LASIK: Assumption of post-op care
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NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.
Version 11/01/06
MODEL FORM
This form assumes that if you have to do any specific procedure, you will have a discussion with the patient regarding the risks, benefits and alternatives related to that particular surgery or treatment e.g. an enhancement. This “informed consent” is simply setting forth an understanding between the patient and the practice on certain issues of overall care.
ASSUMPTION OF LASIK POST-OP CARE
I understand (practice/physician name) will treat the current condition of my eye/eyes secondary to previous refractive procedure performed by a surgeon at a facility which was not associated with the (practice/physician name). (practice/physician name) informed me of my option to return to the surgeon who performed the procedure but it is my choice to be treated at (practice/physician name). My reason(s) for choosing to be treated at (practice/physician name) instead of returning to the refractive surgeon is(are)
(In patient’s own handwriting to show that she had her own reasons to stay with you.)
I understand that the (practice/physician name) in no way guaranteeing any cure of my current condition which includes
(In patient’s own handwriting to document in her own words the complaints/reasons for being at your practice. If simple, uncomplicated post-op follow-up then let her state that).
I also understand that the (practice/physician name) is not accepting any liability or responsibility for the loss of vision or diminished quality of vision associated with the prior surgery.
I have had possible associated risks and consequences of treatment versus no treatment explained to me. As with all types of treatment, I understand there is the possibility of complications and an unsuccessful resolution of the current condition.
I understand that I will be charged at normal (practice/physician name) fees for service. Payment for those services will be made on the day of the exam or subsequent treatment. (practice/physician name) has answered all my questions about my proposed course of treatment at this time.
Patient Signature Date
Witness Signature Date
LASIK Retreatment Original Flap
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NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT. Version 7/19/06
Consent for LASIK (Laser In Situ Keratomileusis) Retreatment By Lifting the Original Flap
INTRODUCTION
It is our hope to fully inform you about the indications, side effects, limitations, and complications of repeat LASIK surgery, or retreatment. This consent form, in combination with the 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. It is important to realize that even if you did not experience any difficulties with your original LASIK procedure, that does not mean that you will not have any complications with the retreatment. The only way in which a patient can avoid all surgical risks is by not proceeding with surgery. Each patient must balance the risks and benefits to determine whether to proceed with further surgery.
INDICATIONS AND ALTERNATIVES
As you were informed before your first LASIK procedure, retreatments are at times indicated to correct remaining or induced myopia (nearsightedness), hyperopia (farsightedness), and astigmatism. There is no guarantee that repeat LASIK will correct these problems. Alternative forms of vision correction exist, including eyeglasses, contact lenses, orthokeratology (ortho-K), radial keratotomy (RK), intracorneal ring segments (ICRS), holmium laser thermokeratoplasty (LTK), or photorefractive keratectomy (PRK).
ELIGIBILITY FOR RETREATMENTS
The ophthalmologist alone can determine whether or not you are a candidate for retreatment. Several factors determine eligibility. LASIK retreatment procedures are performed by lifting the corneal flap and applying additional laser to the corneal bed. An enhancement can be performed once the vision and prescription (refraction) stabilize after the original LASIK procedure, which takes between one to four months for most patients. Typically, the higher the attempted correction for the original procedure, the longer it takes for the cornea to heal. Many surgeons wait three months before retreating any patient, others treat those with low prescriptions after one to two months. The corneal flap can usually be easily lifted during the first two years, and in many cases, it can even be lifted after several years. The ideal time for a retreatment is when the refraction is stable. There must be adequate corneal tissue under the flap to safely perform the reoperation and this can be measured at the time of the surgery. The remaining corneal thickness is an important factor the surgeon considers when deciding whether a retreatment can be safely performed.
RETREATMENT TECHNIQUE
During the re-treatment procedure, after the original flap is lifted, the flap is flipped over out of the way, and the laser application is performed within the corneal bed instead of on the corneal
surface as with PRK. The flap is replaced immediately following the laser application. The flap
is held in position through an almost immediate suction-type action within the cornea and by the protective layer of the cornea called the epithelial layer, which rapidly envelopes the surface within days. In most cases no stitch is required. If a stitch is required, it is below the surface and usually removed within several days. A soft contact lens may be applied as a bandage to protect the surface for the first day or so.
Rarely, the surgeon may choose to perform the retreatment on the surface of the cornea without lifting the flap. This option is usually chosen to enhance the safety of the retreatment and to provide the best quality of vision.
COMPLICATIONS
The risks associated with the original LASIK procedure apply to retreatment as well. It is not possible to list every complication. Some risks and complications may not be known, including long-term risks. The most severe complications would require more invasive or repeated corneal surgery, including corneal transplantation, and could potentially cause partial or complete loss of vision.
