Informed consent for cataract surgery

• What is a cataract and how is it treated?
  The lens in the eye can become cloudy and hard, a condition known as a cataract. Cataracts can develop from normal aging, from an eye injury, or if you have taken medications known as steroids. Cataracts may cause blurred vision, dulled vision, sensitivity to light and glare, and/or ghost images. If the cataract changes vision so much that it interferes with your daily life, the cataract may need to be removed. Surgery is the only way to remove a cataract. You can decide not to have the cataract removed. If you don’t have the surgery, your vision loss from the cataract will continue to get worse.
• How will removing the cataract affect my vision?
  The goal of cataract surgery is to correct the decreased vision that was caused by the cataract. During the surgery, the Dr.Rakesh shah removes the cataract and puts in a new artificial lens called an intraocular lens or IOL. Cataract surgery will not correct other causes of decreased vision, such as glaucoma, diabetes, or age-related macular degeneration. Most people still need to wear glasses or contact lens after cataract surgery for either near and/or distance vision and astigmatism.
• What Types of iols are availale?
  Dr.Rakesh shah will help you decide on the type of IOL that will replace your cloudy lens. There are IOLs available to treat nearsightedness (myopia), farsightedness (hyperopia), and astigmatism. IOLs usually provide either near or distance vision: these single focus lenses are called monofocal IOLs. Some newer IOLs can provide for near, intermediate, and distance vision: these multiple focus lenses are called multifocal IOLs. IOLs that treat astigmatism are called toric IOLs. You can also have one eye corrected for near vision, and the other for distance vision, a choice called monovision.
• What is astigmatism? Are there other treatments for it?
  Patients with nearsightedness and farsightedness often also have astigmatism. An astigmatism is caused by an irregularly shaped cornea; instead of being round like a basketball, the cornea is shaped like a football. This can make your vision blurry. In addition to toric IOLs, astigmatism can be reduced by glasses, contact lenses, and refractive surgery (LASIK or PRK). There is also a procedure called a limbal relaxing incision (LRI), which can be done at the same time as the cataract operation, or as a separate procedure. A limbal relaxing incision (LRI) is a small cut or incision Dr.Rakesh shah makes into your cornea to make its shape rounder. Any attempt at astigmatism reduction could result in over- or under-correction, in which case glasses, contact lenses, or another procedure may be needed.
• What are the major risks of cataract surgery?
  All operations and procedures are risky and can result in unsuccessful results, complications, injury, or even death, from both known and unknown causes. The major risks of cataract surgery include, but are not limited to bleeding; infection; injury to parts of the eye and nearby structures from the anesthesia, the operation itself, or pieces of the lens that cannot be removed; high eye pressure; a detached retina, and a droopy eyelid. The major risks of a limbal relaxing incision are similar to those for cataract surgery, but also include loss of vision, damage to the cornea, and scarring; under- or over-correction could occur.
  Depending upon your eye and the type of IOL, you may have increased night glare or halos, double vision, ghost images, impaired depth perception, blurry vision, and trouble driving at night. The ophthalmologist might not be able to put in the IOL you choose. In addition, the IOL may later need to be repositioned or replaced.
  Depending upon the type of anesthesia, other risks are possible, including cardiac and respiratory problems, and, in rare cases, death. There is no guarantee that cataract surgery or astigmatism reduction will improve your vision. As a result of the surgery and/or 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. You may need additional treatment or surgery to treat these complications. This additional treatment is not included in the fee for this procedure.
• Patient’s acceptance of risks
  I understand that it is impossible for the doctor to inform me of every possible complication that may occur. By signing below, I agree that my doctor has answered all of my questions, that I have been offered a copy of this consent form, and that I understand and accept the risks, benefits, and alternatives of cataract surgery. I have checked my choice for astigmatism correction and type of IOL.
  ________Monofocal IOL/Glasses Option I wish to have a cataract operation with a monofocal IOL on my ____(state “right” or “left” eye) and wear glasses for ________ (state “near” or “distance”) vision.
  __________Monovision with 2 IOLs Option (may still need glasses) I wish to have a cataract operation with two different-powered IOLs implanted to achieve monovision. I wish to have my ______________ (state “right” or “left”) eye corrected for distance vision. I wish to have my ___________ (state “right” or “left”) eye corrected for near vision.
  __________Multifocal IOL Option (may still need glasses) I wish to have a cataract operation with a _____________________ multifocal IOL implant (state name of implant) on my _______________ (state “right” or “left”) eye.
  __________Toric monofocal IOL/Glasses Option for Astigmatism Reduction I wish to have a cataract operation with a toric monofocal IOL on my _______________ (state “right” or “left” eye) and wear glasses for _____________________ (state “near” or “distance”) vision.
  __________Limbal Relaxing Incision for Astigmatism Reduction (may still need glasses) I wish to have a this procedure done in addition to the cataract operation.
  ______________________
  Patient (or person authorized to sign for patient) Date
  Patient’s relative sign_____________
  Counsellor’s sign___________________
  Doctor’s sign ___________________
  Place___________________

