Retisert™ Consent form

INFORMED CONSENT FOR Retisert^TM

(fluocinolone acetonide intravitreal implant)

WHAT WILL RETISERT^TM DO?

Your eye surgeon (ophthalmologist) has told you that you have posterior uveitis, one of the leading causes of blindness for middle-aged people in the Western world. Posterior uveitis is a long-term condition that causes inflammation or swelling in the back of the eye that leads to vision loss.  Retisert^TM has been approved by the Food and Drug Administration (FDA) to decrease the inflammation. Your eye surgeon will need to perform surgery to place the Retisert^TM implant into the back of your eye. The Retisert^TM implant will deliver the medication for about 30 months. Once it runs out of medication, it can be replaced if you still need it.

ALTERNATIVES

You do not have to receive this treatment for your eye condition. Without treatment, posterior uveitis can lead to further vision loss and blindness. However, other treatments for posterior uveitis are available. Such alternative treatments include other drugs to decrease inflammation which can be taken as pills, shots or drops. These treatments are not approved by the FDA for the treatment of posterior uveitis.

COMPLICATIONS FROM THE MEDICATION AND SURGERY

• Almost all patients temporarily lose vision right away after surgery. This will last from one to four weeks. 
• After about 8 months, most patients develop high eye pressure (glaucoma) that can cause vision loss and hurt the nerve in the eye. High eye pressure needs to be treated with eye drops. After about two years, many patients need surgery to control the pressure in their eye.
• After about two years, almost all patients develop a cloudy lens or cataract and need to have it removed. An artificial lens is inserted, but most patients also need glasses to see well.
• Other complications include but are not limited to infection, low eye pressure, and having parts of the eye detach. 
• Your eye condition may not get better and may even get worse or lead to blindness even with the surgery. 
• If you have the complications, you may need more surgery to treat them. Any of these complications, or the additional surgery, can lead to permanent vision loss or even blindness.

PATIENT RESPONSIBILITIES

I will immediately contact my ophthalmologist (eye surgeon) if I experience any signs of complications including, but not limited to, pain, blurry or decreased vision, sensitivity to light, redness of the eye, or discharge from the eye.  I will keep all post-operative appointments or scheduled telephone calls so my doctor can check for complications.            ________        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 hereby authorize Dr. __________________ to implant Retisert^TM (fluocinolone acetonide intravitreal implant) in my _______ (state “right” or “left”) eye. 

____________________________    ___________________

Patient’s Signature                                          Date

Periocular Repository Corticosteriod Injections

POTENTIAL COMPLICATIONS ASSOCIATED WITH PERIOCULAR REPOSITORY CORTICOSTEROID INJECTION(S)

1. Inadvertent injection into the choroidal or retinal circulation, emboli.
2. Perforation of the globe with permanent loss of vision/loss of eye.
3. Cataract.
4. Glaucoma (increased eye pressure) in injected/other eye that may be transient or permanent and could lead to medical or surgical treatment (i.e., excision of depot or glaucoma filtering operation).
5. Blepharoptosis.
6. Proptosis.
7. Orbital fat atrophy, fibrosis.
8. Delayed hypersensitivity reactions.
9. Strabismus.
10. Conjunctival hemorrhage.
11. Chemosis.
12. Infection.
13. Pain from injection, syncope, adhesions, worsening of condition, Cushing’s Syndrome, pupillary dilatation.

Patient Signature                                                                                Date

Photodynamic Therapy with Visudyne® Consent Form

Photodynamic Therapy with Visudyne (Verteporfin) Consent

This information is given to you so that you may make an informed decision.  Take as much time as you wish to review this informed consent, and make sure all of your questions have been  answered to your satisfaction before signing this consent.

INDICATIONS AND BENEFITS

Your ophthalmologist has determined that you have a sight-threatening eye condition caused

by new growth of abnormal blood vessels called choroidal neovascularization. These blood vessels leak fluid under the macula, then form scar tissue leading to vision loss. If left untreated, the abnormal blood vessel lesion may become larger, causing scarring and permanent loss of central vision.

Photodynamic Therapy is a newer treatment option.  This type of cold laser allows the abnormal blood vessels to close without causing heat damage to the overlying healthy retina.  Benefits included potential improvement or stabilization of the retinal lesion, therefore decreasing the rate of visual loss.  Photodynamic Therapy requires the injection of the drug Visudyne. 

