Note: This form is intended as a sample form of the information that you as the surgeon should personally discuss with the patient. Please review 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.
Your ophthalmologist has diagnosed you with a condition that might benefit from Ozurdex™ (dexamethasone). This drug is indicated to treat a blockage in one of the blood vessels of your eye: a branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). The blockage causes swelling in the eye, loss of vision, and blurry vision. Ozurdex™ (dexamethasone) is also approved by the Food and Drug Administration to treat non-infectious uveitis affecting the posterior or back of your eye. Ozurdex™ (dexamethasone) is a biodegradable steroid implant used to reduce the swelling that occurs with blockages in the eye vessels and uveitis. It may improve how well you see. It may be used to treat other causes of swelling in the eye.
POSSIBLE LIMITATION 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 your disease. After the eye is numbed with anesthesia, the implant is injected into the vitreous, the jelly-like substance in the back part of your eye. Ozurdex™ (dexamethasone) is administered by an injection into your eye as needed; your ophthalmologist will tell you how often you will receive the injections.
You do not have to receive Ozurdex™ (dexamethasone) for your condition, although without any treatment, diseases like yours can lead to further vision loss and blindness, sometimes very quickly. Two other medications are approved by the Food and Drug Administration (FDA) to treat RVO: Lucentis™ (ranibizumab) and Eylea™ (aflibercept). Some eye surgeons use an anti-VEGF drug called Avastin™(bevacizumab) to treat AMD and refractory macular edema; this use of Avastin™ is off-label. Eye surgeons also use triamcinolone acetonide, a long-acting cortisone-like drug (Kenalog™, Triesence™, or Trivaris™) to treat eye conditions like yours. Your doctor will discuss with you the benefits and risks associated with these other choices of treatment.
COMPLICATIONS FROM THE MEDICATION AND INJECTION
Your condition may not get any better or may become worse. Any or all of the following complications may cause decreased vision or have the possibility of causing blindness. Additional medications or procedures, including surgery, may be needed to treat these complications. During the follow up visits, you will be checked for possible side effects and the results will be discussed with you.
COMPLICATIONS OF OZURDEX ™ (DEXAMETHASONE)
Possible complications and side effects of the procedure and administration of Ozurdex™ (dexamethasone) include but are not limited to infection in and around the eye (endophthalmitis), retinal detachment, cataract, glaucoma, intraocular hemorrhage, inflammation, damage to the retina or cornea, eye discharge, vitreous floaters, alterations in vision, elevated or decreased intraocular pressure, loss of vision, and/or loss of eye. You may receive eye drops with instructions on when to use them to reduce the possibility of complications. This drug may make it easier for secondary infections caused by bacteria, fungi, or viruses to occur. The implant might migrate to the front of the eye if the capsule in the back is not intact. Any of these rare complications may lead to severe, permanent loss of vision. The most common reactions to this drug are increased intraocular pressure and conjunctival bleeding (the mucous membrane covering the outer surface of the eye).
KNOWN RISKS OF INTRAVITREAL EYE INEJCTIONS
Patients receiving Ozurdex™ (dexamethasone) 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.
The above explanation has been read by/to me and I have been offered a copy of it to take home. The nature of my eye condition has been explained to me and the proposed treatment has been described. The risks, benefits, alternatives, and limitations have been discussed with me and all of my questions have been answered.
- I am not pregnant or nursing. ________ (patient intials)
- I may experience temporary visual blurring after receiving the injection and should not drive or operate heavy machinery until this clears up.
- 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 (other than the post injection redness from immediately after the procedure), 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 so my doctor can check for complications. ________ (patient intials)
I hereby authorize Dr. ___________ to administer the Ozurdex™(dexamethasone) implant in my
_____ Right eye _____ Left eye