Informed Consent For Intravitreal Injection

• Indications
  Age-related macular degeneration (AMD) is the leading cause of blindness in people over 50 years of age. There are two types of macular degeneration: dry and wet. In the “wet” form of AMD, abnormal blood vessels grow in the back of the eye. Sometimes these vessels leak blood or fluid that causes blurred or distorted vision. Without treatment, vision loss may be quick and severe.
  There are other eye conditions that cause loss of vision due to abnormal growth of blood vessels in the back of the eye. These can occur even in young patients, and include, but are not limited to, conditions such as high myopia (nearsightedness), histoplasmosis, angioid streaks, and eye injury. Sometimes there is no known reason for the abnormal blood vessels. Without treatment, vision loss may be quick and severe.
  Refractory macular edema, or swelling around the macula, is edema that affects vision but does not respond adequately to the usual treatment methods. It can occur with conditions such as central retinal vein occlusion and diabetic retinopathy. Without effective treatment, vision loss could progress and become permanent.
• Possible benefits and “off-label” status
  Avastin™ was not initially developed to treat your eye condition. Based upon the results of clinical trials that demonstrated its safety and effectiveness, Avastin™ was approved by the Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer. As a condition of approval, the manufacturer produced a “label” explaining the indications, risks, and benefits. The label explains that Avastin™ works by blocking a substance known as vascular endothelial growth factor or VEGF. Blocking or inhibiting VEGF helps prevent further growth of the blood vessels that the cancer needs to continue growing.
  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. Ophthalmologists are using Avastin™ “off-label” to treat AMD and similar conditions since research indicates that VEGF is one of the causes for the growth of the abnormal vessels that cause these conditions. Some patients treated with Avastin™ had less fluid and more normal-appearing maculas, and their vision improved. Avastin™ is also X used, therefore, to treat macular edema, or swelling of the macula. Recently, a medication similar in function and designed for intravitreal administration was approved by the FDA for the treatment of AMD.
• Possible limitations and administration
  The goal of treatment is to prevent further loss of vision. Although some patients have regained vision, the medication may not restore vision that has already been lost, and may not ultimately prevent further loss of vision caused by the disease. After the pupil is dilated and the eye is numbed with anesthesia, the medication is injected into the vitreous or jelly-like substance in the back chamber of the eye. Avastin™ is administered by an injection into your eye as needed at regular intervals (about every four to six weeks); your ophthalmologist will tell you how often you will receive the injection, and for how long.
• Alternatives
  You do not have to receive treatment for your condition, although without treatment, these diseases can lead to further vision loss and blindness, sometimes very quickly. Other forms of treatment are available. At present, there are three FDA-approved treatments for Neovascular Age-Related Macular Degeneration. The first two are photodynamic therapy with a drug called Visudyne™ and injection into the eye of a drug called Macugen™. Although both of these treatments have been proven to slow down the rate of visual loss, most people do not get back better vision. The third medication, Lucentis™ is similar to Avastin™. Your doctor will discuss with you the benefits and risks associated with these other choices of treatment. In addition to the FDA-approved medications, some ophthalmologists use intravitreal Kenalog™-a long-acting cortisone-like drug-“off-label” to treat eye conditions like yours.
• Complications from the medication and injection
  • Complications when Avastin™ is given to patients with cancer
