Penetrating Keratoplasty (PK) Corneal Transplant Consent Form

The cornea is the clear, outermost layer of the eye. Vision is lost if the cornea becomes swollen, cloudy, or damaged from infection, disease, trauma, or aging. If the cornea does not heal, it needs to be removed surgically in order for vision to improve. You can decide not to have the corneal transplant.  If you don’t have the surgery, your vision loss from the damaged cornea will remain and may continue to get worse.

BESIDES PK CORNEAL TRANSPLANT SURGERY, HOW ELSE CAN MY DAMAGED CORNEA BE TREATED?

Patients with certain corneal conditions and disorders may be treated with eyeglasses, rigid gas permeable corneal lenses (RGP), Intacs® (intrastromal corneal ring segments), or theBostonscleral lens prosthetic device (BSCPD). The choice of treatment depends upon the type and severity of the corneal condition or disorder. In some patients, only the inner layer of the cornea, the endothelium, needs to be replaced. These patients can be treated with a different type of corneal transplant surgery known as Descemet’s stripping endothelial keratoplasty or DSEK.

HOW WILL HAVING A PK CORNEAL TRANSPLANT AFFECT MY VISION?

The goal of a PK corneal transplant is to improve the decreased vision that was caused by the diseased or damaged cornea; a PK corneal transplant will not correct decreased vision caused by other eye conditions such as a cataract or glaucoma. The eye surgeon or ophthalmologist removes the three layers of the damaged cornea by making a circle cut or incision, and replaces the damaged cornea with a donor cornea, which is kept in place with stitches (sutures). This type of surgery can be combined if needed with other eye surgeries, such as cataract removal or glaucoma surgery. The operation takes from 45 to 60 minutes.

WHAT ARE THE MAJOR RISKS OF A PK CORNEAL TRANSPLANT?

As with all eye surgery, you may experience an infection, bleeding, swelling of the retina causing temporary or permanent blurring of vision, a retinal detachment, glaucoma or high pressure in the eye, rejection of the transplanted tissue, chronic swelling or inflammation, double vision, a droopy eyelid, loss of corneal clarity, poor vision, total loss of vision, or even loss of the eye. 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.

There are also complications from the local anesthesia including perforation of the eyeball, damage to the optic nerve, a droopy eyelid, interference with the circulation of the blood vessels in the retina, respiratory depression, and hypotension. On rare occasions, useful vision can be permanently lost or you may die.

The donor cornea is kept in place with stitches or sutures. The sutures can come loose, cause infections, or change the shape of the cornea. This changed corneal shape is called astigmatism and can cause blurry vision. Astigmatism can be treated with glasses, but if it is severe, contact lenses or more surgery may be needed. Once the cornea is cut, it remains more delicate, and can break open from trauma or injury, even several years after the surgery.

It takes about 6 to 12 months for your vision to improve. Corneal transplants are successful in 90 out of 100 patients. The transplant is rejected by the body in 8 out of 100 patients. If the surgery is not successful, or the transplant is rejected, you will need another corneal transplant to see well.

There is no guarantee that PK corneal transplant 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 PK corneal transplant  surgery.

I wish to have a PK corneal transplant procedure on my _________ (state “right” or “left” eye).

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Patient’s signature (or person authorized to sign for patient)             Date

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Patient name

Retina Surgery Consent (Addendum to General Consent Form)

[ADDENDUM TO GENERAL CONSENT FORM]

RETINA SURGERY

Complications which could occur weeks, months, or even years later

1. Failure to accomplish intent of surgery
2. Retinal detachment that may require additional surgery or may be inoperable
3. Vitreous hemorrhage
4. Infection
5. Elevated eye pressure (glaucoma)
6. Poorly healing or non-healing corneal defects
7. Corneal clouding and scarring
8. Cataract, which might require eventual or immediate removal of lens
9. Double vision
10. Eyelid droop
11. Loss of circulation to vital tissues in the eye, resulting in decrease or loss of vision
12. Permanent blindness, or diminished visual acuity or field
13. Loss of eye

CRYOPEXY

In addition to the risks for retina surgery:

1. Retinal detachment or macular puckering that may require additional surgery
2. Inflammation
3. Pigmentary disturbances

Additional comments:

Patient (or person authorized to sign for patient)                                   Date

Witness                                                                                                          Date