POSTOPERATIVE SIDE EFFECTS AND COMPLICATIONS
1. Early in the postoperative period, you may experience a foreign body sensation, pain or discomfort, sensitivity to bright lights, blurred vision, dry eyes, tearing, or fluctuations in vision. Discomfort is more common during the first few hours after surgery with retreatment than with the original LASIK procedure. Persistent pain is uncommon, and may indicate a disturbance of the epithelial protective layer, displacement of the corneal flap, or a possible infection. You should immediately notify the surgeon if you have persistent pain.
2. Corneal infection following LASIK enhancement is rare but if serious can cause corneal scarring and require a corneal transplant. In very severe cases, blindness can result.
3. Corneal inflammation can be caused by medications or healing reactions which can be allergic, toxic, or immune in nature. Diffuse interface keratitis (also known as the Sands of the Sahara) may occur with both primary and repeat LASIK. This inflammatory reaction can cause corneal haze, blurred vision, farsightedness, astigmatism, or permanent corneal irregularities. Treatment may involve topical steroids or further surgery, and treatment may or may not fully restore vision.
4. I understand that there is an increased risk of eye irritation related to drying of the corneal surface following the LASIK procedure. These symptoms may be temporary or, on rare occasions, permanent, and may require frequent application of artificial tears and/or closure of the tear duct openings in the eyelid.
5. After refractive surgery, a certain number of patients experience glare, a “starbursting” or halo effect around lights, or other low-light vision problems that may interfere with the ability to drive at night or see well in dim light. The exact cause of these visual problems is not currently known; some ophthalmologists theorize that the risk may be increased in patients with large pupils or high degrees of correction. For most patients, this is a temporary condition that diminishes with time or is correctable by wearing glasses at night or taking eye drops. For some patients, however, these visual problems are permanent. Retreatment often improves night glare by reducing the residual refractive problems, but it is limited by the remaining corneal thickness, treatment area, individual patient sensitivity to night glare, and corneal healing pattern. I understand that my vision may not seem as sharp at night as during the day and that I may need to wear glasses at night or take eye drops. I understand that it is not possible to predict whether I will experience these night vision or low light problems, and that I may permanently lose the ability to drive at night or function in dim light because of them. I understand that I should not drive unless my vision is adequate.
6. Some patients develop keratoconus, a degenerative corneal disease affecting vision that occurs in approximately 1/2000 in the general population. While there are several tests that suggest which patients might be at risk, this condition can develop in patients who have normal preoperative topography (a map of the cornea obtained before surgery) and pachymetry (corneal thickness measurement) . Since keratoconus may occur on its own, there is no absolute test that will ensure a patient will not develop keratoconus following laser vision correction. Severe keratoconus may need to be treated with a corneal transplant while mild keratoconus can be corrected by glasses or contact lenses.
REFRACTIVE COMPLICATIONS
1. Repeat LASIK may result in overcorrection and undercorrection 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 glasses or contact lenses or undergo additional surgery. Further surgery entails additional risk and is not guaranteed to provide an ideal visual income, although improvement is often obtained.
2. Patients may heal differently between eyes based upon differences in preoperative prescriptions, corneal curvature, variation in healing, or other factors. Differences in refraction between eyes is called anisometropia. This is most severe when only one eye is treated, and may result in 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 the eye to wander more, or producing eye fatigue.
3. Depending upon the severity of the original prescription, the healing pattern of the patient, and other factors, regression may occur, causing the eyes to return to their original prescription, either partially or completely. Further retreatment surgery may be performed when the eye is stable and if adequate corneal tissue is available and no medical contraindications exist.
CORNEAL FLAP COMPLICATIONS
1. The most severe flap complication is a corneal perforation, which requires corneal stitches or sutures, and usually the need for an intraocular lens implant as the natural lens is usually lost or damaged. Corneal perforation could also lead to infection, the need for a corneal transplant, or even blindness.
2. When repeat LASIK is performed by lifting the original flap, the risk associated with the flap creation are avoided, although other risks remain. Corneal flap complications that occur after the LASIK procedure during the recovery period, such as displacement and wrinkling of the flap and epithelial ingrowth, may occur whether lifting the original flap or creating a new one.
3. Partial or complete corneal flap displacement may occur either during the early postoperative period or days to weeks later after trauma. Care should be taken to protect the eye from trauma, and you should not rub your eyes or forcefully close them during the first week after repeat LASIK. Partial displacement of the corneal flap may result in corneal striae or wrinkles, which blur vision. Most striae are treatable, but some patients, such as those who are highly nearsighted, may be resistant to treatment. Complete displacement of the corneal flap is often painful and requires urgent replacement. There is a higher risk of epithelial ingrowth and infection with complete flap displacement.
