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Conductive Keratoplasty. Bilateral Simultaneous CK for Hyeropia

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Addendum: Consent for Bilateral Simultaneous CK for Treatment of Hyperopia

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 risk of infection and other healing complications is applicable to both eyes simultaneously. Therefore, if an infection occurs in one eye, it may also occur in the other eye. Although rare, a serious infection in both eyes can cause significant loss of vision and even legal blindness. By choosing to have CK performed on separate days, you will 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 if necessary. In some patients, this may 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: Some patients may experience symptoms such as blurred vision, night glare or ghost images that can delay recovery of normal vision. Blurred vision may 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 your fellow eye while the first eye is healing. However, there may be a period of imbalance in vision between your 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 may be restored more rapidly if they are operated on the same day.

Satisfaction: Both eyes tend to experience similar side effects. If you experience undesirable side effects such as pain, 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 CK procedure has produced satisfactory visual results without loss of vision or other undesirable side effects.

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 can be costly.

____________
Initial

Consent Statement:

“I have read and understand the above risks and benefits of bilateral simultaneous CK for treatment of hyperopia, and I understand that this summary does not include every possible risk, benefit and complication that can result from bilateral simultaneous CK. My doctor has answered all of my questions about the CK 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

Conductive Keratoplasty NearVisionSM CK

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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 06/30/05

INFORMED CONSENT FOR NEARVISIONSM CK®  (CONDUCTIVE KERATOPLASTY®)

Introduction
Vision-correcting surgery such as Conductive Keratoplasty, LASIK and PRK can precisely and accurately correct fixed focal errors of the eye such as farsightedness, nearsightedness, and astigmatism. These optical conditions are fundamentally different than presbyopia, the loss of adjustability of focus for near viewing. Presbyopia is the reason that reading glasses become necessary, typically in the age range of mid-40, even for people who have excellent unaided distance vision. For those that require prescriptive correction to see clearly at distance, bifocals or separate (different prescription) reading glasses become necessary at that age to see clearly at close range.

This information and the Patient Information booklet are being provided to you so that you can make an informed decision about the use of a device known as the ViewPoint™ CK System, which is utilized to perform the NearVision CK procedure. NearVision CK is one of a number of alternatives for correcting your vision. The NearVision CK procedure uses a controlled release of radiofrequency (RF) energy to increase the temperature of corneal tissue. The treatment is applied with a probe that is introduced 16 to 24 times into the cornea in a circular pattern, which results in an increased curvature of the cornea to treat your vision. The correction you achieve with NearVision CK may be temporary.

NearVision CK is an elective procedure. There is no emergency condition or other reason that requires or demands that you have it performed. You could continue wearing contact lenses or glasses and have adequate visual acuity. This procedure, like all surgery, presents some risks, many of which are listed below. You should also understand that there might be other risks not known to your doctor, which may become known later. Despite the best of care, complications and side effects may occur; should this happen in your case, the result might be affected even to the extent of making your vision worse.

Alternatives to NearVision CK
There are several options available to those who are presbyopic, besides wearing bifocals or separate reading glasses. For example, for some individuals, wearing a contact lens in one eye for distance vision, and a contact lens in the other eye for reading, affords a reasonable solution. This is called monovision (mono for one; one eye for distance, one eye for near vision).

If a person enjoys and functions well with monovision in contact lenses, the same option can be created on a more permanent basis with vision-correcting surgery such as NearVision CK. If you are contemplating such correction for yourself, it is important to understand the advantages and drawbacks of such care.

If you decide not to have NearVision CK, alterative methods of correcting your vision include, among others, eyeglasses, contact lenses, and other refractive surgical procedures.

Patient Initials
NEARVISIONSM CK® INFORMED CONSENT
PAGE 2

Patient Consent
At this time, there is no perfect treatment or cure for presbyopia. The typical solutions described above are all to some extent a compromise of one form or another. For many people, wearing reading glasses for near vision correction is troublesome enough, and wearing bifocals is even less pleasant.

In giving my permission for NearVision CK, I understand the following: the long-term risks and effects of NEARVISION CK are unknown. I have received no guarantee as to the success of my particular case. I understand that the following risks are associated with the procedure:

Vision Threatening Complications
I understand that it is possible that scarring, ulceration, or an eye infection that could not be controlled with antibiotics or other means could also cause damage to my cornea.