    When Avastin™ is given to patients with metastatic colorectal cancer, some patients experienced serious and sometimes life-threatening complications, such as gastrointestinal perforations or wound healing complications, hemorrhage, arterial thromboembolic events (such as stroke or heart attack), hypertension, proteinuria, and congestive heart failure. Patients who experienced these complications not only had metastatic colon cancer, but were also given 400 times the dose you will be given, at more frequent intervals, and in a way (through an intravenous infusion) that spread the drug throughout their bodies.
  • Risk when Avastin™ is given to treat patients with eye conditions
    Ophthalmologists believe that the risk of these complications for patients with eye conditions is low. Patients receiving Avastin™ for eye conditions are healthier than the cancer patients, and receive a significantly small dose, delivered only to the cavity of their eye. While there are no FDA-approved studies about the use of Avastin™ in the eye that prove it is safe and effective, Lucentis™, a similar drug, was recently approved for AMD. One study of patients who received Avastin™ through an intravenous infusion reported only a mild elevation in blood pressure. Another study of patients treated like you will be with intravitreal Avastin™ (that is, Avastin™ injected into the eye) did not have these elevations or the other serious problems seen in the patients with cancer.
    However, the benefits and risks of intravitreal Avastin™ for eye conditions are not yet fully known. In addition, whenever a medication is used in a large number of patients, a small number of coincidental life-threatening problems may occur that have no relationship to the treatment. For example, patients with diabetes are already at increased risk for heart attacks and strokes. If one of these patients being treated with Avastin™ suffers a heart attack or stroke, it may be caused by the diabetes and not the Avastin™ treatment.
• Known risks of intravitreal eye injections
  Your condition may not get better or may become worse. Any or all of these complications may cause decreased vision and/or have a possibility of causing blindness. Additional procedures may be needed to treat these complications. During the follow up visits or phone calls, you will be checked for possible side effects and the results will be discussed with you.
  Possible complications and side effects of the procedure and administration of AvastinTM include but are not limited to retinal detachment, cataract formation (clouding of the lens of the eye), glaucoma (increased pressure in the eye), hypotony (reduced pressure in the eye), damage to the retina or cornea (structures of the eye), and bleeding. There is also the possibility of an eye infection (Endophthalmitis). You may receive eye drops with instructions on when to use them to reduce the possibility of this occurring. Any of these rare complications may lead to severe, permanent loss of vision.
  Patients receiving an injection of AvastinTM may experience less severe side effects related to the pre-injection preparation procedure (eyelid speculum, anesthetic drops, dilating drops, antibiotic drops, povidone-iodine drops and the injection of the anesthetic). These side effects may include eye pain, subconjunctival hemorrhage (bloodshot eye), vitreous floaters, irregularity or swelling of the cornea, inflammation of the eye, and visual disturbances.
• Patient responsibilities
  I will immediately contact my ophthalmologist if any of the following signs of infection or other complications develop: pain, blurry or decreased vision, sensitivity to light, redness of the eye (compared to immediately after the injection), or discharge from the eye. I have been instructed NOT to rub my eyes or swim for three days after each injection. I will keep all post-injection appointments or scheduled telephone calls so my doctor can check for complications.
  Patient initials
  Although the likelihood of serious complications affecting other organs of my body is low, I will immediately contact my primary care physician or go to the Emergency Room if I experience abdominal pain associated with constipation and vomiting, abnormal bleeding, chest pain, severe headache, slurred speech, or weakness on one side of the body. As soon as possible, I will also notify my ophthalmologist of these problems. Patient initials
  I will inform my ophthalmologist if I need to have any surgery, and I will inform any other surgeon, including dentists, that I am on a medication that needs to be stopped before I can have surgery. Patient initials
  
