Informed Consent for Laser Vision Correction (LVC) LASIK: Laser in situ Keratomileusis PRK: Photo Refractive Keratectomy PTK: Photo Therapeutic Keratectomy IT IS VERY IMPORTANT THAT YOU READ THIS INFORMED CONSENT FORM. PLEASE INITIAL EACH PAGE WHERE INDICATED. DO NOT SIGN THIS FORM UNLESS YOU HAVE READ AND UNDERSTAND EACH SECTION. Patient Name Surgeon Name Co-Managing Doctor Date of Surgery Treatment
Right Eye PRK LASIK PTK PTK ENH TRAD CUST
Left Eye PRK LASIK PTK PTK ENH TRAD CUST
Mono-Vision
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Surgeon Note:
INTRODUCTION It is our hope to fully inform you concerning the side effects, limitations and complications of Laser Vision Correction (LVC) 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 prepared to deal with any unexpected complication or side effects, which may arise. LVC 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. Among alternatives are: eyeglasses/spectacles, contact lenses, photorefractive keratectomy (PRK), radial keratotomy (RK), automated lamellar keratoplasty (ALK), orthokeratology, hexagonal keratotomy, corneal relaxation incision, and intracorneal ring segments (Intacts™). However, all of these alternatives have associated risks as well. Initial BACKGROUND Laser in situ Keratomileusis (LASIK), a form of laser vision correction (LVC), 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 ways that the cornea can be reshaped with laser surgery. It can be accomplished on the surface with
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PRK (photorefractive keratectomy) or beneath the surface with LASIK, under a corneal flap. Specifically, the excimer laser produces a cool beam of ultraviolet light energy, which when focused through a lens system, results in the precise removal of tissue to change the shape or curvature of the cornea. PTK (Phototherapeutic Keratectomy) can be performed like PRK (on the surface of the cornea) or like LASIK (beneath the surface of the cornea under a flap). PTK allows the surgeon to manually select the shape (e.g. circle or oval), the axis, the blend, and the depth of the laser ablation in microns. Therefore, your surgeon may select the use of a PTK treatment during your LASIK or PRK enhancement procedure to treat scars or minimize the amount of tissue removed to treat any residual myopia. While most patients chose either a custom or traditional laser treatments to treat their myopia or hyperopia, and or astigmatism, a minority of patients (who are candidates for PTK and who only have myopia and no significant astigmatism) can select to undergo PTK as their primary procedure to save costs and/or minimize tissue removal. In the PRK procedure, the corneal epithelium (the outermost layer of cells) is gently removed by the surgeon. Excimer laser energy is then delivered to the surface of the cornea in order to reshape it. The epithelium grows back, in most cases, during the first 5 days after the procedure. LASIK is a variation of keratomileusis, a procedure that has been used for many years. A suction ring is attached to the eye, securing it for the microkeratome cut. When the suction is applied, the patient’s vision will appear completely gray; patients cannot see or feel the incision. Using a microkeratome, a very sophisticated surgical instrument, or a laser (IntraLase™) the surgeon will shave the top portion of the cornea to create a hinged flap of tissue, then the excimer laser is used to reshape the cornea beneath the surface. The surface flap of tissue is then replaced and heals quickly without sutures. In the PRK procedure, the surface cells of the eye that are removed are more reactive. Therefore, PRK may produce more discomfort the day after surgery. The intra-operative risks however are greater with LASIK than with PRK primarily due to possible complications with the creation of the flap. Initial DIAGNOSIS You have been diagnosed with myopia (nearsightedness), or hyperopia (farsightedness), with or without astigmatism. INDICATIONS FOR LASER VISION CORRECTION (LVC) PROCEDURES LVC is intended for: Patients whose stable refraction is within +/- 0.50 diopters for 1 year prior to laser treatment Patients who are at least 18 years of age Patients who have been clearly informed of all alternatives CONTRAINDICATIONS FOR ALL PATIENTS By initialing below, you are certifying that you are at least 18 years of age. You also confirm that you understand that the following conditions may present a reason not to undergo LVC surgery, so you agree to disclose these or other medical conditions to your eye doctor.
