Informed Consent For Cataract Surgery and/or Implantation of an Intraocular Lens
This information is given to you so that you can make an informed decision about having eye surgery. Take as much time as you wish to make your decision about signing this informed consent document. You have the right to ask any questions you might have about the operation before agreeing to have it. Please read this form in its entirety. Fill out as much of the information as you are comfortable with and bring it with you to your biometry appointment.
With aging, or due to trauma, disease or medications, the lens inside the eye becomes cloudy. This condition is called a cataract. There is no medical treatment for a cataract. Surgery can be performed to replace the cloudy lens with an intraocular lens implant (IOL). This is an artificial lens, usually made of silicone or acrylic plastic material, surgically and permanently placed inside the eye. Eyeglasses may be required after surgery to obtain the best vision.
Except for unusual situations, a cataract operation is indicated only when you cannot function satisfactorily due to decreased vision caused by the cataract. After your doctor has told you that you have a cataract, you and your doctor are the only ones who can determine if or when you should have a cataract operation, based upon your own visual needs and medical considerations. You may decide not to have a cataract operation at this time. Non-surgical alternatives are continued wear of glasses or contact lenses to maximize your vision despite the presence of the cataract.
EXAMINATIONS PRIOR TO SURGERY
To determine that you are a candidate to have cataract surgery, you have already undergone a complete eye examination by your surgeon. This included an examination to determine your glasses prescription (refraction), measurement of your vision (visual acuity), measurement of the pressures inside your eye (tonometry), microscopic examination of the front part of your eye (slit-lamp examination), and examination of the retina of your eye with your pupils dilated.
A biometry appointment has been scheduled to perform additional measurements of the curvature of your cornea (keratometry) and the length of your eye (axial length). An intraocular lens calculation (biometry) to determine the best estimate of the proper power of the implanted IOL will be performed at this appointment. You will have the opportunity to ask any questions you may have and a date for your surgery will be scheduled.
If you wear contact lenses, you will be required to leave them out of the eyes for a period of time prior to your biometry appointment. This is necessary because the contact lens rests on the cornea, distorting its shape, and decreasing the accuracy of the measurements. Incorrect measurements will result in vision being much poorer than was planned. Discontinuing contact lens use allows the corneas to return to their natural shape. Soft contact lens wearers must leave lenses out of both eyes for at least one week before their scheduled biometry appointment. Rigid (including gas permeable and standard hard lenses) contact lens wearers should leave lenses out of both eyes for at least three weeks before the biometry appointment. Rigid contact lens wearers frequently experience fluctuating vision once their lenses have been discontinued due to changes in the shape of the cornea. Although the cornea usually returns to its natural state within three weeks, this process may take longer, and you will need to remain contact lens free until stabilization is complete.
Please bring a list of all your medications, including over the counter supplements and vitamins with you to your appointment. Furthermore, please inform the surgical coordinator if you are now or have in the past taken any of the following medications: Flomax (tamsulosin), Hytrin (terazosin), Cardura (doxazosin), Uroxatral (alfuzosin) or Rapaflo (silodosin). These medications are usually used in men to treat urinary retention due to an enlarged prostate, but are sometimes also taken by women for urinary problems. Any of these medications can increase the risk of complications from cataract surgery. The risk of problems from these medications can be greatly reduced if your surgeon is forewarned that you have been exposed to any of these medications.
MORE INFORMATION ABOUT INTRAOCULAR LENS BIOMETRY
While biometry, the method used to calculate the power of the IOL, is very accurate in the majority of patients, the final result may be different from what was planned. As the eye heals, the IOL can shift very slightly toward the front or the back of the eye. The amount of this shift is not the same in everyone, and it may cause different vision than predicted. Patients who are highly nearsighted or farsighted have the greatest risk of differences between planned and actual outcomes. Patients who have had LASIK or other refractive surgeries are especially difficult to measure precisely. If the eye’s visual power after surgery is considerably different than what was planned, surgical replacement of the IOL may be considered. It is usually possible to replace the IOL and improve the situation through a second surgical procedure or glasses or contact lenses can be used.