  
• Patient Consent
  The above explanation has been read by/to me. The nature of my eye condition has been explained to me and the proposed treatment has been described. The risks, benefits, alternatives, and limitations of the treatment have been discussed with me. All my questions have been answered.
  I understand that AvastinTM was approved by the FDA for the treatment of metastatic colorectal cancer, and has not been approved for the treatment of eye conditions. Nevertheless, I wish to be treated with AvastinTM, and I am willing to accept the potential risks that my physician has discussed with me.
  Patient initials
  I hereby authorize Dr. __________________ to administer the intra-vitreal injection of AvastinTM in my _______ (state “right” or “left”) eye at regular intervals as needed. This consent will be valid until I revoke it or my condition changes to the point that the risks and benefits of this medication for me are significantly different.
  Patient’s Name ___________________
  Date ______________
  (Signature) Patient’s relative sign_______________
  Relation__________________
  Counsellor’s sign___________________________
  Doctor’s sign _______________
  Place _______________
  Date______________

Informed consent for laser in-situ keratomileusis (lasik)

• Introduction
  This information is being provided to you so that you can make an informed decision about the use of a device known as a microkeratome, combined with the use of a device known as an excimer laser, to perform LASIK. LASIK is one of a number of alternatives for correcting nearsightedness, farsightedness and astigmatism. In LASIK, the microkeratome is used to shave the cornea to create a flap. The flap then is opened like the page of a book to expose tissue just below the cornea’s surface. Next, the excimer laser is used to remove ultra-thin layers from the cornea to reshape it to reduce nearsightedness. Finally, the flap is returned to its original position, without sutures.
  LASIK 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 lasik If you decide not to have LASIK, there are other methods of correcting your nearsightedness, farsightedness or astigmatism. These alternatives include, among others, eyeglasses, contact lenses and other refractive surgical procedures.
• Patient consent
  In giving my permission for LASIK, I understand the following: The long-term risks and effects of LASIK 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 the microkeratome or the excimer laser could malfunction, requiring the procedure to be stopped before completion. Depending on the type of malfunction, this may or may not be accompanied by visual loss.
  • I understand that, in using the microkeratome, instead of making a flap, an entire portion of the central cornea could be cut off, and very rarely could be lost. If preserved, I understand that my doctor would put this tissue back on the eye after the laser treatment, using sutures, according to the ALK procedure method. It is also possible that the flap incision could result in an incomplete flap, or a flap that is too thin. If this happens, it is likely that the laser part of the procedure will have to be postponed until the cornea has a chance to heal sufficiently to try to create the flap again.
  • I understand that irregular healing of the flap could result in a distorted cornea. This would mean that glasses or contact lenses may not correct my vision to the level possible before undergoing LASIK. If this distortion in vision is severe, a partial or complete corneal transplant might be necessary to repair the cornea.
  • I understand that it is possible a perforation of the cornea could occur, causing devastating complications, including loss of some or all of my vision. This could also be caused by an internal or external eye infection that could not be controlled with antibiotics or other means.
  • I understand that mild or severe infection is possible. Mild infection can usually be treated with antibiotics and usually does not lead to permanent visual loss. Severe infection, even if successfully treated with antibiotics, could lead to permanent scarring and loss of vision that may require corrective laser surgery or, if very severe, corneal transplantation or even loss of the eye.
  • I understand that I could develop keratoconus. Keratoconus is 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.
  • I understand that other very rare complications threatening vision include, but are not limited to, corneal swelling, corneal thinning (ectasia), appearance of “floaters” and retinal detachment, hemorrhage, venous and arterial blockage, cataract formation, total blindness, and even loss of my eye.
• Non-vision threatening side effects
  