Vascular disease Autoimmune or Immunocompromised disease or on drug therapy suppressing the immune system Keratoconus (patients with this condition may have unstable corneas) Pregnancy Herpes Simplex or Herpes Zoster Virus Residual, recurrent, or active ocular disease(s) or abnormality except for myopia or hyperopia in either eye Unstable or uncontrolled diabetes Progressive myopia or hyperopia Amblyopia (lazy eye) Glaucoma; or Presence of a pacemaker, insulin implant or other implanted electronic device in the patient
In addition, you should inform your physician of any medications you may be taking so as to account for the risk of allergic reactions, drug reactions, and other potential complications during LVC surgery and subsequent treatment. Initial
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FEMALE PATIENTS ONLY: You should understand that pregnancy could adversely affect treatment results. By initialing below, you are confirming that you are not pregnant, nursing, or plan to become pregnant in the near future. If it is possible that you are pregnant, you agree to take a pregnancy test before undergoing the LVC procedure. If the results are positive, you agree that you will not undergo the LVC procedure unless the results are proven incorrect, or you will reschedule treatment after pregnancy. If you do become pregnant in the 6 months following treatment, you agree to notify your eye doctor immediately. Initial
PRE-PROCEDURE EXAMINATION: The screening examination performed by your eye doctor is intended to assess a patient’s suitability for refractive surgery based upon a patient’s refraction (i.e. visual acuity) amid other factors but not to identify or treat ocular 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 at least once a year to identify and treat ocular disease. Initial CONTACT LENS WEARERS: Patients who wear gas-permeable or hard contact lenses must completely stop wearing such lenses at least (3) weeks prior to the LVC procedure. This period may be longer for some patients. Patients who wear soft contact lenses must completely stop wearing their soft contact lenses for at least three (3) days prior to the LVC procedure and possibly longer. Initial FOLLOW-UP EXAMINATIONS: Patients are requested to return for follow-up exams several times during the first year following LVC in order to monitor healing following surgery. If an enhancement is needed or a complication occurs, a patient may be required to return or stay longer. Following your doctor’s instructions for post-operative care is a very important factor of the success of the procedure. Initial CONFIDENTIALITY: By initialing below, you give permission for the medical data concerning your surgery and subsequent treatment to be submitted to Beyer Laser Associates, LLC, and affiliates, to the manufacturer of the excimer laser, and to regulatory authorities or otherwise used for record keeping, statistical analysis, marketing, and/or quality control. Patient identity will be strictly confidential in any dissemination of such data. Initial GOVERNING LAW/ JURISDICTION: By initialing below, you agree that the relationship between yourself and the surgeon shall be governed by and constructed in accordance with the laws in the state of Colorado. You also acknowledge that the procedure was performed in the State of Colorado and that the courts of the state of Colorado shall have jurisdiction to entertain any complaint, demand, claim or cause of action, whether based on alleged breach of contract or alleged negligence arising from the treatment. You hereby agree that you will commence any such legal proceedings in the State of Colorado and you submit to the jurisdiction of the courts of the State of Colorado. Initial RISKS AND COMPLICATIONS: The majority of potential reactions/complications after the LASIK or PRK procedure can occur in association with the healing process that takes place during the first week after the procedure. Therefore, it is important that you either stay in town after the procedure or you do not travel to a remote locate where you can not have access to an experienced LASIK surgeon. The vast majority of these potential complications can be treated successfully if treated within 24 to 48 hours of onset. Any side effects resulting from these potential complications usually resolve within one to three months after the procedure. However, it is possible that some of these reactions/complications could be long-term or permanent.