4. Epithelial ingrowth occurs during the first month after LASIK and is more likely to occur in patients with an abnormal or weakly adherent protective layer, for which age is a risk 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, so it is more common in LASIK retreatment procedures that lift the original corneal flap. Treatment of this condition involves lifting the flap and clearing away the cells. Although most small areas of epithelial ingrowth only need to be monitored and do not cause visual problems, untreated larger areas may distort vision and may actually damage the flap integrity if severe and progressive.
CORNEAL HEALING COMPLICATIONS
The protective corneal flap of LASIK reduces the healing component of LASIK compared to PRK, but significant healing is still required, which can affect visual quality and ability. Corneal healing problems are more common in patients corrected for higher prescriptions for over- and undercorrection.
Corneal healing may affect not only the speed of healing but the smoothness of the cornea, leading to blurry vision or rarely corneal scarring. Corneal irregularities may develop that affect the quality, crispness, and sharpness of the final result. Corneal irregularity or corneal astigmatism is produced when the cornea heals in an irregular pattern, which may or may not follow a surgical flap complication. It may also be produced by abnormalities and complications of the laser treatment, including central islands and decentrations. These are expected during the first few weeks following an uncomplicated repeat LASIK, but if they persist beyond 3-6 months, they are considered abnormal and permanent. Further surgical intervention does not guarantee better healing and may 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 you may be unable to read the bottom few lines of an eye chart even with glasses or contact lenses. The best vision you may experience after surgery, even with lens correction, may not be as good as before refractive surgery.
In some cases, vision may be severely impaired and affect your ability to drive legally, especially if you already have reduced vision from other causes. LASIK is not intended to improve visual potential, and many patients with high prescriptions often are unable to read 20/20 before surgery and should not expect to read 20/20 after surgery. A patient who is best corrected before surgery to 20/40 is already borderline for driving legally and any loss of best corrected vision from healing or surgical complications may prevent legal driving.
In general, healing after repeat LASIK is usually more rapid, but may follow the same course as the original LASIK healing pattern. The speed of the original healing pattern is usually based upon the severity of the original prescription and is typically slowest for patients treated for high degrees of farsightedness.
EXPECTATIONS
The goal of repeat LASIK is to achieve the best visual result with the safest method while dramatically reducing dependency on glasses or contacts. As examples, night driving glasses and reading glasses may still be needed. The degree of correction required determines both the rate of recovery and the initial accuracy of the procedure. Severe degrees of nearsightedness may require two procedures. Patient differences in healing can also greatly affect visual recovery and final visual outcome and are impossible to predict. After the initial procedure and even if further procedures are performed, you may have some remaining nearsightedness, farsightedness, or astigmatism, If so, glasses and/or contact lenses may still be needed some or all of the time.
VOLUNTARY CONSENT
By signing this Informed Consent Form, I certify that I have read the preceding information and understand the contents. The potential advantages and disadvantages have been reviewed with
me. Any questions I have concerning this consent form have been fully answered. I fully
understand the possible risks, complications, and benefits that can result from repeat LASIK. I consent to repeat LASIK on my ______________ (state “right” or “left”) eye.
_______________________________ __________________
Patient Signature Date
STATEMENT:
I give permission for my ophthalmologist to record on video or photographic equipment my procedure, for purpose of education, research, or training of other health care professionals. I also give permission for my ophthalmologist to use data about my procedure and subsequent treatment to further understand LASIK. I understand that my name will remain confidential, unless I give subsequent written permission for it to be disclosed outside my ophthalmologist’s office or the center where my LASIK procedure will be performed.
Patient Initials: ______________
LASIK Retreatment Consent
SAVE THIS FORM TO YOUR COMPUTER BY USING THE DOWNLOAD BUTTON. A PREVIEW IS DISPLAYED BELOW.
PLACE LETTERHEAD HERE AND REMOVE NOTE.
CHANGE FONT SIZE FOR LARGE PRINT
NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT. Version 7/19/06
Consent for LASIK (Laser In Situ Keratomileusis) Retreatment
INTRODUCTION
It is our hope to fully inform you about the indications, side effects, limitations, and complications of repeat LASIK surgery, or retreatment. This consent form in combination with the 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. It is important to realize that even if you did not experience any difficulties with your original LASIK procedure, that does not mean that you will not have any complications with the retreatment. The only way in which a patient can avoid all surgical risks is by not proceeding with surgery. Each patient must balance the risks and benefits to determine whether to proceed with further surgery.