Orbital and Plastic Surgery Consent (Addendum to General Consent)

Additional comments:

Patient (or person authorized to sign for patient)                                      Date

Witness                                                                                                          Date

Laser Surgery Consent (Addendum to General Consent)

Additional comments:

Patient (or person authorized to sign for patient)                                   Date

Witness                                                                                                          Date

Jetrea® (ocriplasmin) Consent

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INFORMED CONSENT FOR TREATMENT OF SYMPTOMATIC VITREOMACULAR ADHESION WITH INTRAVITREAL INJECTION OF JETREA® (OCRIPLASMIN)

WHAT IS SYMPTOMATIC VITREOMACULAR ADHESIONAND HOW IS IT TREATED?

The retina, a light-sensitive tissue that lines the back of the eye, absorbs light and sends visual signals to the brain, where they are processed into images. The macula is a small, specialized area of the retina responsible for clear, detailed vision.  The vitreous is a clear, jelly-like liquid that fills the inside of the eye between the lens in the front of the eye and the retina.

With age, the vitreous begins to liquefy and separate from the retina., For most people, this occurs without complication.

Sometimes, the vitreous does not fully separate from the back of the eye and remains attached to the macula.  This abnormal attachment is known as vitreomacular adhesion (VMA).  If the VMA persists, pulling on the macula can occur and cause symptoms with your vision, known as symptomatic VMA.   These symptoms may be distorted vision, blurred vision, or a defect in your central vision. VMA that goes untreated can lead to the development of further complications such as worsened vision, macular hole, ,and/or blindness.

JETREA® (ocriplasmin) is an FDA approved pharmacological treatment for symptomatic VMA.  It is a clear, colorless solution that is injected into the vitreous of your eye.  This medication is designed to dissolve the protein matrix that causes VMA.

ALTERNATIVES

You do not have to undergo treatment with JETREA®. Alternatives to injection with JETREA are explained below.

Until the availability of JETREA, the standard of care in the treatment of mild to moderate symptomatic VMA in patients has been “watchful waiting.” In symptomatic VMA patients with more significant vision loss, the standard of care is vitrectomy, which involves surgically removing the vitreous from the eye, thereby  releasing the symptomatic VMA.

If you have symptomatic VMA needing the vitrectomy procedure and do not have it done , your symptomatic VMA can worsen, possibly leading to permanent vision loss.

HOW WILL THIS TREATMENT AFFECT MY VISION AND/OR CONDITION?

There is no guarantee that the injection with JETREA®  will improve your condition. Sometimes it doesn’t work. In addition, this treatment and/or the injection procedure may cause some side effects. The injection procedure may cause intraocular inflammation, infection, or hemorrhage.  It could also result in eye pain or increased intraocular pressure.  . 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 this treatment with JETREA® to help you decide whether you are ready to accept the risks.

Possible complications and side effects of the procedure and administration of JETREA®  

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.

• Decreased Vision- The majority of these decreases in vision were due to progression of the condition with traction and many required surgical intervention.
• Intraocular inflammation/ infection, intraocular hemorrhage and increased intraocular pressure (IOP). Most of the post-injection intraocular inflammation events were mild and transient.
• Potential for Lens Subluxation- (displacement or malpositioned lens within the eye)
• Dyschromotopsia- generally described as yellowish vision, some with electroretinograph (ERG) changes reported
• Retinal detachment or retinal tear
• Cataract formation (clouding of the lens of the eye)
• Hypotony (reduced pressure in the eye)
• Damage to the retina or cornea (structures of the eye)
• There is also the possibility of an eye infection (endophthalmitis)
• Patients may experience temporary visual impairment after receiving an intravitreal injection of JETREA

The most common adverse reactions (incidence 8% – 20%) with JETREA were vitreous floaters, conjunctival hemorrhage (bleeding within the outside lining of the eye), eye pain, photopsia (flashes of light), and blurred vision.

 PATIENT RESPONSIBILITIES

I will immediately contact my ophthalmologist if any of the following signs of infection or other complications develop:  eye becomes red, sensitive to light, painful, or develops a change in vision. I have been instructed NOT to rub my eyes or swim for three days after the injection.  I will keep all post-injection appointments or scheduled telephone calls so my doctor can check for complications.

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 receiving JETREA® for symptomatic VMA. I have been offered a copy of this document.

Patient (or person authorized to sign for patient)                             Date