PAIN may be experienced during the first 24-48 hours after surgery. However, the risk of pain is reduced dramatically with the LASIK or if a non-steroidal, anti-inflammatory eye drop such as Acular™ is used prior to the PRK procedure. Patients may be light sensitive. Fortunately, pain is not always a sign of complication, but daily or more frequent examinations may be required if pain is persistent. Initial
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NIGHT VISION DIFFICULTY or NIGHT GLARE or HALOS is very common early on in the healing process and is more common when only one eye has been treated. Glare is a sensation produced by bright lights causing discomfort and annoyance. Halos are hazy rings surrounding bright lights at night. A patient’s vision may not seem as sharp at night as during the day, and the patient may need to wear glasses at night. Typically, six months after both eyes have been treated, only a small percentage of patients still experience significant night glare or halos or other difficulty with their night vision which interferes with their night driving. Patients with large pupils and severe myopia are at greatest risk for night glare. In the FDA clinical trials for the VISX laser for PRK, these conditions occurred in less than 4 % of patients. Initial ANISOMETROPIA When only one of the patient’s eyes is treated and the unoperated eye is nearsighted, this may result in anisometropia (where two eyes do not focus in the same place), or aniseikonia (difference in imaging sizes between the two eyes). This can cause eyestrain, headache, and/or double vision or difficulty with distance or depth perception. A patient may have to wear a contact lens or possibly glasses for the unoperated eye to correct this condition. Initial BLURRINESS/LOSS OF BEST-CORRECTED VISUAL ACUITY Blurriness is very common during the healing process. After LASIK, there is considerable improvement in vision within the first several days. It generally requires 1-7 days until vision is clear enough to drive. However, it may take longer. Approximately 80% of visual recovery occurs within the first several days with the last 20% of the vision improving over 3 months and up to a year. Approximately 1-2% of patients independent of the procedure performed will develop corneal irregularities reducing the sharpness, crispness, and clarity of their vision preventing them from reading the bottom 2 or more lines on an eye chart that glasses, contacts, or another surgery cannot restore. That is, initial blurriness resolves in approximately 98-99% of patients over 6-12 months; it may be permanent, however, in approximately 1-2%. A patient who loses sharpness will have vision that is permanently worse. All forms of eye surgeries possess the same if not higher risks. In the FDA clinical trials for the VISX excimer laser for PRK, fewer than 1% of patients experienced blurriness. Loss of best corrected visual acuity means that the best vision you can achieve with glasses or contacts after LVC may not be as good as the best vision you achieved with glasses or contacts before LVC. Therefore, it is possible that a patient may not be correctable to 20/20 after the procedure (even though they were before the procedure) should a healing or surgical complication occur. In the VISX FDA clinical trials for PRK, a loss of best-corrected visual acuity occurred in less than 1% of patients at one or more years after the procedure. Initial OVER-CORRECTION LVC may result in over-correction causing the eye to become farsighted (hyperopic) as a result of the healing process of the eye, which may or may not require the continuing wear of corrective lenses or increased dependence on reading glasses. The occurrence of over-correction in the FDA clinical trials for the VISX laser for PRK was less than 1% of patients at one year after treatment. If this occurs and you are annoyed by the over-correction, you may be eligible to have an additional laser procedure to alleviate the over-correction. Initial UNDER-CORRECTION A patient may not get the full correction desired from LVC and some degree of nearsightedness could remain as a result of the healing response of the eye. A patient may need to continue to use glasses or contact lenses. The occurrence of under-correction in the FDA clinical trials for the VISX laser for PRK was less than 1% of patients at one year after treatment. In many cases, but not all, an additional enhancement procedure may be done to further improve vision. While an enhancement procedure does not guarantee improvement, it very often significantly improves your distance vision. Initial EPITHELIAL INGROWTH During the first 24 hours, the epithelial protective layer grows over the corneal flap. There is a small risk that epithelial cells may grow underneath the flap. This is more common in people with weak protective layers which bond poorly to the surface of the eye (age is a factor in this circumstance). Any intra-operative breakdown of the protective layer may increase the incidence of epithelial ingrowth. There is also an increased risk of epthelial ingrowth in LASIK retreatment procedures (i.e. a second treatment). Treatments of this type involve lifting the flap and clearing the cells. Untreated epithelial ingrowth may distort vision and may actually damage the flap. Small ingrowths do not usually present any visual problems and need only to be monitored. Initial