You will receive a 10-minute intravenous (IV) infusion of Visudyne. The dosage of medication is determined by each individual patient’s height and weight.  Infusion-related problems include leaking of fluid at the infusion site that can lead to skin injury, back pain, and allergic sensitivity to the infused medication.  An activating light (laser) will be shone in your eye 5 minutes after the infusion ends. This laser is a much lower energy than is used in conventional laser surgery and has no effect without the Visudyne drug in the circulation.   The liver rapidly eliminates Visudyne. Therefore, you may notice that your stools are dark in color for a few days after treatment.

Only 1-4% of patients have improved vision after Visudyne Photodynamic Therapy treatment.  The purpose of these treatments is to decrease the rate of visual loss and stabilize the retinal lesion.  In order to obtain stabilization of the retinal lesion, Visudyne Therapy is generally repeated multiple times on the same eye over the ensuing years.

ALTERNATIVE TREATMENTS

Older treatment options are Laser Photocoagulation; this treatment uses heat to burn the abnormal retinal lesion but also destroys the surrounding healthy retina, causing permanent scarring and central visual loss.  Laser Photocoagulation does not require drug injection.

PRECAUTIONS

It is very important that you give a complete medical and surgical history and that you tell us all medications you are taking, even medication you are currently taking without a prescription. These include vitamins, minerals, and over the counter medications.  If you have a history of any type of liver disease or disorder, you must let your doctor know prior to treatment with Visudyne.  

• To the best of my knowledge, I do not have any liver disease or disorder. _______ (Initial)

There are no adequate and well-controlled studies involving pregnant or nursing women.  Visudyne should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

• To the best of my knowledge, I am not currently pregnant.  _______ (Initial or N/A)                                                                                                                                               

NEED TO AVOID SUNLIGHT AND BRIGHT LIGHT AFTER INFUSION

Patients who receive Visudyne will become temporarily photosensitive after the infusion and are to avoid direct sunlight for 5 days.  During that period, you should avoid exposure of unprotected skin, eyes or other body organs to direct sunlight or bright indoor light.  This includes, but is not limited to, tanning salons, bright halogen lighting, and high power lighting used in surgical operating rooms or dental offices. If you must go outdoors in daylight during the first 5 days after treatment, you should protect all parts of your skin and eyes by wearing protective clothing

and dark sunglasses.  UV sun-screens are not effective in protecting against photosensitivity reactions. There is no need to stay in the “dark,” and it is encouraged that you expose your skin to ambient indoor light. This will help inactivate the drug in the skin through a process called photo bleaching. Failure to comply with the above recommendations can lead to serious injury including skin burns.

REASONS TO CONTACT US IMMEDIATELY

If you require emergency surgery within five (5) days after treatment, or if you go to the emergency room or another doctor/dentist within five (5) days, please inform the ophthalmologist or the doctor on call immediately.  It is very important that your eyes, skin and body organs are not exposed to bright indoor lights.

RISKS, COMPLICATIONS, AND SIDE EFFECTS

The most frequently reported problems noted in clinical studies were headaches, injection site reactions including extravasation and rashes, visual disturbances including blurred vision, decreased visual acuity, and visual field defects.  These events occurred in approximately 10-30% of patients.  Severe vision loss occurred in 1-5% of patients.  Partial recovery of vision was observed in some patients.

These events were reported more frequently by patients receiving Visudyne than those who got a placebo (1-10% of patient): back pain (primarily during infusion), photosensitivity reactions usually in the form of skin sunburn following exposure to sunlight; chest pain and other musculoskeletal pain during infusion; hypersensitivity reactions which can be severe; syncope (fainting); severe allergic reaction with dyspnea and flushing; fever; atrial fibrillation; hypertension; peripheral vascular disorder; gastrointestinal cancers, nausea, anemia, white blood cell count decreased or increased, elevated liver function tests, albuminuria, creatinine increased, vertigo, decreased hearing,  double vision, prostatic disorder.

Rare events (less than 1%) include retinal detachment, retinal or choroidal vessel non-perfusion.

Over dosage of Visudyne and/or light in the treated eye may result in non-perfusion of normal retinal vessels with the possibility of severe decrease in vision that could be permanent.

• WARNING:  Following injection with Visudyne, care should be taken to avoid exposure of skin or eyes to direct sunlight or bright indoor light for five (5) days. In the event of extravasation during infusion (leakage of drug at injection site) the skin area must remain thoroughly protected from direct light until swelling and discoloration have faded in order to prevent local skin burn which could be severe. If emergency surgery is necessary within five days after treatment, as much of the internal tissue as possible should be protected from intense light.

My doctor and/or his assistant have explained this procedure to me. I have had all

of my questions answered to my satisfaction and I fell confident that I am making an informed decision.