PRESBYOPIA AND ALTERNATIVES FOR NEAR VISION AFTER SURGERY
Presbyopia is a natural loss of the elasticity of the natural lens over time. It is the reason that reading glasses become necessary, typically after age 40, even for people who have excellent distance vision without glasses. Presbyopic individuals require bifocals or separate (different prescription) reading glasses in order to see clearly at close range. Conventional cataract surgery places a monofocal (single focus) IOL in the eye. There are several options available to you to achieve acceptable distance and near vision after cataract surgery.
- GLASSES: You can choose to have a monofocal (single focus) IOL implanted for distance vision and wear separate reading glasses, or have the IOL implanted for near vision and wear separate glasses for distance. This is the option that most patients choose.
- MONOVISION: Your surgeon can implant IOLs with two different powers, one for near vision in one eye, and one for distance vision in the other eye. This combination of a distance eye and a reading eye is called monovision, and would allow you to read without glasses. It has been employed quite successfully in many contact lens and refractive surgery patients.
For most people, depth perception is best when viewing with both eyes optimally corrected and “balanced” for 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 typically recommended that this option be tried with contact lenses (which are removable) prior to contemplating monovision correction involving two IOLs.
Ocular dominance, and choosing the ‘distance’ eye correctly: Ocular dominance is analogous to right- or left-handedness. Typically, eye care professionals believe that for most individuals, one eye is the dominant or preferred eye for viewing. Several tests can be performed to determine which eye, right or left, is dominant in a particular person. Conventional wisdom holds that if contemplating monovision, the dominant eye should be corrected for distance, and the non-dominant eye corrected for near. While this is a good guideline, it should not be construed as an absolute rule. A very small percentage of persons may be co-dominant (rather analogous 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 the use of contact lenses which combination is best for each person (right eye for distance, left for near, or vice versa) prior to undertaking surgical implantation of two different-powered IOLs during cataract surgery. You can imagine how uncomfortable it might be if monovision were to be rendered “the wrong way around.” It might be compared to a right-handed person suddenly having to write, shave, apply make-up, etc., with the left hand. Be sure you understand this and have discussed with your surgeon which eye should be corrected for distance, and which for near. If you have any doubts or uncertainty whatsoever, surgery should be delayed until a very solid comfort level is attained through the use of monovision contact lenses. Under no circumstances should you consider undertaking cataract surgery with monovision 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 distance and near eye without some loss of visual quality.
- MULTIFOCAL IOL: Your surgeon can implant a multifocal IOL. These IOLs, more recently approved by the Food and Drug Administration (FDA), provide distance vision and near vision in the same eye. These lenses can be placed in both eyes to achieve the highest chance of being spectacle-free. Several types of lenses are available. Depending upon the technological features of the IOLs, they may be described as “accommodating,” “apodized diffractive,” or “presbyopia-correcting.” All of these lenses are “multifocal,” meaning they correct for both distance vision and other ranges, such as near or intermediate. After implantation in both eyes, about 80% of patients never wear glasses. An additional 15% use glasses for some activities. It is important to realize that it spectacle independence cannot be guaranteed.
While a multifocal IOL can reduce dependency on glasses, it might result in less sharp vision, which may become worse in dim light or fog. It may also cause some visual side effects such as rings or circles around lights at night. It may be difficult to distinguish an object from a dark background, which will be more noticeable in areas with less light. Driving at night may be affected. A small percentage of people have severe night vision problems. The lens is not recommended for individuals who drive a considerable amount at night or for pilots. If complications occur at the time of surgery, a monofocal IOL may need to be implanted instead of a multifocal IOL.
At the time of the biometry appointment, some testing in addition to that performed for conventional monofocal surgery are performed. Additional keratometry readings, corneal topography, ultrasound measurements of the retina (OCT) and ocular dominance testing are performed. An additional visit with your surgeon will also be arranged before the surgery to review the results of these studies and the survey form that you completed. You and your surgeon will finalize which multifocal lens would work the best for you.
Medicare has determined that multifocal IOLs and the additional associated services for determining the appropriate IOL in conjunction with cataract surgery are only partially covered. Expenses in excess of those incurred for conventional cataract surgery are the responsibility of the patient electing this type of surgery. In the event of complications from the surgery, it may be possible that additional procedures, eye drops or even hospitalization may be required. Some or all of these costs may be covered by health insurance. If they are not, the patient is responsible for these costs.