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REGRESSION/OTHER CHANGES TO THE EYE You may experience regression in the visual acuity initially obtained from LVC, so vision may partially, or in rare instances, completely return to the level where it was prior to having this procedure. This might occur soon after surgery or years later. Again, LVC does not stop the natural aging process. In addition, LVC will not prevent you from developing naturally occurring eye problems such as glaucoma, cataracts, retinal degeneration or retinal detachments. Initial CORNEAL FLAP COMPLICATIONS The entire incision time is only a few seconds during the LASIK procedure, but during this brief interval there is a small risk that the eye will experience a corneal flap complication, and a smaller risk that the complication will be severe. For example, inadequate suction pressure could result in a corneal flap that is too thin which may result in (1) postponing the procedure for a few months; (2) performing the procedure but experiencing a prolonged recovery; and/or (3) the surgeon having to convert to PRK instead of LASIK, and/or (4) temporary or permanent blurred vision. The microkeratome or Intralase™ could malfunction and the procedure could be stopped before completion. If the microkeratome or Intralase™ malfunctions before completion of the LASIK procedure, the corneal flap would have to be replaced without completing the procedure, and the eye must be allowed to heal for as short as 1 day or possibly up to 6 months before the entire LASIK procedure can be performed again to completion. In most cases, this type of complication does not result in any permanent damage to the eye. In the LASIK procedure, instead of the microkeratome making a hinged flap as intended, the entire portion of the central cornea (disc) could be removed. In that case, the disc would be replaced after the laser treatment. The doctor may elect to perform the excimer laser portion of the procedure with the disc removed or to replace the disc and wait a few months before performing the procedure again. If the top portion of the cornea is removed, the disc could be lost. The possibility of the loss of the corneal disc exists even days or weeks following the LASIK procedure. Should this occur, an additional surgical procedure requiring an auto graft of corneal tissue would be necessary; however, this is very rare. It is possible that irregular healing of the corneal flap after LASIK could result in a distorted cornea. This would mean that glasses or contact lenses might not correct the patient’s vision to the level that existed before surgery. Corneal flap incisions, which are too short, necessitate postponing surgery for a few months. Initial CORNEAL SENSITIVITY After LASIK, the eye may be more fragile to trauma from impact for the first several weeks or even months. Evidence has shown that, as with any scar, the cornea will not be as strong after healing as the original cornea was at the site of the incision of the microkeratome. Therefore, the eye is somewhat more vulnerable to all varieties of injuries after the LASIK procedure, at least for the first year after surgery. It will be advisable to wear protective eyewear when engaging in sports or other activities where the risk of contact with traumatizing objects may be high (i.e. a ball, projectile, elbow, fist, etc.). Initial PRESBYOPIA/MONO VISION Presbyopia, the normal aging process of the internal near-focusing structures of the eyes, naturally causes people to need reading glasses in their 40’s or 50’s. If you wear bifocals or reading glasses now, you may still need reading glasses after LVC. If you do not wear reading glasses now, you will most likely need them as you age, whether or not you have LVC. LVC does not stop the natural aging process. It is possible that in some patients a full correction of distance vision with the laser procedure may mean that reading glasses are needed at an earlier time than if the patient did not have the laser procedure. One possible option is monovision. The aim of monovision is to have the non-dominant eye slightly under-corrected (i.e. not fully corrected for distance vision), in order to help reading vision (i.e. near vision). This involves giving up some distance sharpness. Night driving glasses are more common with patients who have monovision and reading glasses may still be required for fine print or prolonged reading, but overall dependence upon glasses and contacts is still dramatically reduced. Monovision helps with simple near tasks such as opening mail, reading price tags, or looking at one’s wristwatch. Patients who desire the best distance or night vision unaided (such as golfers) should avoid monovision. In our experience, people less than 40 years old should not consider monovision. Slight monovision may be helpful for patients over the age of 40, and for patients over 50 years of age, full monovision may be recommended. Patients should understand that some monovision treatments do not meet the parameters for a custom treatment. In that case, your physician will perform a traditional treatment on your near eye. Monovision