Non-vision Threatening Side Effects
1) I understand that I may experience a reduction in my depth perception. For most people, depth perception is best when viewing with both eyes optimally corrected and “balanced” for near and distance. Eye care professionals refer to this as binocular vision. Monovision can impair depth perception to some extent, because the eyes are not focused together at the same distance. Because monovision can reduce optimum depth perception, it is important that you complete a successful trial of monovision or have a history of monovision wear using glasses or contact lens prior to contemplating a surgical correction.
2) I understand that ocular dominance and choosing the ‘near’ eye correctly is important when considering monovision. Tests can be performed to determine which eye, right or left, is dominant, or preferred eye for viewing, in a particular person. Conventional wisdom holds that if contemplating monovision, the non-dominant eye is corrected for near, and the dominant eye should be maintained or corrected for distance; the FDA approved CK for presbyopia under these conditions. While correcting the non-dominant eye for near is a guideline, it should not be construed as an absolute rule. A very small percentage of persons may be co-dominant (similar to being ambidextrous), and in rare circumstances a person may actually prefer using the dominant eye for near viewing. The methods for testing and determining ocular dominance are not always 100% accurate; there is some subjective component in the measurement process; and different eye doctors may use slightly different methods of testing. It is critical to determine through use of glasses or contact lenses which combination is best for each person prior to undertaking any surgical intervention. Be sure you understand this and have discussed with your surgeon which eye should be corrected for near, and if applicable, which eye for distance. If you have any doubts or uncertainty, surgery should be delayed until a solid comfort level is attained through use of monovision contact lenses. Under no circumstances should you consider undertaking monovision surgical correction before you are convinced it will be right for you. Once surgery is performed, it is not always possible to undo what is done, or to reverse the near and distance eye without some loss of visual quality.

Patient Initials
NEARVISIONSM CK® INFORMED CONSENT
PAGE 3

3)   I understand that visual acuity I initially gain from NearVision CK could regress, and that my vision could go partially or completely back to the level it was immediately prior to having the procedure.
4)   I understand that I may not get a full correction from NearVision CK and that I may require future enhancement procedures or the use of glasses or contact lenses. This procedure may also cause an increase in my astigmatism, which may cause blurred vision.
5)   I understand that an overcorrection could occur, causing me to become nearsighted, and that his nearsightedness could be either permanent or treatable.
6)   I understand that the correction that I can expect to gain from NearVision CK may not be perfect and it is not realistic to expect that this procedure will result in perfect vision, at all times, under all circumstances, for the rest of my life. I understand I may need glasses to refine my vision for some purpose requiring fine detailed vision after some point in my life, and that this might occur soon after surgery or years later.
7)   I understand that there may be pain, scratchiness, a foreign body sensation, or slight dryness in my eye, particularly during the first 48 hours after surgery.
8)   I understand that there may be increased sensitivity to light, and that I may experience glare and halos around lights. I understand this condition usually resolves within the first few weeks following treatment, but it also may be permanent.
9)   I understand that there may be a “balance” problem between my two eyes after NearVision CK has been performed on one eye, but not the other. This phenomenon is called anisometropia. I understand that my first eye may take longer to heal than is usual, prolonging the time I could experience anisometropia.
10)   I understand I may temporarily experience corneal haze, small round hazy areas where the cornea was heated during the NearVision CK treatment. This haze will usually fade over time and may only be visible with a microscope within 3 months following surgery.
11)   I understand that there is a natural tendency for the eyelids to droop with age and that eye surgery may hasten this process.
12)   I understand that I may be given medication in conjunction with the procedure. I understand that I must not drive for at least one day following the procedure and until I am certain that my vision is adequate for driving.
13)   I understand that the follow-up effects of NearVision CK are unknown, and that NearVision CK has not been in use long enough to measure long-term effects (those occurring after 10 years or more) following the procedures, and that unforeseen complications or side effects could occur.
14)   I understand that NearVision CK will not prevent me from developing naturally occurring eye problems, such as glaucoma, cataracts, retinal degeneration or retinal detachment.
15)   I understand that, as with all types of surgery, there is a possibility of complications due to anesthesia, drug reactions, or other factors that involve other parts of my body. I understand that, since it is impossible to state every complication that may occur as a result of surgery, the list of complications in this form may not be complete.

Patient Initials
NEARVISIONSM CK® INFORMED CONSENT
PAGE 4

Patient Statement of Acceptance and Understanding
I have read and understand the information in the Patient Information booklet that has been provided to me. The details of the procedure known as NearVision CK have been presented to me in this document and explained to me by my ophthalmologist. My ophthalmologist has answered all my questions to my satisfaction. I therefore consent to NearVision CK surgery.

I give permission to my ophthalmologist to record on video or photographic equipment my procedure, for purposes of education, research, or training of other healthcare professionals. I also give my permission for my ophthalmologist to use data about my procedure and subsequent treatment to further understand NearVision CK. 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 NearVision CK procedure will be performed.

I have had a successful trial of monovision or have a history of monovision wear using glasses or contact lens. __________ (please initial).

I consent to having my ___________ (indicate “right” or “left”) eye corrected for near vision.