INDICATIONS AND ALTERNATIVES
As you were informed before your first LASIK procedure, retreatments are at times indicated to correct remaining or induced myopia (nearsightedness), hyperopia (farsightedness), and astigmatism. There is no guarantee that repeat LASIK will correct these problems. Alternative forms of vision correction exist, including eyeglasses, contact lenses, orthokeratology (ortho-K), radial keratotomy (RK), intracorneal ring segments (ICRS), holmium laser thermokeratoplasty (LTK), or photorefractive keratectomy (PRK).
ELIGIBILITY FOR RETREATMENTS
The ophthalmologist alone can determine whether or not you are a candidate for retreatment. Several factors determine eligibility. LASIK retreatment procedures are performed by lifting the corneal flap and applying additional laser to the corneal bed, or by repeating the original LASIK procedure and creating a new corneal flap. Eligibility and the choice of technique are determined primarily by the amount of time that has passed since the original corneal flap was created, the amount of corneal flap healing that has taken place, and the corneal thickness. An enhancement can be performed once the vision and prescription (refraction) stabilize after the original LASIK procedure, which takes between one to four months for most patients. Typically, the higher the attempted correction for the original procedure, the longer it takes for the cornea to heal. Many surgeons wait three months before retreating any patient, others treat those with low prescriptions after one to two months. The corneal flap can usually be easily lifted during the first two years, and in many cases, it can even be lifted after several years. Sometimes, however, even after a few months, the corneal flap is sealed and cannot be lifted again. If the flap cannot be lifted, the surgeon and patient must decide either to abandon the surgery, apply the laser correction to the surface (PRK), or create a new flap. Creating a new flap in an eye with an existing flap is considered by many surgeons to be a more risky option and should be approached with caution. The ideal time for a retreatment is when the refraction is
stable. There must be adequate corneal tissue under the flap to safely perform the reoperation and this can be measured at the time of the surgery. The remaining corneal thickness is an important factor the surgeon considers when deciding whether a retreatment can be safely performed.
ADVANTAGES AND DISADVANTAGES OF ORIGINAL VERSUS NEW FLAP
Surgeon experience, patient preference, and corneal measurements determine the type of technique. The advantages of lifting the original corneal flap are related to safety, because no additional incision is required and the surgical risks associated with the creation of the corneal flap are avoided. The disadvantages are that the procedure is often more uncomfortable postoperatively for the first several hours, and the corneal flap edges must re-heal. The risk of epithelial ingrowth may be increased when the flap is lifted. If this occurs, additional surgery may be required to remedy the problem. As stated above, depending upon the healing of the original flap, it may or may not be possible to lift the flap. Occasionally, the flap can only be partially lifted; if this happens, the retreatment must be cancelled for several months while the flap re-heals before making another incision.
The advantage of creating a new flap is that the procedure is much the same as the original procedure and many patients find it easier as they know what to expect. The most serious concern with creating a new corneal flap is that inadequate healing of the original flap may result in a free or loose piece of corneal tissue being formed. That is, while creating the new flap, a separate, small wedge of the original corneal flap tissue is produced either in the center or on the side of the flap. This wedge of tissue can make the center of the cornea irregular or cause scarring on the side that could lead to epithelial ingrowth, both of which can compromise vision.
During the re-treatment procedure, after the original flap is lifted, or after the microkeratome or IntraLase laser cuts a new flap, the flap is flipped over out of the way, and the laser application is performed within the corneal bed instead of on the corneal surface as with PRK. The flap is replaced immediately following the laser application. The flap is held in position through an almost immediate suction-type action within the cornea and by the protective layer of the cornea called the epithelial layer, which rapidly envelopes the surface within days. In most cases no stitch is required. If a stitch is required, it is below the surface and usually removed within several days. A soft contact lens may be applied as a bandage to protect the surface for the first day or so. Often, the surgeon may choose to perform the retreatment on the surface of the cornea without lifting the flap. This option is usually chosen to enhance the safety of the retreatment and to provide the best quality of vision.
COMPLICATIONS
The risks associated with the original LASIK procedure apply to retreatment as well. It is not possible to list every complication. Some risks and complications may not be known, including long-term risks. The most severe complications would require more invasive or repeated corneal surgery, including corneal transplantation, and could potentially cause partial or complete loss of vision.
POSTOPERATIVE SIDE EFFECTS AND COMPLICATIONS
1. Early in the postoperative period, you may experience a foreign body sensation, pain or discomfort, sensitivity to bright lights, blurred vision, dry eyes, tearing, or fluctuations in vision. Discomfort is more common during the first few hours after surgery with retreatment than with the original LASIK procedure. Persistent pain is uncommon, and may indicate a disturbance of the epithelial protective layer, displacement of the corneal flap, or a possible infection. You should immediately notify the surgeon if you have persistent pain.
2. Corneal infection following LASIK enhancement is rare but if serious can cause corneal scarring and require a corneal transplant. In very severe cases, blindness can result.
3. Corneal inflammation can be caused by medications or healing reactions which can be allergic, toxic, or immune in nature. Diffuse interface keratitis (also known as the Sands of the Sahara) may occur with both primary and repeat LASIK. This inflammatory reaction can cause corneal haze, blurred vision, farsightedness, astigmatism, or permanent corneal irregularities. Treatment may involve topical steroids or further surgery, and treatment may or may not fully restore vision.
4. I understand that there is an increased risk of eye irritation related to drying of the corneal surface following the LASIK procedure. These symptoms may be temporary or, on rare occasions, permanent, and may require frequent application of artificial tears and/or closure of the tear duct openings in the eyelid.
5. After refractive surgery, a certain number of patients experience glare, a “starbursting” or halo effect around lights, or other low-light vision problems that may interfere with the ability to drive at night or see well in dim light. The exact cause of these visual problems is not currently known; some ophthalmologists theorize that the risk may be increased in patients with large pupils or high degrees of correction. For most patients, this is a temporary condition that diminishes with time or is correctable by wearing glasses at night or taking eye drops. For some patients, however, these visual problems are permanent. Retreatment often improves night glare by reducing the residual refractive problems, but it is limited by the remaining corneal thickness, treatment area, individual patient sensitivity to night glare, and corneal healing pattern. I understand that my vision may not seem as sharp at night as during the day and that I may need to wear glasses at night or take eye drops. I understand that it is not possible to predict whether I will experience these night vision or low light problems, and that I may permanently lose the ability to drive at night or function in dim light because of them. I understand that I should not drive unless my vision is adequate.
6. Some patients develop keratoconus, a degenerative corneal disease affecting vision that occurs in approximately 1/2000 in the general population. While there are several tests that suggest which patients might be at risk, this condition can develop in patients who have normal preoperative topography (a map of the cornea obtained before surgery) and pachymetry (corneal thickness measurement) . Since keratoconus may occur on its own, there is no absolute test that will ensure a patient will not develop keratoconus following laser vision correction. Severe keratoconus may need to be treated with a corneal transplant while mild keratoconus can be corrected by glasses or contact lenses.
REFRACTIVE COMPLICATIONS
1. Repeat LASIK may result in overcorrection and undercorrection 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 glasses or contact lenses or undergo additional surgery. Further surgery entails additional risk and is not guaranteed to provide an ideal visual outcome, although improvement is often obtained.
2. Patients may heal differently between eyes based upon differences in preoperative prescriptions, corneal curvature, variation in healing, or other factors. Differences in refraction between eyes is called anisometropia. This is most severe when only one eye is treated, and may result in 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 the eye to wander more or producing eye fatigue.
3. Depending upon the severity of the original prescription, the healing pattern of the patient, and other factors, regression may occur, causing the eyes to return to their original prescription, either partially or completely. Further retreatment surgery may be performed when the eye is stable and if adequate corneal tissue is available and no medical contraindications exist.
CORNEAL FLAP COMPLICATIONS
1. The most severe flap complication is a corneal perforation, which requires corneal stitches or sutures, and usually the need for an intraocular lens implant as the natural lens is usually lost or damaged. Corneal perforation could also lead to infection, the need for a corneal transplant, or even blindness.
2. When repeat LASIK is performed by lifting the original flap, the risk associated with the flap creation are avoided, although other risks remain. Corneal flap complications that occur after the LASIK procedure during the recovery period, such as displacement and wrinkling of the flap and epithelial ingrowth, may occur whether lifting the original flap or creating a new one.
3. The most serious concern with creating a new corneal flap is that inadequate healing of the original flap may result in a free or separate piece of corneal tissue being formed. This wedge of tissue can make the center of the cornea irregular or cause scarring on the side that could lead to epithelial ingrowth, both of which can compromise vision.
4. Partial or complete corneal flap displacement may occur either during the early postoperative period or days to weeks later after trauma. Care should be taken to protect the eye from trauma, and you should not rub your eyes or forcefully close them during the first week after repeat LASIK. Partial displacement of the corneal flap may result in corneal striae or wrinkles, which blur vision. Most striae are treatable, but some patients, such as those who are highly nearsighted, may be resistant to treatment. Complete displacement of the corneal flap is often painful and requires urgent replacement. There is a higher risk of epithelial ingrowth and infection with complete flap displacement.
5. Epithelial ingrowth occurs during the first month after LASIK and is more likely to occur in patients with an abnormal or weakly adherent protective layer, for which age is a risk 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, so it is more common in LASIK retreatment procedures that lift the original corneal flap. Treatment of this condition involves lifting the flap and clearing away the cells. Although most small areas of epithelial ingrowth only need to be monitored and do not cause visual problems, untreated larger areas may distort vision and may actually damage the flap integrity if severe and progressive.
CORNEAL HEALING COMPLICATIONS
The protective corneal flap of LASIK reduces the healing component of LASIK compared to PRK, but significant healing is still required, which can affect visual quality and ability. Corneal healing problems are more common in patients corrected for higher prescriptions for over- and undercorrection.
Corneal healing may affect not only the speed of healing but the smoothness of the cornea, leading to blurry vision or rarely corneal scarring. Corneal irregularities may develop that affect the quality, crispness, and sharpness of the final result. Corneal irregularity or corneal astigmatism is produced when the cornea heals in an irregular pattern, which may or may not follow a surgical flap complication. It may also be produced by abnormalities and complications of the laser treatment, including central islands and decentrations. These are expected during the first few weeks following an uncomplicated repeat LASIK, but if they persist beyond 3-6 months, they are considered abnormal and permanent. Further surgical intervention does not guarantee better healing and may 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 you may be unable to read the bottom few lines of an eye chart even with glasses or contact lenses. The best vision you may experience after surgery, even with lens correction, may not be as good as before refractive surgery.
In some cases, vision may be severely impaired and affect your ability to drive legally, especially if you already have reduced vision from other causes. LASIK is not intended to improve visual potential, and many patients with high prescriptions often are unable to read 20/20 before surgery and should not expect to read 20/20 after surgery. A patient who is best corrected before surgery to 20/40 is already borderline for driving legally and any loss of best corrected vision from healing or surgical complications may prevent legal driving.
In general, healing after repeat LASIK is usually more rapid, but may follow the same course as the original LASIK healing pattern. The speed of the original healing pattern is usually based upon the severity of the original prescription and is typically slowest for patients treated for high degrees of farsightedness.
EXPECTATIONS
The goal of repeat LASIK is to achieve the best visual result with the safest method while dramatically reducing dependency on glasses or contacts. As examples, night driving glasses and reading glasses may still be needed. The degree of correction required determines both the rate of recovery and the initial accuracy of the procedure. Severe degrees of nearsightedness may require two procedures. Patient differences in healing can also greatly affect visual recovery and final visual outcome and are impossible to predict. After the initial procedure and even if further procedures are performed, you may have some remaining nearsightedness, farsightedness, or astigmatism, If so, glasses and/or contact lenses may still be needed some or all of the time.
VOLUNTARY CONSENT
By signing this Informed Consent Form, I certify that I have read the preceding information and understand the contents. The potential advantages and disadvantages have been reviewed with
me. Any questions I have concerning this consent form have been fully answered. I fully
understand the possible risks, complications, and benefits that can result from repeat LASIK. I consent to repeat LASIK on my ______________ (state “right” or “left”) eye.
_______________________________ __________________
Patient Signature Date
STATEMENT:
I give permission for my ophthalmologist to record on video or photographic equipment my procedure, for purpose of education, research, or training of other health care professionals. I also give permission for my ophthalmologist to use data about my procedure and subsequent treatment to further understand LASIK. I understand that my name will remain confidential, unless I give subsequent written permission for it to be disclosed outside my ophthalmologist’s office or the center where my LASIK procedure will be performed.
Patient Initials: ______________
LASIK. Bilateral Simultaneous
SAVE THIS FORM TO YOUR COMPUTER BY USING THE DOWNLOAD BUTTON. A PREVIEW IS DISPLAYED BELOW.
PLACE LETTERHEAD HERE AND REMOVE NOTE.
CHANGE FONT SIZE FOR LARGE PRINT
NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.
Version 11/01/06
Addendum: Consent for Bilateral Simultaneous LASIK
LASIK has become a common procedure for many refractive surgery patients. While many patients choose to have both eyes treated at the same surgical setting, there may be risks associated with simultaneous treatment that are not present when the eyes are treated on different days. 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.
Safety: The risks of infection, severe inflammation, delayed clouding of the cornea, corneal scarring and internal bleeding or retinal damage are very rare but potentially devastating. If these complications occur in one eye, they may also occur in the other. Should any of these complications happen, you could experience significant loss of vision or even temporary or permanent legal blindness. By choosing to have LASIK performed on separate days, you avoid the risk of having one or more of these complications in both eyes at the same time.
Accuracy: If there is an over-correction or under-correction in one eye, chances are it may happen in both eyes. If a retreatment is required in one eye, it is quite possible that your fellow eye may also require a retreatment. By having surgery on separate days, 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. In some patients, this might improve the accuracy of the result in the second eye. By correcting both eyes simultaneously, there is no opportunity to learn from the healing patterns of the first eye before treating the second eye.
Visual Recovery: Most LASIK patients experience rapid visual recovery, but some may experience symptoms such as blurred vision, night glare or ghost images that can result in prolonged recovery of normal vision. Blurred vision may rarely continue for several weeks, which could make driving difficult or dangerous and could interfere with your ability to work if it occurs in both eyes. There is no way of predicting how long your eyes will take to heal. If the eyes are operated separately, you can generally function with the fellow eye while the first eye fully recovers. However, there may be a period of imbalance in vision between your two eyes, producing a form of double vision. If you are able to wear a contact lens in your unoperated eye, the corrective lens could minimize this imbalance. The balance in vision between your two eyes will usually be restored more rapidly if they are operated on the same day.
The healing corneal flap is most susceptible to trauma during the first several weeks after surgery. Should both flaps become accidentally displaced, significant visual loss 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 will likely experience them in both eyes. These side effects may cause a decrease in vision or other negative effects, and some patients have elected to not have their second eye treated. By having each eye treated on separate dates, you will have the opportunity to determine whether the LASIK procedure has produced satisfactory visual results without loss of vision or other uncommon undesirable side effects. If you are over age 40, you will also have an opportunity to experience the change in your close vision that results from the correction of your nearsightedness or farsightedness. This could influence your decision on whether or not to fully correct your other eye to maintain some degree of close vision without the need for glasses (monovision).
Convenience: It may be inconvenient for you to have each eye treated at separate visits because it would necessitate two periods of recovery from the laser surgery and might require additional time away from work.
Cost: Professional and facility fees may be greater if the eyes are operated on different days, and the additional time off work that may also be needed can be costly.
Consent Statement:
“I have read and understand the above risks and benefits of bilateral simultaneous LASIK, and I understand that this summary does not include every possible risk, benefit and complication that can result from bilateral simultaneous LASIK. My doctor has answered all of my questions about the LASIK procedure. I wish to have both of my eyes treated during the same treatment session if my doctor determines that the treatment in the first eye appeared to be technically satisfactory.
The reason(s) I wish to have both eyes treated at the same time are:
Greater convenience
Possible faster recovery
Less time away from work
Contact lens intolerance and/or difficulty wearing contacts
Elimination of possible vision imbalance between treated and untreated eyes
Other:
Patient signature Date
Witness Date
Intacs: Consent for Off-Label Therapeutic Use for Post-LASIK Ectasia
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NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.
Version 11/01/06
Consent for Off- for Therapeutic Use
Of Intacs® for Post-LASIK Ectasia
This information is to help you make an informed decision about having Intacs® inserted in your eye to reduce the myopia (nearsightedness) and astigmatism that has developed after LASIK surgery due to a condition called ectasia . Ectasia is an abnormal bulging forward of the cornea, the clear front part of the eye that covers, the iris and pupil. Every surgery has risks as well as benefits and each person must evaluate this risk/benefit ratio based on the information given to you, as well as the conversations with your physician and staff. You are encouraged to ask any questions about this procedure and have them answered to your satisfaction before you give your permission for this surgery.
Indications and Benefits of Intacs® Used “Off-Label” To Treat Ectasia
Intacs® are intrastromal corneal ring segments available through Addition Technology, Inc. The ophthalmologist inserts one or two small transparent half-rings into the peripheral cornea through a tiny incision. Intacs® are approved by the Food and Drug Administration (FDA) to treat myopia. When the FDA approves a drug or device for medical use, the manufacturer produces a “label” to explain its use. Once a device or medication is approved by the FDA, physicians may use it “off-label” for other purposes if they are well-informed about the product, base its use on firm scientific method and sound medical evidence, and maintain records of its use and effects.
Although initially approved for elective refractive surgery, ophthalmologists use Intacs® “off-label” as a therapeutic treatment for the myopia and astigmatism that accompanies post-LASIK ectasia. Intacs® do not provide a full correction or a full reversal back to your eye’s normal state. Rather, the goal is to reduce your myopia and astigmatism and /or alter the shape of your cornea so that you can be fitted for contact lenses. Intacs® can be removed and replaced if the results are not satisfactory, or if you want to have them removed.
Alternative Treatment for Post-Refractive Surgery Ectasia
Instead of having the ophthalmologist insert Intacs®, you could have a full thickness corneal transplant. A corneal transplant procedure is not reversible. Your own cornea might reject the transplant or it could also develop a postoperative infection; these complications could compromise your vision.
Possible Risks of Inserting Intacs®
The goal of inserting Intacs® is to reduce your myopia and astigmatism and /or alter the shape of your cornea so that you can be fitted for contact lenses. As with any surgical procedure, there are certain risks and complications you need to be aware of when considering Intacs®. As a result of the surgery and associated anesthesia, it is possible that your vision could be made worse. In some cases, complications may occur weeks, months or even years later. These and other complications may result in poor vision, total loss of vision, or even loss of the eye in rare situations. Although all of these complications can occur, their incidence following Intacs® surgery is low.
Risks of Intacs® surgery include, but are not limited to:
• Discomfort and/or pain for up to 48 hours following the procedure, which can be treated with medication
• Blurred vision, fluctuating vision, or tearing
• Sensitivity to bright light or glare
• Astigmatism (a temporary blurring or distortion of your vision) for several days after the procedure. This type of visual distortion is normal during the healing process and, in most cases, it decreases overtime. However, in rare instances, it may be permanent.
• Infection, which if severe could result in the loss of the eye
• Corneal edema
• Corneal perforation, which could lead to infection, or, rarely, a cataract
• Decrease in best-corrected visual acuity
• Other procedures may be required to reach the desired result. While there is no guarantee that the goal will be reached with an additional procedure, uncorrected vision may improve.
• Stromal thinning due to shallow placement, which would require removal of the Intacs®
• If there are complications or problems during the surgery, the surgeon may not be able to insert Intacs®, and the surgery may have to be cancelled.
• Complications due to the anesthetic eye drops are possible.
• Certain patients have reported continued visual distortion related to Intacs®. The US Studies conducted to obtain FDA approval for myopia showed that the following potential vision-threatening events happened less than 1% of the time after Intacs®. All patients returned to the vision they had prior to the procedure. Some experienced infection (0.2%), and others had stromal thinning due to shallow placement (0.2%).
o These studies were NOT conducted on patients with post-LASIK ectasia, and the risks for patients with ectasia may be higher.
• Intacs® will NOT prevent the development of naturally occurring eye problems such as glaucoma, cataracts, retinal degeneration, or detachment.
• Intacs® do NOT correct the condition known as presbyopia (or aging of the eye), which may require reading glasses for close-up work at about age 40.
• There are other risks associated with any surgery. Since it is impossible to state every risk or complication that may occur as a result of any surgery, the possible risks and complications listed in this informed consent may be incomplete. There may be risks or complications associated with this surgery that are unknown because this is a relatively new procedure.
Patient Responsibilities
• I have arranged for transportation after the procedure and to my next appointment. I understand that my doctor will advise me when I can safely resume driving.
• I accept full personal financial responsibility for payment of all fees related to my Intacs® . These include the procedure itself, necessary medications, eyeglasses required after the procedure, and expenses connected with my travel to and from the surgery site or office.
• I understand and am acknowledging my willingness to follow the doctor’s instructions and attend regular postoperative visits to reduce the risk of long-term complications.
Patient initials _______
PATIENT CONSENT
During Intacs® surgery, my ophthalmologist will insert one or two small transparent half-rings into the peripheral cornea of my eye through a tiny incision. The surgery is intended to be permanent, but the Intacs® can be removed if necessary. My surgeon has explained the basic procedures of Intacs® surgery, as well as the risks, benefits, and alternative treatments. I have been given a copy of “Patient Booklet: Facts You Need to Know About ® INTACS® ™ for Nearsightedness” and have discussed it with my doctor. Although it is impossible for the doctor to inform me of every possible complication that may occur, the doctor has answered all my questions to my satisfaction.
• I understand that Intacs® were approved by the FDA for myopia and keratoconus; they have not been approved for post-LASIK ectasia. Nevertheless, I wish to have Intacs® placed into my cornea, and I am willing to accept the potential risks that my physician has discussed with me. __________ (Patient initials)
• In signing this informed consent for the insertion of Intacs®, I am stating that I have been offered a copy, I fully understand the possible risks, benefits, and complications of Intacs® surgery and:
o I have read this informed consent _________ (Patient initials)
o The consent form was read to me by _______________________________ (name).
• I wish to have Intacs® inserted in my _________ (state “right” or “left”) eye.
Patient (or person authorized to sign for patient) Date
I give the surgeon permission to:
• Record my procedure on video or photographic equipment for purposes of education, research or the training of other health care professionals. _______ Patient initials
• Use the data about my procedure in subsequent procedures without reference to my name, to further the understanding of refractive surgery. _______ Patient initials
