白内障手术知情同意书(英文模板)

INFORMED CONSENT FOR CATARACT EXTRACTION WITH IMPLANT



AMBULATORY EYE SURGERY CENTER OF LOUISIANA

INTRODUCTION


The following 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 consent. You have the right to ask questions about any procedure before agreeing to have the operation.


Except for unusual problems, cataract surgery is indicated only when you cannot function adequately due to poor sight produced by a cataract. You must remember that if the natural lens within your own eye has a slight cataract, although vision may not be perfect, it still has some distinct advantages over any man-made lens.



State and federal laws require us to obtain your consent for your contemplated surgical procedure. You are signing a consent for surgery. The consent states that we have discussed with you the risks, benefits, and alternatives to the proposed procedure. We have already discussed with you the common problems or undesired results that sometimes occur. WE WISH TO INFORM YOU, NOT TO ALARM YOU. Please read the form carefully. Ask about anything that you do not understand. We will be pleased to explain.



DESCRIPTION OF PROPOSED PROCEDURE



In general terms, the nature and purpose of this operation is to cut and remove the cataract (cloudy lens) from your RIGHT/LEFT eye and to replace it with an intraocular lens implant, if possible, in order to try to improve your sight.



ALTERNATIVE TREATMENT OF CATARACT REMOVAL

AND LENS IMPLANTATION



Cataract surgery, by itself, means the removal of the natural, but cloudy lens of the eye by a surgical technique. There is no known alternative treatment other than no surgery at all. External lasers do not remove cataracts. In order for an intraocular lens to be implanted in your eye, you must have cataract surgery performed either at the time of the lens implantation or before the lens implantation.



Before you decide to have a cataract operation, you should understand completely the three methods of restoring useful vision after the operation. One of the three methods listed below is required to correct your vision after surgery:



1. Spectacles (glasses) – Cataract spectacles are usually thicker and heavier than regular eyeglasses. Cataract spectacles increase the size of objects by about 25%. Clear vision is obtained only through the center part of cataract spectacles. This means you must learn to turn your head to see clearly on either side. Cataract spectacles usually cannot be used if a cataract is only in one eye (and the other is normal), because they may cause double vision.
2. Contact Lens – A hard or soft contact lens increases the size of objects only about 8%. Handling of a contact lens can be difficult for some individuals. Most lenses must be inserted and removed daily and not everyone can tolerate them. For near tasks, eyeglasses (not thick cataract spectacles) may be required in addition to contact lenses.

3. Intraocular Lens – This is a small plastic, silicone, hydrogel, or acrylate artificial lens with supports, which is surgically and permanently placed inside your eye. The intraocular lens (IOL) appears to show no change in the size of objects you see. Conventional eyeglasses (not thick cataract spectacles) are usually needed in addition to an intraocular lens to give you the best vision possible. Greater than 99% of all cataract patients choose this method of visual rehabilitation following cataract extraction.


TWO TYPES OF INTRAOCULAR LENS IMPLANTS MAY BE USED



A. “Hard” Intraocular Lens – This is a small artificial lens, usually made from a plastic material called polymenthimethacrylate (PMMA) with an ultraviolet (UV) light absorbing additive. It is believed that the addition of the UV absorbing material to the intraocular lens may aid in protecting the retina from potentially damaging effects of the ultraviolet light rays present in the normal environment. The long-term damaging effects of the ultraviolet light or the ultraviolet absorbing additives have not yet been documented. Most PMMA lenses have blue polypropylene or other clear plastic supports. These lenses are surgically and permanently placed inside the eye. With the intraocular lens there is no apparent change in the size of objects seen. Conventional eyeglasses (not thick cataract spectacles) will most likely be required in addition to the soft lens implant.

B. Foldable Intraocular Lens – “Soft” or foldable intraocular lenses are usually made of silicone, hydrogel, or acrylate material. They are foldable and can be inserted through smaller incisions than those needed to implant hard intraocular lenses. After implantation, no apparent change in the size of objects should be seen. Conventional eyeglasses (not thick cataract spectacles) will most likely be required in addition to the soft lens implant.

C. Investigational Intraocular Lens – Some intraocular lenses are investigational (non-FDA-approved) devices. If such a lens is used and could subject you to additional risks, a separate addendum will be attached to this consent form explaining such risks.