Patient’s printed name:___________________________________

Patient’s signature:__________________________________   Date:____________

Signature of Witness:________________________________   Date:_____________

_____Copy sent home with patient.              

Version 7/13/05                                                   

Macugen™ Consent Form

IF YOU ARE ASSESSING WITH A MOBILE DEVICE OR TABLET OR YOU WISH TO SAVE THIS FORM TO YOUR COMPUTER USE THE DOWNLOAD BUTTON. A PREVIEW OF THE FORM IS DISPLAYED BELOW.

PLACE LETTERHEAD HERE AND REMOVE NOTE.  

CHANGE FONT SIZE FOR LARGE PRINT

NOTE:  THIS FORM IS INTENDED AS A SAMPLE FORM.  IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT.  PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE.  GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.

NOTE TO PHYSICIANS: 

[REMOVE THIS SECTION FROM CONSENT FORM]

Patient selection:  to determine if patients are eligible for Macugen™, they should be evaluated for lesion type, location, and size, and have at least an initial fluorescein angiogram.  

To prevent complications associated with intravitreal injections such as endophthalmitis, retinal detachment, and increased intraocular pressure, review the latest guidelines on care before, during, and after injections.  One source is the article by Flynn, Harry W., Scott, Ingrid U., Evolving Guidelines for Intravitreous Injections.  Retina 24:S3-S19, 2004.

Macugen injections are given every six weeks for up to a year or longer.  In general, informed consent may be considered to have continuing force and effect until the patient revokes the consent or until circumstances (e.g., the patient’s medical or ocular condition) change so as to materially affect the nature of the procedure or the risk/benefit ratio.  Prior to subsequent injections, the continued need, effectiveness, and safety of the medication should be evaluated and documented.  If the patient’s medical or ocular condition changes to the point that the risk/benefit ratio is affected, it would be prudent to either discontinue treatment or obtain and document informed consent again.

The FDA approval states that only one eye at a time should be injected.  The FDA also notes that the safety and efficacy of Macugen after two years has not been demonstrated, and that Macugen was noted to be less effective the second year.  Further studies should provide guidance in the use of Macugen for greater than two years.

CONSENT FOR MACUGEN™ INTRAVITREAL INJECTION

Patient:_________________ Record #:_________________

INDICATIONS

You have an eye condition called age-related macular degeneration (AMD).  AMD is the leading cause of blindness in people over 50 years of age.  It is caused by the breakdown of the central portion of the retina (the nerve layer part of your eye that works like the film in a camera to pick up the picture) called the macula.  The macula is responsible for the fine central vision in the eye that is needed for driving a car, reading fine print, recognizing faces, etc. 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.  Vision loss may be quick and severe. 

ADMINISTRATION AND BENEFITS

Macugen™ works by stopping the growth of new blood vessels that damage the macula. The goal is to slow down the vision loss.  Although a number of patients have regained some vision, the medication may not restore vision that has already been lost.  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. Macugen^TM is administered by an injection into your eye every six weeks for up to one year or longer.

ALTERNATIVES

You do not have to receive treatment for your condition, although without treatment, the disease can lead to further vision loss and blindness. Other forms of treatment may be available, such as focal laser photocoagulation or photodynamic therapy.  Your doctor will discuss with you the benefits and risks associated with other choices of treatment.

COMPLICATIONS FROM THE MEDICATION AND INJECTION

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.

Macugen^TM may cause allergic reactions in a small number of people.  Symptoms of an allergic reaction can include a rash, hives, itching, shortness of breath, and rarely death.  In general, allergic reactions to medicines are more likely to occur in people who have allergies to other drugs, foods, or things in the environment, such as dust or grass.  If you have allergies to other medicines, foods, or other things in the environment, or if you have asthma, you should let your doctor know.

Possible complications and side effects of the procedure and administration of Macugen^TM 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.

Patients receiving an injection of Macugen™ may experience some 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, cataract, and visual disturbances.

The most frequently reported adverse events in patients treated with Macugen^TM are anterior chamber inflammation (inflammation inside the eye), blurred vision, cataract, conjunctival or subconjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, increased intraocular pressure (IOP), ocular discomfort, punctate keratitis (irritation of the cornea), reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities.

PATIENT RESPONSIBILITIES

I will contact my ophthalmologist immediately 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 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 hereby authorize Dr. __________________ to administer the intravitreal injection of Macugen^TM in my _______ (state “right” or “left”) eye every six weeks.  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 Signature                                               Date

____________________________ __________________

                   Witness’s Signature                                    Date

Version 04/7/05

DSEK Corneal Transplant Surgery Recommendations

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