In some people, the cornea is not perfectly round. Astigmatism is the result when the cornea has two distinct curvatures. The result of astigmatism is blurry vision because objects are focused into two separate images. Astigmatism can be corrected by glasses or contact lenses. None of the IOLs discussed previously correct astigmatism. Surgical correction of astigmatism is possible at the time of cataract surgery by implanting a toric IOL. This IOL is a monofocal IOL that has an additional component to correct astigmatism. Patients who chose this lens can have distance or near correction or can have monovision. Multifocal toric IOLs are not available at this time. Patients with astigmatism who are interested in a multifocal IOL must have their astigmatism corrected by another surgical procedure in addition to cataract surgery. Other surgical options for astigmatism correction include refractive surgery (LASIK or PRK) or limbal relaxing incisions (LRI). These astigmatism correcting surgeries are typically performed after the eye has healed from the cataract surgery and incur additional expense that is generally not covered by insurance companies.
While the majority of patients with toric IOL implants are very pleased with their results, in the US FDA clinical trials a higher incidence in visual disturbances were reported with these lenses when compared with conventional monofocal lenses. Events during surgery may make it impossible to implant a toric IOL and a monofocal lens will be implanted instead.
If you decide to have surgery using a toric IOL, additional measurements beyond those performed for monofocal IOL implantation are necessary. At the time of your biometry appointment, additional keratometry readings and corneal topography will be performed. An additional visit with your surgeon will be scheduled to review the results of this testing and your surgeon will choose the lens strength that is most appropriate for you.
Medicare has determined that toric IOLs and the additional associated services for fitting them in conjunction with cataract surgery are only partially covered. Expenses in excess of those incurred for conventional cataract surgery are the responsibility of the patient electing this type of surgery. In the event of complications from the surgery, it may be possible that additional procedures, eye drops or even hospitalization may be required. Some or all of these costs may be covered by health insurance. If they are not, the patient is responsible for these costs.
ANESTHESIA, PROCEDURE, AND POSTOPERATIVE CARE
A nurse will make your eye numb with drops and an anesthetic gel placed on the eye. You may also undergo light sedation administered by a nurse anesthetist, or elect to have the surgery done under general anesthesia.
An incision, or opening, is then made in the eye. This is usually self-sealing but it may require closure with very fine stitches (sutures) which will gradually dissolve over time. The natural lens in your eye will then be removed by a type of surgery called phacoemulsification, which uses a vibrating probe and sound waves (ultrasound) to break the lens up into small pieces. These pieces are gently suctioned out of your eye through a small, hollow tube inserted through the small incision in your eye. After your natural lens is removed, the IOL is placed inside your eye. In rare cases, it may not be possible or safe to implant the IOL you have chosen, or any IOL at all.
After the surgery, your eye will be examined the next day, and then at intervals determined by your surgeon. During the immediate recovery period, you will place drops in your eyes for about 4 weeks, depending on your individual rate of healing. You should be able to resume your normal activities within a week, and your eye will usually be stable within 4 to 6 weeks, at which time glasses or contact lenses could be prescribed.
RISKS OF CATARACT SURGERY
The goal of cataract surgery is to correct the decreased vision that was caused by the cataract. Cataract surgery will not correct other causes of decreased vision, such as glaucoma, diabetes, age-related macular degeneration or macular pucker. Cataract surgery is usually quite comfortable. Mild discomfort for the first 24 hours is typical, but severe pain would be extremely unusual and should be reported immediately to the surgeon.
Cataract surgery is generally a very safe procedure with a very low complication rate. However, all surgeries carry some risks and can result in unsuccessful outcomes, complications, or injury. 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. Depending upon the type of anesthesia, other risks are possible, including cardiac and respiratory problems, and, in rare cases, death.
Risks of cataract surgery include, but are not limited to:
- Complications of removing the natural lens may include bleeding; rupture of the capsule that supports the IOL; swelling and clouding of the cornea, which can require a corneal transplant; swelling in the central retina (called cystoid macular edema), which can lead to a permanent reduction in vision; retained pieces of lens in the eye, which may need to be removed in a second surgery; infection; detachment of the retina (particularly in highly nearsighted patients), but which can usually be repaired; eye pain; a droopy eyelid; increased astigmatism; glaucoma; or double vision. These and other complications may occur whether or not an IOL is implanted and may result in poor vision, total loss of vision, or even loss of the eye in rare situations. Additional surgery may be required to treat these complications.