Yes
No
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IRREGULAR ASTIGMATISM The smooth surface of the cornea may heal in an irregular pattern. Some irregularity is common for the first several weeks. If irregular astigmatism persists beyond six months, we then consider it abnormal and in rare cases it could be permanent. This can result in blurriness and loss of best-corrected visual acuity. In the FDA clinical trials for the VISX laser for PRK, irregular astigmatism occurred in less than 1% of patients. Initial CENTRAL ISLANDS With this condition, the cornea heals in an irregular fashion within the central 3.0 mm. This results in decreased best-corrected and uncorrected acuity, doubling or shadow images. If this does occur, it may be self-limiting, resolving on its own within one to six months. If it does not resolve itself within that time, then an additional laser procedure may be necessary In the FDA clinical trials for the VISX laser for PRK, this occurred in less than 1% of patients. Initial DECENTERED ABLATION This condition means that the laser’s ablation or “zone” of correction is not aligned with the patient’s visual center or axis. If this occurs, it can result in glare, especially at night. An additional laser procedure may be needed to correct this condition. However, in rare cases it may not be treatable. In the FDA clinical trials for the VISX laser for PRK, a decentered ablation occurred in less than 1% of patients. Initial SCAR TISSUE or HEALING HAZE Healing haze consists of collagen proteins that develop on the surface of the eye during the normal PRK healing process. Mild haze may not be noticeable by the patient and usually clears over time. However, more severe haze usually seems like a dirty windshield type of appearance to your vision. Haze is not the initial blurriness you will experience but may become evident after surgery, developing over weeks or months. Even if scar tissue develops, it usually can be treated with another laser procedure. Scarring may be persistent or infrequently recurrent, requiring multiple surgeries and possibly producing loss of visual sharpness or over-correction. In the FDA clinical trials for the VISX laser for PRK, the above complications occurred in less than 1% of cases. The use of intraoperative Mitomycin C in high risk cases (eg. patients with high myopia or who had previous corneal surgery such as Radial Keratotomy) has significantly reduced the rate of this complication. Initial OTHER COMPLICATIONS Other possible complications that may be associated with the LVC procedure include elevation of intra-ocular pressure, non-reepithelialization of a treatment spot or corneal epithelial defect, cataract (cloudiness of the lens), corneal scarring, corneal swelling, corneal ulceration or inflammation, dryness of the eye, irregularities of the cornea (corneal deposits, microcysts), endothelial cell loss (a loss of endothelial cell density, increase in irregularity of cell size or shape which may result in corneal swelling), inflammation of the iris, retinal detachment, hemorrhage, itching, double vision, drooping of the eyelid, contact lens intolerance, and reading difficulty. One healing reaction may be an immune or toxic reaction known as Diffuse Lamellar Keratitis (DLK) or “Sands of Sahara”. This may reduce vision and could require further treatment including steroids or other topical medications as well as surgical intervention. Although these conditions are rare, it is possible that complications may result in the need for corneal surgery (i.e. corneal transplant) or even blindness. There are also potential complications due to anesthesia and medications that may involve other parts of your body. It is important to note that it is impossible to list every conceivable complication that could occur with excimer laser surgery and that there could be a complication that is not listed above. Risks and complications that are considered to be unforeseeable, remote or commonly known are not discussed. In addition, there may be long-term effects not yet known or anticipated at the present time. Initial
ANTIBIOTIC/STEROID EYEDROPS Postoperative drops are typically used for 4-7 days (in some cases longer) after LVC. It is very important that you follow your doctor’s instructions regarding the use of eye drops after the LVC procedure, as this can affect your final visual outcome. Initial RISK OF SEVERE COMPLICATIONS Although only about 1% of patients may develop severe complications, NO ONE ever believes they will be in that 1%. There are no guarantees of perfect vision, no guarantees of zero glasses or contact lenses, and no guarantees that you will not be among the few people that have significant complications. Some of those results are quoted above, but not all of them. However, these statistics are for general information only. Since the FDA clinical trials, there
