Macugen™ Consent Form

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PLACE LETTERHEAD HERE AND REMOVE NOTE.  

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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.

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

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PLACE LETTERHEAD HERE AND REMOVE NOTE.  

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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 2/22/2006

Informed Consent for DSEK

Descemet’s Stripping Endothelial Keratoplasty

I have been informed by my physician that I am a candidate for a corneal transplant operation.  This consent form is designed to educate me about the various options available to me.  It is intended to make me better informed about the risks, benefits, and alternatives of traditional corneal transplant surgery (a penetrating keratoplasty), versus the DSEK, the Descemet’s Stripping Endothelial Keratoplasty.

INDICATIONS FOR CORNEAL TRANSPLANT SURGERY

The human cornea is composed of three layers, the outer or epithelial layer, the middle or stromal layer (which comprises about 90% of the total corneal thickness), and the inner or endothelial layer.  The endothelial layer is composed of a single layer of thousands of small pump cells.  These endothelial pump cells are responsible for pumping fluid out of the cornea so it can remain clear and thin and provide good vision for the eye.  If the pump cells should become dysfunctional, damaged, or destroyed, the corneal fills up with fluid and becomes swollen and cloudy, and causes blurry vision.

The endothelial cells can be lost due to aging, from inherited diseases (such as Fuchs’ Corneal Dystrophy), from trauma, or from previous intraocular surgery.  If a critical number of endothelial cells are lost, and the cornea becomes swollen and cloudy, medical therapy is usually not helpful and a corneal transplant operation is indicated.  The remainder of the corneal layers, the stroma and the outer epithelium, are usually healthy.  A large number of patients requiring corneal transplant surgery have these sorts of problems where only the endothelial cells have been or injured or lost.

ADVANTAGES AND DISADVANTAGES OF TRADITIONAL TECHNIQUE

Standard corneal transplant surgery has consisted of removing the entire cloudy cornea and replacing it with a full thickness donor cornea, thereby replacing all three layers of the cornea.  This surgery was first developed one hundred years ago, and the wonderful 90% success rate reported today is based on numerous refinements to this same basic technique.   It has certainly stood the test of time.

Ophthalmic researchers and surgeons have long recognized that for many patients needing a corneal transplant, only the diseased or missing endothelial cells needed to be replaced, as the stroma and epithelial layers were otherwise normal.  Recently, a new technique called DSEK has evolved in corneal transplant surgery which accomplishes the goal of replacing only the endothelial cell layer.  A thin button of donor tissue containing only the endothelial cell layer is inserted onto the back surface of the patient’s cornea.  This new technique appears to be a significant improvement over the standard operation.  The surgical skill and expertise required is the same, but the surgery itself takes less time with an experienced surgeon, involves a smaller surgical incision, requires far fewer sutures, heals faster and more reliably, and the vision returns faster. 

The advantage of the traditional corneal transplant operation is the long and successful track record that we have with it.  There is a 90% success rate.  The rate of rejection is only about 8%.  It is relatively easy to combine other surgery with it such as cataract extraction or glaucoma surgery.  The disadvantages of the traditional corneal transplant operation are the time involved in performing the actual operation (45 to 60 minutes), the difficulties in suturing the new cornea in place, and occasional problems with the sutures which can come loose, cause infections, or cause astigmatism (an irregular corneal shape) .  The astigmatism after traditional corneal transplant surgery can be so significant that eyeglasses alone won’t give adequate vision and some patients ultimately require contact lenses or additional surgery to reduce or eliminate the astigmatism.  Because the wound is a full 360 degrees, and the sutures used are finer than human hair, the corneal transplant wound is always very delicate and at risk to rupture or break open from mild or incidental trauma, even several years after the surgery.  The visual recovery can take 6 to 12 months.

ADVANTAGES AND DISADVANTAGES OF DSEK TECHNIQUE

There are several significant advantages to the DSEK operation compared to the standard corneal transplant operation.  Once the surgeon is skilled in the technique, the operation is faster.  The wound is smaller and closer in size and location to a cataract surgery incision.  The smaller wound is more stable and less likely to break open from inadvertent trauma.  Because the wound is smaller and requires far fewer sutures, there is very little postoperative astigmatism which can delay the visual recovery.  The maximum return in vision takes only about 3 to 4 months following DSEK.  Since only the thin inner layer of the cornea is replaced, over 90% of the patient’s own cornea remains behind contributing to greater structural integrity and a reduced incidence of rejection. 