- Complications associated with the IOL may include increased night glare and/or halo, double or ghost images, and dislocation of the IOL. Multifocal IOLs have an increased likelihood of glare and halos. In some instances, corrective lenses or surgical replacement of the IOL may be necessary for adequate visual function following cataract surgery.
- Complications associated with local anesthesia injections around the eye include injury to the optic nerve, interference with the circulation of the retina, a droopy eyelid, and double vision.
- If complications occur at the time of surgery, it may not be safe to implant an IOL in your eye even though you may have given prior permission to do so.
- The selection of the proper IOL, while based upon sophisticated equipment and computer formulas, is not an exact science. After your eye heals, its visual power may be different from what was predicted by preoperative testing. You may need to wear glasses or contact lenses after surgery to obtain the best vision. Additional surgeries such as IOL exchange, placement of an additional IOL, limbal relaxing incisions, or refractive laser surgery may be needed if you are not satisfied with your vision after cataract surgery.
- The results of surgery cannot be guaranteed. If you chose a multifocal IOL, it is possible that not all of the near (and intermediate) focusing ability of your eye will be restored. Additional surgery, glasses or contact lenses may be necessary.
- Regardless of the IOL chosen, you may develop an after-cataract, or clouding of the capsule behind the IOL. This may happen years after the surgery and is treated with an in-office laser procedure to restore vision.
- At some future time, the IOL implanted in your eye may dislocate and have to be repositioned, removed surgically, or exchanged for another IOL.
- If your ophthalmologist has informed you that you have a high degree of hyperopia (farsightedness) and/or that the axial length of your eye is short, your risk for a complication known as a choroidal effusion is increased. This complication could result in difficulties completing the surgery and implanting a lens, or even loss of the eye.
- If your ophthalmologist has informed you that you have a high degree of myopia (nearsightedness) and/or that the axial length of your eye is long, your risk for a complication called a retinal detachment is increased. Retinal detachments can usually be repaired but may lead to vision loss or blindness.
- Since only one eye will undergo surgery at a time, you may experience a period of imbalance between the two eyes, particularly if the eye that did not have surgery is either very farsighted or very nearsighted. Glasses may not be able to correct this problem because of the marked difference in the prescriptions, so you will either temporarily have to wear a contact lens in the non-operated eye or will function with only one clear eye. In the absence of complications, surgery in the second eye can usually be accomplished within 3 to 4 weeks, once the first eye has stabilized.
Cataract surgery, by itself, means the removal of the natural lens of the eye by a surgical technique. In order for an IOL to be implanted in my eye, I understand I must have cataract surgery performed either at the time of the IOL implantation or before IOL implantation. If my cataract was previously removed, I have been informed that my eye is medically acceptable for IOL implantation.
The basic procedures of cataract surgery, the reasons for the type of IOL chosen for me, and the advantages and disadvantages, risks, and possible complications of alternative treatments have been explained to me by my ophthalmologist. 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.
In signing this informed consent for cataract operation and/or implantation of an IOL, I am stating that I have been offered a copy, I fully understand the possible risks, benefits, and complications of cataract surgery and I have read this informed consent or had it read to me by _______________________________ (name).
CHOOSE ONE OF THESE FOUR OPTIONS (check only one):
◊ Monofocal IOL/Glasses Option: I wish to have a cataract operation with a monofocal IOL on my RIGHT/LEFT eye and wear glasses for NEAR/DISTANCE vision.
◊ Monovision Option: I wish to have a cataract operation with an IOL implanted to achieve monovision. I wish to have my RIGHT/LEFT eye corrected for DISTANCE/NEAR vision.
The items or services below are not fully covered by insurance companies. Medicare and most other insurers will pay for removal of the cataract, a monofocal IOL and the pre-operative testing to determine the correct power of the monofocal implant. Extra expenses for toric and mutifocal IOLs including the implants themselves, additional office visits and pre-operative testing are not covered benefits and are directly billable to the patient. Choosing one of these options will result in “out-of-pocket” expenses.
◊ Multifocal IOL Option: I wish to have a cataract operation with a multifocal IOL implant on my RIGHT/LEFT eye.
◊ Toric monofocal IOL Option: I wish to have a cataract operation with an IOL that corrects astigmatism on my RIGHT/LEFT eye and wear glasses for NEAR/DISTANCE vision.
Patient (or person authorized to sign for patient) Date
Witness Signature Date