Risk Management



Photodynamic Therapy with Visudyne® Consent Form

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

Version 7/13/05

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                                                   

 

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