Patient Signature Date

Witness Signature Date

I have been offered a copy of this consent form (please initial)

Conductive Keratoplasty (CK) for Hyperopia

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INFORMED CONSENT FOR CONDUCTIVE KERATOPLASTY (CK) FOR THE CORRECTION OF HYPEROPIA (FARSIGHTEDNESS)

INTRODUCTION

This information and the Patient Information booklet are being provided to you so that you can make an informed decision about the use of a device known as the Viewpoint CK System, to perform CK. CK is one of a number of alternatives for correcting farsightedness. The CK treatment utilizes a controlled release of radiofrequency (RF) energy to increase the temperature of corneal tissue. The treatment is applied with a probe that is introduced 8 to 32 times into the cornea in a circular pattern, which results in an increased curvature of the cornea to correct your vision. The correction you achieve from CK may be temporary.

CK is an elective procedure: There is no emergency condition or other reason that requires or demands that you have it performed. You could continue wearing contact lenses or glasses and have adequate visual acuity. This procedure, like all surgery, presents some risks, many of which are listed below. You should also understand that there may be other risks not known to your doctor, which may become known later. Despite the best of care, complications and side effects may occur; should this happen in your case, the result might be affected even to the extent of making your vision worse.

ALTERNATIVES TO CK

If you decide not to have CK, there are other methods of correcting your farsightedness. These alternatives include, among others, eyeglasses, contact lenses, and other refractive surgical procedures.

PATIENT CONSENT

In giving my permission for CK, I understand the following: The long-term risks and effects of CK are unknown. I have received no guarantee as to the success of my particular case. I understand that the following risks are associated with the procedure:

VISION THREATENING COMPLICATIONS

I understand that it is possible that damage to my cornea could also be caused by scarring, ulceration, or an eye infection that could not be controlled with antibiotics or other means.

NON-VISION THREATENING SIDE EFFECTS

I understand that visual acuity I initially gain from CK could regress, and that my vision may go partially or completely back to the level it was immediately prior to having the procedure.
I understand that I may not get a full correction from my CK procedure and this may require future enhancement procedures or the use of glasses or contact lenses. This procedure may also cause an increase in my astigmatism, which may cause blurred vision.
I understand that an over-correction could occur, causing me to become nearsighted, and that this nearsightedness could be either permanent or treatable.
I understand that the correction that I can expect to gain from CK may not be perfect and it is not realistic to expect that this procedure will result in perfect vision, at all times, under all circumstances, for the rest of my life. I understand I may need glasses to refine my vision for some purposes requiring fine detailed vision after some point in my life, and that this might occur soon after surgery or years later.
Patient Initials

I understand that there may be pain, scratchiness, a foreign body sensation, or slight dryness in my eye, particularly during the first 48 hours after surgery.
I understand that there may be increased sensitivity to light. I understand this condition usually resolves within the first few weeks following treatment, but it may also be permanent.
I understand that there may be a “balance” problem between my two eyes after CK has been performed on one eye, but not the other. This phenomenon is called anisometropia. I understand this would cause eyestrain and make judging distance or depth perception more difficult. I understand that my first eye may take longer to heal than is usual, prolonging the time I could experience anisometropia.
I understand I may temporarily experience corneal haze, small round hazy areas where the cornea was heated during the CK treatment. This haze will usually fade over time and may only be visible with a microscope within 3 months following surgery.
I understand that if I currently need reading glasses, I will still likely need reading glasses after this treatment.
Even 90% clarity of vision is still slightly blurry. Enhancement surgeries can be performed when vision is stable UNLESS it is unwise or unsafe. An assessment and consultation will be held with the surgeon at which time the benefits and risks of an enhancement surgery will be discussed.
I understand that there is a natural tendency of the eyelids to droop with age and that eye surgery may hasten this process.
I understand that the follow-up effects of CK are unknown and that CK has not been in use long enough to measure long-term effects (those occurring after 10 years or more) following the procedures, and that unforeseen complications or side effects could occur.
I understand that I may be given medication in conjunction with the procedure. I understand that I must not drive for at least one day following the procedure and not until I am certain that my vision is adequate for driving.
I understand that, as with all types of surgery, there is a possibility of complications due to anesthesia, drug reactions, or other factors that may involve other parts of my body. I understand that, since it is impossible to state every complication that may occur as a result of any surgery, the list of complications in this form may not be complete.

PATIENT’S STATEMENT OF ACCEPTANCE AND UNDERSTANDING

I have read and understand the information in the Patient Information booklet that has been provided to me. The details of the procedure known as CK have been presented to me in detail in this document and explained to me by my ophthalmologist. My ophthalmologist has answered all my questions to my satisfaction. I therefore consent to CK surgery.