  • I understand that there may be increased sensitivity to light, glare, and fluctuations in the sharpness of vision. I understand these conditions usually occur during the normal stabilization period of from one to three months, but they may also be permanent.
  • 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.
  • I understand that an overcorrection or undercorrection could occur, causing me to become farsighted or nearsighted or increase my astigmatism and that this could be either permanent or treatable. I understand an overcorrection or undercorrection is more likely in people over the age of 40 years and may require the use of glasses for reading or for distance vision some or all of the time.
  • 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. 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.
  • I understand that I may not get a full correction from my LASIK procedure and this may require future enhancement procedures, such as more laser treatment or the use of glasses or contact lenses.
  • I understand that there may be a “balance” problem between my two eyes after LASIK 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 that, after LASIK, the eye may be more fragile to trauma from impact. Evidence has shown that, as with any scar, the corneal incision will not be as strong as the cornea originally was at that site. I understand that the treated eye, therefore, is somewhat more vulnerable to all varieties of injuries, at least for the first year following LASIK. I understand it would be advisable for me to wear protective eyewear when engaging in sports or other activities in which the possibility of a ball, projectile, elbow, fist, or other traumatizing object contacting the eye may be high.
  • 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 there may be pain or a foreign body sensation, particularly during the first 48 hours after surgery.
  • I understand that temporary glasses either for distance or reading may be necessary while healing occurs and that more than one pair of glasses may be needed.
  • I understand that the long-term effects of LASIK are unknown and that unforeseen complications or side effects could possibly occur.
  • I understand that visual acuity I initially gain from LASIK could regress, and that my vision may go partially back to a level that may require glasses or contact lens use to see clearly.
  • I understand that the correction that I can expect to gain from LASIK may not be perfect. I understand that 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.
  • I understand that I may be given medication in conjunction with the procedure and that my eye may be patched afterward. I therefore, understand that I must not drive the day of surgery and not until I am certain that my vision is adequate for driving.
  • I understand that if I currently need reading glasses, I will still likely need reading glasses after this treatment. It is possible that dependence on reading glasses may increase or that reading glasses may be required at an earlier age if I have this surgery.
  • Even 90% clarity of vision is still slightly blurry. Enhancement surgeries can be performed when vision is stable UNLESS it is unwise or unsafe. If the enhancement is performed within the first six months following surgery, there generally is no need to make another cut with the microkeratome. The original flap can usually be lifted with specialized techniques. After 6 months of healing, a new LASIK incision may be required, incurring greater risk. In order to perform an enhancement surgery, there must be adequate tissue remaining. If there is inadequate tissue, it may not be possible to perform an enhancement. 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, 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.

For presbyopic patients (those requiring a separate prescription for reading): The option of monovision has been discussed with my ophthalmologist.