DSEK is not for everyone.  Some patients with corneal scarring or other conditions are not suitable candidates for DSEK.  There are risks involved with the DSEK operation.  Since corneal specialists have only been performing DSEK for the past 2 to 3 years,  there is no long-term follow-up.   There is a risk of the thin button of endothelium becoming displaced within the first few days or weeks after surgery and requiring a return trip to the operating room to reposition it.  If the DSEK operation fails, the operation can be repeated with another button of donor endothelium.  If the DSEK fails, either after one or multiple attempts, a traditional corneal transplant operation can be performed.

RISKS AND COMPLICATIONS OF DSEK CORNEAL TRANSPLANT SURGERY

The general risks of the DSEK that are similar to the traditional corneal transplant operation include the risk of hemorrhage in the eye, infection, 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 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.

I understand that there may be other unexpected risks or complications that can occur that were not listed in the consent form or discussed by the doctor.  I also understand that during the course of the proposed operation unforeseen conditions may be revealed that require the performance of additional procedures, and I authorize such procedures to be performed.  I further acknowledge that no guarantees or promises have been made to me concerning the results of any procedure or treatment.

PATIENT CONSENT

I have had ample opportunity to read this consent form, ask questions of my surgeon, and have been offered a copy of this consent form to take home.  I voluntarily give my authorization and consent to the performance of the procedure(s) described above (including the administration of blood and disposal of tissue) by my physician and/or his associates, assisted by hospital or surgery center personnel and other trained persons.

In signing this informed consent for DSEK corneal transplant surgery, I am stating that I have been offered a copy, I fully understand the possible risks, benefits, and complications of DSEK corneal transplant surgery, and

• I have read this informed consent _________ (patient initials)
• The consent form was read to me by _______________________________ (name).

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

_____________________________________                                     ________________

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

______________________________________

Print patient’s name

Version 2/22/06

Pterygium Consent Form

INFORMED CONSENT FOR PTERYGIUM EXCISION

WHAT IS A PTERYGIUM?

Pterygium (pronounced tur-IJ-ee-um) is a growth on the cornea (the clear front window of the eye) and the conjunctiva – the thin, filmy membrane that covers the white part of your eye (sclera).  These growths are believed to be caused by dry eye, exposure to wind and dust and UV (ultra-violet) exposure.

WHAT ARE TREATMENT ALTERNATIVES?

In many cases no treatment is needed. Sometimes eyedrops and ointments may be used to reduce inflammation (swelling). If the growth threatens sight or causes persistent discomfort, it can be removed. You should understand that despite proper surgical removal, the pterygium may return. If a pterygium returns, additional surgery may be necessary, particularly if there is persistent inflammation or progression of the new growth towards the center of vision.

HOW WILL REMOVING THE PTERYGIUM AFFECT MY VISION?

The goal of pterygium excision (removal) is to decrease irritation/inflammation, achieve a normal, smooth ocular surface, improve the decreased vision caused by the pterygium, and prevent regrowth, if possible.

WHAT IS MITOMYCIN-C?

Mitomycin-C (MMC) may be used during excision (removal) to minimize the recurrence of pterygium.  MMC was first used as anti-cancer drug. Ophthalmologists use MMC for other purposes “off-label” as part of the practice of medicine*. The decision to use MMC is based on the evaluation of the advantages and potential disadvantages in each individual case.

WHAT IS AMNIOTIC MEMBRANE GRAFTING”?

When a pterygium is large, inflamed, recurrent, or for other indications, amniotic membrane grafts** can be used to aid healing of the wound and reduce inflammation that can lead to recurrence.  It may be used in selected cases for the management of both primary and recurrent pterygium to aid in rapid healing with reduced inflammation, scarring and unwanted blood vessel formation.

WHAT IS CONJUNCTIVAL TRANSPLANTATION?

Conjunctival transplantation moves a piece of your own conjunctiva (filmy white part of the eye) to the area where the pterygium is excised (removed). This technique may be used for the management of both primary and recurrent pterygium.