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have been advances in the science and medical art of excimer laser procedures. Therefore, it is NOT likely that your doctor will use the exact same protocols and procedures as used in the FDA clinical trials. Your doctor is likely to have experienced different results and complication rates than the results of the clinical trials. Initial EXPECTATIONS The goal is to achieve the best visual result in the safest possible way. The goal is NOT to eliminate glasses and contacts completely but to dramatically reduce the dependence upon them in an attempt to help improve the quality of life. Night driving glasses and reading glasses may be needed. Even 90% clarity of vision is 10% blurry. Enhancement surgeries can be performed when your eyes are stable UNLESS unwise or unsafe. Typically if a -1.00 diopter or higher remains or vision is at 20/40 or worse, an enhancement may be performed. Enhancement surgeries cannot be performed for at least 4-12 weeks, usually after adequate healing and stability occurs. If there is inadequate tissue, it may not be possible to perform an enhancement. Your surgeon can discuss with you the benefits and risks of an enhancement surgery if necessary. Initial IMPROVEMENT OF VISUAL POTENTIAL Patients who do not see 20/20 or 100% before surgery, even with the strongest prescription, cannot expect or anticipate 20/20 or 100% after surgery. That is, after surgery the best vision a patient can attain is the vision they experienced pre-operatively with their glasses or contact lenses. Rigid gas permeable lenses may actually provide certain patients with better vision than glasses, soft lenses and refractive surgery. This surgery does not improve visual potential. Nearsightedness represents multiple visual problems, of which your prescription is only one. That is why each patient will continue to require routine annual eye examinations to rule out several other associated conditions, primarily to assess the retinal nerve tissue quality, which this procedure does not directly affect. It is the reduced retinal nerve tissue quality which prevents some individuals from reading 20/20 with full correction. Approximately 20/40 is legal driving vision. If you cannot achieve corrected vision of 20/40 or better you may not qualify to renew your driver’s license. Patients with borderline visual function must understand that a loss of sharpness may prevent them from driving legally. Initial MITOMYCIN C MMC is a medication that has been used in the medical field for a number of decades. It has been as an anti-cancer drug because it can stop the proliferation or growth of certain types of cells such as those seen in tumors, and also those cells in the eye which produce scarring or haze. MMC has been used in the eye since the 1980’s to prevent scarring after many types of surgical procedures, such as glaucoma filtration and pterygium surgeries. The use of MMC for treatment and prevention of corneal haze is a relatively new indication for this medication. Beyer Laser Center has routinely been using MMC following PRK for high myopia and hyperopia, PRK over previous radial keratotomy (RK) surgery, phototherapeutic keratectomy (PTK) or PRK over previously scarred or hazed corneas and PRK over Forme Fruste Keratoconus, Keratoconus and eyes with Pellucid Marginal Degeneration. MMC is a very potent and potentially toxic under certain circumstances. Some of the eye-related complications that have been reported following the use of MMC (for other conditions) include but are not limited to: conjunctival infection (redness of the eye), permanent stem cell deficiency, decompensation, cataract and retinal vascular occlusion. The complications listed above were seen following various types of eye surgeries, but no complications have been reported following this technique, as described, for corneal haze removal and prevention. This technique uses a low dose (0.02%) of MMC delivered to the central cornea for 10 to 30 seconds only. This technique minimizes the chance of complications, (compared to the types of surgeries in which MMC has been associated with such complications). Beyer Laser Center has treated several hundred eyes with MMC, both for haze induced by prior refractive surgery and as a preventative measure at the time of surgery. Additionally, a number of internationally renowned eye surgeons from around the world have embraced this technique. All patients with haze have seen improvements in visual acuity and a decrease in corneal haze. Those patients that received preventative MMC treatment have not experienced corneal haze over an average follow-up period of 1 year. However, there is no guarantee that you will obtain a similar result. The possibility does exist, that over longer periods of time, corneal haze and/or unforeseen toxicity may develop in the future. I have been explained that the use of MMC in eye surgery is considered ‘off label’ for an FDA approved medication. I understand that there are no guarantees as to the success of the procedure in removing or preventing haze and that toxic side effects may develop. Initial
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IN YOUR OWN HANDWRITING, PLEASE WRITE THE INDICATED QUOTES IN EACH BOX: 1.