Informed consent for corneal transplant surgery

• What is corneal transplant surgery? Why do i need it?
  The cornea is the clear, dome-shaped tissue that covers the front surface of your eye. Light rays enter your eye through the cornea, which is the main focusing element of your eye. Because of damage to the tissues of your cornea, light does not pass normally through your cornea, and may result in significant vision loss. Corneal transplantation, also known as corneal grafting or penetrating or lamellar keratoplasty, is a surgical procedure to replace the damaged or diseased portion of your cornea with healthy corneal tissue from a deceased donor. Although the outcome of your surgery cannot be guaranteed, the potential benefit that may result from this surgery is improvement in your vision, reduced pain, preservation of the anatomy and integrity of the eye, and improved appearance of a damaged or diseased cornea. Corneal transplantation may also be performed to remove inflamed or infected corneal tissue when other treatments have not worked.
• What are the alternatives to corneal transplant surgery?
  You can choose not to have this surgery. If you do not have surgery, your corneal condition will stay the same or worsen over time. Patients with certain corneal conditions and disorders may be treated with non-surgical methods such as eyeglasses, rigid gas permeable corneal lenses (RGP), Intacs® (intrastromal corneal ring segments), or the Boston scleral lens prosthetic device (BSCPD). The choice of treatment depends upon the type and severity of the corneal condition or disorder. Patients with corneal conditions that involve only certain layers of the cornea may be candidates for corneal surgery to treat those specific layers.
• What is corneal transplant surgery like?
  The surgical procedure is performed by an ophthalmologist, a medical doctor and surgeon who specializes in the diagnosis and treatment of eye conditions and diseases. The procedure is often done on an outpatient basis. With the eye under local or general anesthesia, your ophthalmic surgeon will create an incision to remove a portion of your cornea. Your surgeon will then replace the abnormal cornea with a donor cornea and secure it in place. Depending on your needs, a full thickness or partial thickness donor transplant may be used. Your surgery will take approximately one to two hours, and you should be able to go home the same day. You may be given drops to take after the surgery to reduce the risk of infection and swelling (inflammation) and will be instructed on their use. You may need to lie flat on your back for a while after the surgery, and lifting may also be restricted.
• What are the some of the potential complications of surgery?
  Any surgical procedure carries potential risks, and it is possible this surgery may make your vision worse. Complications associated with corneal transplant surgery may include:
  • Rejection of the cornea and possible need for another transplant (5-30% depending on the condition of your eye before surgery). A repeat transplant can be performed in most conditions
  • Elevated pressure in the eye (glaucoma) that may require medication or surgery to correct
  • Infection which may result in reduced vision even when treated with antibiotics
  • Increased risk of clouding of the eye’s lens (cataract)
  • Problems with the stitches used to hold the transplant in place which may require a second surgical procedure to replace the stitches
  • Swelling of the cornea resulting in reduced vision
  • Imbalance in vision between the two eyes
  • Need for glasses or contact lenses to correct vision, and changing glasses/contact lens prescription as healing progresses.
  • Swelling in the retina located in the back of your eye (cystoid macular edema)
  • Retinal detachment
  • Partial or total loss of your vision, or loss of your eye
  • Drooping of your eyelid
  • Bleeding inside and around your eye
  • Discomfort or possible pain
  • Rarely, the transmission of infectious diseases can occur such as Hepatitis, AIDS, and syphilis, although the corneal donor is routinely tested for these diseases before the tissue is approved and released for transplantation.
  • Additional surgery to treat complications
• What type of anethesia is used? What are its major risks?
  There are some risks associated with anesthesia, whether general or local. Complications of anesthesia injections around the eye may include: perforation of the eyeball, injury to the optic nerve resulting in loss of vision, hemorrhage, retinal detachment, interference with retinal circulation resulting in possible vision loss, drooping of the upper eyelid, hypotension or lowering of the blood pressure, and respiratory depression. General anesthesia can result in heart and breathing problems, and in very unusual and rare instances, death or diminished brain function can occur.
• Patient’s acceptance of risks
  I have read the above information and have discussed it with my physician. I understand that it is impossible for the physician to inform me of every possible complication that may occur. My physician has told me that results cannot be guaranteed. By signing below, I agree that my physician has answered all of my questions to my satisfaction and I give informed consent to proceed with corneal transplant surgery on my __________ (state “right” or “left” eye.
  Patient Signature________________
  Date_________________________
  Patient’s relative sign____________
  Counsellor’s sign___________________
  Doctor’s sign ___________________
  Date___________________
  Place___________________
  