WHAT ARE THE RISKS OF PTERYGIUM EXCISION?

All operations and procedures are risky and can result in unsuccessful results, complications, and injury from both known and unknown causes. Complications that may occur days, weeks, or even months later include but are not limited to: poor vision; loss of corneal clarity; bleeding; infection; double vision  and injury to parts of the eye and nearby structures from the procedure or anesthesia.  The pterygium may grow back.  You may need additional treatment or surgery to treat these complications.

In addition to the usual complications of pterygium excision, Mitomycin-C may cause blurred vision, worsened or loss of vision, ocular pain, ocular surface irritation, sensitivity to light, delayed healing, scleral or corneal melt with perforation, scarring of the conjunctiva or cornea, iritis, glaucoma, cataract, and possible need for further eye surgery.

PATIENT’S ACCEPTANCE OF RISKS

I have read the above information and have discussed it with my physician. 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 and that I understand and accept the risks, benefits, and alternatives of pterygium excision.  I consent to the removal of a pterygium on my ___________________ (state “right” or “left”) eye.

____________________________________________

Patient (or person authorized to sign for patient)                          Date

* FDA STATUS OF MMC IN EYE SURGERY

MMC was approved by the Food and Drug Administration (FDA) for the treatment of various types of cancer.  Upon approval, the drug manufacturer produces a “label” that explains its use.  Once a drug is approved by the FDA, physicians can use it for other purposes “off-label” as part of the practice of medicine if they are well-informed about the product, base its use on firm scientific method and sound medical evidence, and maintain records of its use and effects.

**Amniotic Membrane Grafts

The amniotic membrane is the innermost layer of the placenta and enwraps the fetus during pregnancy. This membrane provides a foundation for cells to grow over for a smooth ocular surface.  If this is the treatment option you choose with your physician, you will have a detailed discussion regarding issues related to the use of amniotic membrane tissue.

Keratoprosthesis (Artificial Corneal Transplant) Consent

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INFORMED CONSENT FOR ARTIFICIAL CORNEAL TRANSPLANT (KERATOPROSTHESIS SURGERY)

What is an Artificial Corneal Transplant and Why Do I Need One?

The cornea is the clear front window of your eye.  It functions like a watch crystal.  Many corneal diseases, infections, postoperative complications, and trauma can injure your cornea and make it scarred or cloudy and reduce your level of vision.  Your eye surgeon has determined that you need to have a new cornea to replace  the unhealthy cornea that is currently in place.  There are several reasons why you may need a new cornea:

Complications from LASIK or PRK surgery
Degenerative eye conditions called corneal dystrophies which affect the clarity of the cornea.
Scarring from previous infections, such bacterial, fungal, and viral (e.g. Herpes simplex) infections.
Excessive swelling (edema) of the cornea.
Keratoconus, a condition associated with thinning of the cornea and an irregular shape.
Corneal problems from previous surgeries
Chemical burns on the cornea
Previous ocular trauma.

Patients who need a new cornea often have a surgical procedure called a penetrating keratoplasty (PK), which involves removing a full thickness piece of the patient’s cornea and replacing it with new full thickness piece of corneal tissue.  Sometimes, a DSAEK ( Descemet’s stripping automated endothelial keratoplasty) is performed which involves attaching a thin piece of transplanted cornea to the back of the patient’s existing cornea. Cornea transplants may fail or cause a rejection.

An artificial cornea transplant, or keratoprosthesis, is an option for patients who are not good candidates for a traditional corneal transplant surgery.  The artificial cornea replaces the damaged central cornea with a clear man-made material  that your body is unlikely to reject.

The keratoprosthesis resembles a miniature telescope that is inserted into a corneal transplant and stitched into the patient’s own cornea. The natural lens, if still present, is removed.  If the patient has already had cataract surgery, the lens implant is left alone.  A soft contact lens is then placed onto the eye for comfort and must be worn every day.  If desired, the lens can be colored to match  the color of your other eye. The surgery usually takes about an hour and a half to perform.