I give permission for my ophthalmologist to record on video or photographic equipment my procedure, for purposes of education, research, or training of other health care professionals. I also give my permission for my ophthalmologist to use data about my procedure and subsequent treatment to further understand CK. 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 CK procedure will be performed.

Patient Signature Date

Witness Signature Date

I have been offered a copy of this consent form (please initial)

Wavefront Addendum

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(Courtesy of David A. Wallace, MD, a practicing ophthalmologist in Santa Monica, CA.)

Addendum or Insertion:
“Wavefront”-Guided Laser Vision Correction Surgery

Indications and Alternatives
“Standard” or “conventional” laser vision correction surgery refers to correction of spherical (near- or farsightedness) and cylindrical (astigmatic) refractive errors of the eye. Such treatment is rendered based upon measurements of the refraction, using lenses combined within an instrument called a phoropter.

“Wavefront”-guided treatment is based upon an imaging system called wavefront (aberrometer) measurement of the whole eye. In August of 2002, Alcon/Autonomous received FDA approval for use of its laser system (the LADARVision laser) in performing “Custom Cornea” treatments, guided by aberrometer (LADARWave) measurements; in June, 2004, the approval criteria were expanded. In May of 2003, Visx received similar approval for its “CustomVue” treatments using their WaveScan aberrometer and S4 laser, with approval for hyperopia with astigmatism in December, 2004.

Wavefront measurement is relatively new to the eye care profession, having evolved around imaging and manufacturing applications in the fields of astronomy, aerospace engineering, and photography. Wavefront measurement is able to detect subtle imperfections in an optical system that contribute to imperfect focus of an image. “Sphere” and “cylinder” are referred to as “low-order aberrations,” while other optical factors comprise the “higher-order aberrations.” Higher-order aberrations include spherical aberration, coma, trefoil, and others. Most people are not at all familiar with these terms. Unfortunately, it is not easy to graphically or pictorially represent the influence that higher-order aberrations have on human vision.

It is recognized that a minority of patients treated with conventional laser treatment describe some visual difficulties after their treatment, including glare, haloes around lights, diminished comfort at night, and ghosting of images (among other things). Data presented to the FDA suggests that a significant amount of these adverse visual consequences may be reduced by wavefront-guided treatment. The data also suggest that with wavefront-guided treatment a higher percentage of patients achieve better visual acuity, and a lower percentage have complaints, even in reduced illumination. The research was performed in very tightly-controlled circumstances on a relatively small number of patients (several hundred) by a small group of surgeons (less than 10). These results have not yet been reproduced or confirmed in large-scale studies on thousands of patients treated by larger numbers of surgeons in diverse settings more typical of the public domain.

Candidates for Wavefront-Guided Vision Correction
At present, the range of prescriptions treatable by wavefront-guided systems is narrower than the range of treatments approved for conventional treatment. Alcon’s LADARVision system is approved only for nearsightedness up to -8.00 diopters sphere, with -0.50D to -4.00D of astigmatism. The Visx Star S4 & WaveScan WaveFront System is approved for up to -6.00 D of myopia, with or without astigmatism up to -3.0 diopters, and for hyperopia with or without astigmatism up to +3.00D MRSE, with cylinder up to +2.00D.

Possible Advantages and Benefits of Wavefront-Guided Vision Correction
The advantages of wavefront-guided treatment may include:
•   A higher percentage of patients are reported to achieve better visual acuity (“20/20” and “20/15”) after wavefront ablation treatment than with conventional therapy. There is no guarantee that you will achieve these results.
•   A lower percentage of patients report glare, halo, or discomfort with night vision after treatment.
•   The process eliminates some of the subjective component of the refraction measurement process (the “Which is better, one or two?” part).

Possible Disadvantages and Risks of Wavefront-Guided Laser Vision Correction
There are some potential disadvantages to wavefront-guided treatment. These include (but are not limited to):
•   Wavefront-guided treatment removes more tissue (typically 18 – 30% more) than conventional treatment.
•   Currently, it is only possible to treat for “full distance correction” as a target, so it is not appropriate for those desiring monovision.
•   Wavefront treatment is currently more expensive than conventional treatment, and the supposed benefit is intangible, as it cannot always be measured.
•   Wavefront measurements of the eye, like refraction measurements, can fluctuate somewhat from hour to hour, day to day, or week to week.

Wavefront or Conventional Treatment?
As with any elective surgery decision, you are well-advised to make your decision based upon multiple factors. Speak to your surgeon; do your research; consult the websites of the laser manufacturers and the FDA; and satisfy your own curiosity before making a determination.

Patient’s Statement of Acceptance and Understanding
I have read and understand the above information about wavefront-guided vision correction surgery and wish to have this type of vision correction surgery on my _____ (indicate right or left) eye.

____________________________ __________________
Patient signature Date

____________________________ __________________
Witness signature Date

Revised 2/2005