If you have a preference of an intraocular lens type (hard vs foldable), please notify your surgeon. Otherwise, your doctor will choose the type believed best for you. If an intraocular lens is implanted, it is done by surgical method. It is intended that the implant remains in your eye permanently. The result of the surgery cannot be guaranteed in your or anyone’s case. At the time of surgery, your doctor may decide not to implant an intraocular lens in your eye even though you may have given prior permission to do so. Your doctor may also decide to change the type of implant used during the surgery if he feels it necessary.

BENEFITS

The primary benefit that may be derived from intraocular lens implantation is the restoration of useful vision following removal of a cataract. An intraocular lens does not require removal, cleaning, and/or disinfecting (as with contact lenses) and does not appreciably magnify objects. Since an intraocular lens is implanted inside the eye permanently, useful vision is available at all times of the day.


Additional benefits that may be derived from the implantation of a soft intraocular lens include reduced trauma to the eye and rapid rehabilitation due to the use of a smaller incision.


RISKS


Complications of surgery to eye: Cataract extraction with lens implantation is a highly successful procedure. However, as with any surgery there exist some risks. In some cases, complications may occur during the surgery, or days, weeks, months or even years later. Some complications may include problems that are currently unforeseeable. Known complications may include: glaucoma (elevated pressure in the eye), vitreous loss (displacement of vitreal jelly), loss of corneal clarity, infection, inflammation in the eye, bleeding in the eye, distorted pupil, inability to dilate the pupil, unpredicted postoperative prescription, intraocular surgical contaminants, ptosis (droopy eyelid), dislocation of the cataract during surgery, dislocation of the implant, retinal detachment, total loss of vision, and/or loss of the eye.



All postoperative cataract patients run the risk of developing a “secondary cataract,” or scar tissue behind the implant after the cataract surgery, causing blurry vision that may require laser surgery to that eye to regain useful vision.



Complications of local anesthesia of the eye: In most cases, cataract surgery is performed under “local” or “topical” anesthesia. This means that you are awake for the surgery, but that anesthesia is given on, around, and/or behind the operated eye. If injections are used, they usually do not hurt since a short acting medication is given to put you to sleep only for the duration of the anesthetic injections. Although small, there is the potential for complications if injections are used, which include: retrobulbar hemorrhage (bleeding behind the eye), infections, subconjunctival hemorrhage (bruising of the eye), eyelid ecchymosis (bruising of the eyelid), diplopia (double vision), ocular muscle palsy (paralysis of eye movement), global penetration (needle entering the eyeball), or blindness.


PATIENT STATEMENT


I hereby authorize and direct the authorized surgeon named below, together with any associates and assistants of his choice, to perform the surgical procedure(s) described in this consent, including any additional medical or surgical procedures or services as they deem necessary or reasonable, including, but not limited to, the administration of drugs; topical, regional, or general anesthesia; removal and/or disposal of any tissue; and use of photography or videotaping for documentation or teaching purposes; and I hereby consent thereto.



The basic procedure of cataract extraction with intraocular lens surgery and the advantages and disadvantages, risks and possible complications of the surgery and its alternative treatment have been explained to me by my doctor. Although it is impossible for my doctor to inform me of every possible complication that may occur, the doctor has answered all my questions to my satisfaction. I understand that the implanting of this intraocular lens in my eye will require periodic visits to an eye doctor by me for at least one month postoperatively to evaluate the results of my operation. In signing this Informed Consent, I am stating that I have read this Consent Form, that I understand the surgery’s risks, benefits, and alternatives, as explained by my physician, and that I consent to having CATARACT REMOVAL WITH INTRAOCULAR LENS IMPLANTATION RIGHT/LEFT EYE performed. I acknowledge that I may receive a copy of this consent for my use if I so desire.



DO NOT SIGN THIS FORM UNTIL YOU HAVE READ AND UNDERSTOOD IT.



____________________________ ___________________

SIGNATURE DATE





____________________________ ___________________

WITNESS DATE



I am unable to read, but this consent form has been read and explained to me by _______________________ (name of reader). I understand the information stated above. I am willingly signing this Consent Form



____________________________ ___________________

SIGNATURE DATE





____________________________ ___________________

2nd WITNESS (required) DATE



I certify that all blanks in this form were filled in prior to signature and I explained them to the patient or his representative before requesting the patient or his representative to sign it.



_____________________________ _____________________________

NAME OF AUTHORIZED SURGEON SURGEON’S SIGNATURE

(Please print)




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