Informed consent for corneal transplant surgery

• What is retina detachment and how is a scleral buckle used to treat this condition?
  Scleral buckling surgery is a way to treat retinal detachment. Retinal detachment occurs when the two layers of the retina, the sensory retina and the retinal pigment epithelium (RPE), become separated from each other and from the wall of the eye. Retinal detachment can lead to severe vision loss or blindness.
  A scleral buckle is a piece of silicone sponge, rubber, or semi-hard plastic that your eye surgeon places on the outside of the eye (the sclera, or the white of the eye). The material is stitched down to the eye to keep it in place. The buckling element is usually left in place permanently. The element pushes in, or “buckles,” the sclera toward the middle of the eye. This buckling effect on the sclera relieves the pull (traction) on the retina, allowing the retinal tear to settle against the wall of the eye. The buckle effect may cover only the area behind the detachment, or it may encircle the eyeball like a ring
  Usually extreme cold (cryopexy) or heat (diathermy) or light (laser photocoagulation) is used to treat the retina and hold it in place until a seal forms between the retina and the layer beneath it. The seal holds the layers of the eye together and keeps fluid from getting between them.
  Dr.Rakesh shah may inject a gas bubble into your eye to flatten the retina. He may also drain the fluid under the detached retina through a tiny hole in the sclera. If there is only a small amount of fluid, draining it may not be needed. The retina can remove small amounts of fluid by itself.

Benefits

• Risks associated with this procedure.
  Scleral buckling poses some short-term and long-term risks. The most common cause of failure in surgery for retinal detachment is a type of abnormal scarring on the retina, called proliferative vitreoretinopathy (PVR) that can cause the retina to detach again. PVR usually requires additional treatment, including vitrectomy surgery. Other possible risks are:
  • Detachment of the choroid, the middle layer of tissue that forms the eyeball, is a common complication of scleral buckling surgery. Choroidal detachments usually heal on their own within about 2 weeks without further treatment. The pressure of the scleral buckle can raise the fluid pressure inside the eyeball. People with glaucoma may have a higher risk of this complication.
  • Bleeding in the eye can impair vision.
  • The eye may become infected. You may need antibiotics and corticosteroids to reduce redness or discharge from the eye and treat the infection.
  • Sometimes it is necessary to remove the buckling implant to treat the infection.
  • You may have swelling or inflammation of the macula (the central portion of the retina), other parts of the retina, or the membranes surrounding the retina.
  • The silicone plastic or rubber of the buckling device may rub on other parts of the eye, move out of place, or become a site of infection. In some cases, the buckling device may need to be removed.
  • Many people need more than one operation. Surgery always poses some risks.
  • A scleral buckle can change the shape of the eye, changing your refraction (power of your glasses). You may need glasses or contact lenses (or a new prescription) to correct the changes.
  • The scleral buckle can affect the eye muscles and how well they control the movement of the eyes. This can lead to misaligned eyes (strabismus) and double vision (diplopia).
  • Cataracts may form after surgery, although they are less common with scleral buckling than with pneumatic retinopexy or vitrectomy, the other types of surgery used to treat retinal detachments.
  • Ptosis or droopy eyelid.
• Alternative treatments
  Alternative treatments to a scleral buckle procedure are available. For example pneumatic retinopexy may be recommended by your surgeon. This procedure involves the use of a bubble of gas to push the retina against the wall of the eye, allowing fluid to be pumped out from beneath the retina. Or a vitrectomy may be recommended to remove clear gel-like vitreous which is tugging the retina from its normal position. Dr.Rakkesh shah will discuss these alternatives but feels that a scleral buckle is the best choice in your situation.
• How will this procedure affect my vision and/or condition?
  Placing a scleral buckle reattaches the retina in most cases. Chances for good vision after surgery are higher if the macula was still attached before surgery. If the detachment affected the macula, good vision after surgery is still possible but less likely.
• What type of anethesia is used? What are its major risks?
  