ALTERNATIVES  TO ARTIFICAL CORNEA TRANSPLANTSURGERY:

The alternatives are traditional corneal transplants, such as PK or DSAEK, or Phototherapeutic Keratectomy (PTK) performed with the excimer laser.

COMPLICATIONS AND SIDE EFFECTS

There is no guarantee that the surgery will improve your condition. It may fail to improve your vision or even make it worse. In addition, surgery is risky. Sometimes it can make the original 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. In some instances, keratoprosthesis surgery can be repeated.

The risks of artificial corneal transplant surgery with a keratoprosthesis include:

Vitreous hemorrhage- bleeding inside the eye
Endophthalmitis- infection inside the eye
Glaucoma- elevated intraocular pressure
Retroprosthetic Membrane- scar tissue forming behind the keratoprosthesis blocking the vision
Vitritis- sterile inflammation inside the eye
Retinal Detachment- separation of the retina from the wall of the eye resulting in loss of vision
Stromal Melting- thinning or melting of the corneal transplant tissue that holds the keratoprosthesis in place, resulting in loosening or loss of the keratoprosthesis
Ptosis- a droopy eyelid
Loss of vision
Blindness
Injury to other nearby body parts

This document lists the major risks of artificial corneal transplant surgery with a keratoprosthesis to help you decide whether you are ready to accept the risks.

THIS IS AN ELECTIVE PROCEDURE.

You do not have to undergo keratoprosthesis surgery. Alternatives to this surgery have been explained to me.

HOW WILL THE KERATOPROSTHESIS PROCEDURE AFFECT MY VISION AND/OR CONDITION?

The goal of this surgery is to restore clarity and refractive function of the cornea and improve vision.

WHAT TYPE OF ANETHESIA IS USED?  WHAT ARE ITS MAJOR RISKS?

The surgery is performed as an ambulatory procedure under local anesthesia, although general anesthesia may be used on infants and children. There are some risks associated with anesthesia, whether general or local. Complications of anesthesia injections around the eye may include: perforation of the eyeball, injury to the optic nerve resulting in loss of vision, hemorrhage, retinal detachment, interference with retinal circulation resulting in possible vision loss, drooping of the upper eyelid, hypotension or lowering of the blood pressure, and respiratory depression. General anesthesia can result in heart and breathing problems, and in a very unusual and rare instances, death or diminished brain function can occur.

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 the 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 artificial corneal transplant surgery with a keratoprosthesis. I have been offered a copy of this document.

I wish to have an artificial cornea placed in my ___________________________________ (state “right” or “left”) eye.

Patient (or person authorized to sign for patient)                          Date

Surgery Face Sheet

SURGERY FACE SHEET

CASE #:                                                                                                                INS. CO:                                                                               

AUTH #:                                                                               PATIENT NAME:                                                                              

SURGERY DATE:                                                             SURGERY TIME:                               AM        PM

PLACE OF SERVICE/HOSPITAL:                                                                                                                

TYPE OF SURGERY:                                                                         OD         OS           PATIENT AGE:                  

ANESTHESIA:                    L.S.B.     GENERAL            DIABETIC           YES        NO

COUMADIN:       YES        NO

ANESTHSIA GROUP:                                                                                      

PRIMARY CARE PHYSICIAN:                                                                                                                                     

PRE-OPT APPT. DATE:                                                                                     TIME:                                                   

POST-OP APPT. DATE:                                                                                     TIME:                                                   

KERATOTOMY          QUALITY OF KERATOTOMY:              GOOD                    AVG                       POOR

OD                                  X                             @            OD

                                                                                X                             @            AVG:                      X                            

                                                                                                X                             @           

                                                        OS                                   X                             @            OS

TECHNICIAN                                                     X                             @            AVG:                     X                            

                                                                                                X                             @           

INFORMED CONSENT GIVEN:     YES        NO          PRE-OP INSTRUCT GIVEN:           YES        NO

ACTIVITY SHEET GIVEN:             YES        NO          POST-OP INSTRUCT GIVEN:         YES        NO

INFORMED CONSENT DISCUSSED (INCL SPECIAL RISKS):                                                                                            

A-SCAN (SCANS STAPLED ON BACK)

                OD:                                                         QUALITY OF SCAN:         GOOD                    AVG                       POOR

                OS: