations within the eye. Custom treatments however are early in development and therefore it must be recognized that there can be no guarantee as to their visual outcome compared to standard LASIK programs or that the visual results may be worse. There are also no long-term studies available to determine the side effects of Custom LASIK and the implications of correcting visual aberrations. It is believed that having superacuity at distance may increase the need for reading glasses for near tasks beyond age 40. While Custom LASIK is believed to be an advanced form of Laser vision correction with greater visual outcome potential, there are no guarantees that this technique will not be harmful. Custom LASIK as well is still subject to the same surgical and healing risks associated with standard LASIK outlined in this informed consent. Finally, it must be understood that the final visual result with Custom LASIK is always dependent upon the individual healing of the cornea, the customized treatment program simply provides the potential for superior visual results.

Patient Full Name: (Print) __________________
Patient Signature: __________________
Witness Full Name: (Print) __________________
Witness Signature: __________________
Surgeon Name: __________________
Surgeon Signature: __________________
Date of Procedure: __________________