  • Scleral buckle surgery is performed under local (injection) or anesthesia, with sedation. General anesthesia may be used instead in some cases. Retinal detachment surgery is usually performed as an outpatient (day surgery) procedure. In some cases a hospital stay overnight may be required.
  • There are some risks associated with anesthesia, whether general or local. Complications of anesthesia injections around the eye may include: perforation of the eyeball, injury to the optic nerve resulting in loss of vision, hemorrhage, retinal detachment, interference with retinal circulation resulting in possible vision loss, drooping of the upper eyelid, hypotension or lowering of the blood pressure, and respiratory depression. General anesthesia can result in heart and breathing problems, and in a very unusual and rare instances, death or diminished brain function can occur.
• Patient’s acceptance of risks
  I understand that it is impossible for the doctor to inform me of every possible complication that may occur. By signing below, I agree that my doctor has answered all of my questions, that I have been offered a copy of this consent form, and that I understand and accept the risks, benefits, and alternatives of scleral buckle surgery.
  I wish to have a ____________________ operation on my ____________________ (state “right” or “left” eye).
  Patient (or person authorized to sign for patient)____________________
  Date_____________
  Patient’’s relative sign___________________
  Counsellor’’s sign___________________
  Doctor’s sign___________________
  Date___________________
  Place___________________
• Alternatives to the surgery
  
  • The available alternatives, some of which include pneumatic retinopexy or a scleral buckling procedure for those patients who have a retinal detachment. The potential benefits and risks of the proposed procedure, and the likely result without such treatment have been explained to me.
  • Additional Comments: _____________________
• How will the vitrectomy procedure affect my vision and/or condition?
  Vitrectomy has been shown to improve visual acuity in many people who have severe vitreous hemorrhage that has not cleared on its own. A vitrectomy can decrease the risk of severe bleeding complications in people who have begun to have bleeding into the vitreous gel. It can also reduce the risk of severe bleeding into the eye in people with growth of abnormal blood vessels in the iris. If the surgery is being done for a retinal detachment the visual result will depend on the extent of the detachment and absence of a secondary detachment later.
• What type of anethesia is used? What are its major risks?
  
  • A Vitrectomy is performed under local (injection) or anesthesia, with sedation. General anesthesia may be used instead in some cases. It is typically performed as an outpatient procedure. In some cases a hospital stay overnight may be required.
  • There are some risks associated with anesthesia, whether general or local. Complications of anesthesia injections around the eye may include: perforation of the eyeball, injury to the optic nerve resulting in loss of vision, hemorrhage, retinal detachment, interference with retinal circulation resulting in possible vision loss, drooping of the upper eyelid, hypotension or lowering of the blood pressure, and respiratory depression. General anesthesia can result in heart and breathing problems, and in a very unusual and rare instances, death or diminished brain function can occur.
• What are the major risks of vitrectomy surgery?
  There is no guarantee that the surgery will improve your condition. Sometimes it doesn’t work. In addition, surgery is risky. Sometimes it can make the problem worse, cause an injury, or create a new problem; if it does, this is called a complication. Complications can happen right away or not until days, months, or years later. You may need more treatment or surgery to treat the complications. This document lists the major risks of vitrectomy surgery to help you decide whether you are ready to accept the risks. After vitrectomy surgery, you may have vision loss, blindness, loss of the eye, as well as bleeding, infection, and injury to the eye or nearby body parts. Other major risks can include:
  • Retinal detachments that may require additional surgery or may be inoperable
  • Elevated eye pressure (glaucoma)
  • Poorly healing or non healing corneal defects
  • Corneal clouding and scarring
  • Cataract, which might require eventual or immediate removal of the lens
  • Double Vision
  • Eye lid droop
  • Loss of circulation to vital tissues in the eye, resulting in decrease or loss of vision
  • Phthisis (disfigurement and shrinkage of eyeball)
• Additional comments:
  __________________________ __________________________ __________________________
• Patient's Acceptance of Risks
  I have read the above information (or it was read to me) and have discussed it with my physician. I understand that it is impossible for the physician to inform me of every possible complication that may occur. My physician has told me that results cannot be guaranteed and that more treatment or surgery may be necessary. By signing below, I agree that my physician has answered all of my questions and that I understand and accept the risks, benefits, and alternatives of vitrectomy surgery. I have been offered a copy of this document. I wish to have a _____________________ operation on my ____________________ (state “right” or “left” eye).
  Patient (or person authorized to sign for patient)
  Patient’s relative sign____________________
  Counsellor’s sign___________________
  Doctor’s sign ___________________..
  Date___________________..
  Place___________________..