I understand that, as with any form of surgery, the outcome can never be guaranteed. I specifically understand that the benefits of LVC also cannot be guaranteed. LVC may be of no benefit to me and may in fact be harmful. Please write in the box below: “I may not achieve the result I hope for.”
2.
I understand that the correction obtained may not eliminate all of my myopia, hyperopia, or astigmatism and that additional correction with glasses, contact lenses, or further surgery may be needed. Please write in the box below: “I may still need to wear glasses.”
3.
I understand the basic nature of the procedure as well as the possible risks and benefits of LVC. I have decided to undergo LVC with the excimer laser. I understand that it is impossible for my surgeon to inform me of every conceivable complication that may occur. Although visionthreatening complications are quite rare, it is possible that if a significant reduction in vision is produced as a result of a complication, I may require a corneal transplant. Blindness resulting from LASIK may occur as a result of infection or other sight threatening condition under very rare conditions. I understand that partially and fully sighted eyes have been treated with the excimer laser worldwide since 1988. The very long-term effects associated with this procedure are not known. Please write in the box below: “There are risks and there are no guarantees.”
4.
I understand that as a result of surgery using the excimer laser that there is a small risk that my vision may be made worse from the laser surgery. Please write in the box below: “My vision may be made worse.”
5.
I have been informed of alternative treatments of my myopia, hyperopia, and/or astigmatism, including glasses, contact lenses, and other surgical procedures such as RK, and AK. I understand that I do not have to have the LVC procedure and that it is not a reversible procedure. A copy of this consent form is available to me upon request and all of my questions have been answered to my satisfaction. Please write: “All my questions have been satisfactorily answered.”
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MILITARY PERSONEL, PILOTS, AND THOSE WHO MAY HAVE A FORM OF EMPLOYMENT THAT PREVENTS ANY TYPE OF ELECTIVE EYE SURGERY Very rarely, certain professions may expressively prohibit any type of elective eye surgery. In other cases, these professions may prohibit LASIK eye surgery while permitting PRK eye surgery. In either case, it is soley your responsibility to determine whether your profession, or planned profession, will permit you to undergo the type refractive surgery you are consenting to undergo. Please write: "I do not have professional restrictions to undergo LVC surgery"
It is possible for your procedure to be viewed via live closed-circuit, in-house television and through our viewing windows. By initialing here, you consent to having your procedure viewed by individuals in our practice at the time of surgery.
Initial
VOLUNTARY CONSENT In signing this Informed Consent Form, I certify that I have read the preceding information and understand the contents. I fully understand the possible risks, complications, and benefits that can result from the excimer laser surgery. My decision to proceed with laser vision correction has been voluntarily and freely given. RIGHT EYE
Primary
Enhancement
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Enhancement
Patient Full Name (print) Patient Signature Witness Full Name (print) Witness Signature Surgeon Co-Managing Doctor* Date of Procedure LEFT EYE Patient Full Name (print) Patient Signature Witness Full Name (print) Witness Signature Surgeon Date of Procedure
* If you have a co-managing doctor, your doctor will receive a percentage of your surgery payment to manage your post-operative and/or preoperative care. However, if you have any concerns at any time, please contact your surgeon at 303 499 2020. LVC-US-AMO
Revision Date: September 23, 2009
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