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INFORMED CONSENT FOR OPEN GLOBE INJURY (OGI) INITIAL REPAIR

(Repair of cut to or rupture of the eyeball

WHY MIGHT I NEED REPAIR OF THE INJURY TO MY EYE?

The cornea is the clear front window of the eye and the sclera is the white part of the eye. A laceration is an injury, like a cut, partially or fully through the cornea or sclera (the eyeball). Rupture of the eyeball can be caused by significant blunt force to the eyeball, such a sports ball or fist hitting the eye, or a sharp object. Full-thickness lacerations and ruptures are known as open globe injuries (OGIs). Without repair of the wound, there is a high chance of infection, severe or total loss of vision, and cosmetic disfigurement. Many OGIs result in the contents of the eye (iris, lens, vitreous gel, and retina) being pushed out of the eye. If not replaced into the eye or excised, the wound cannot heal and function is lost. In some cases of lacerations, a foreign body may enter and remain in the eye. If not removed, foreign bodies can harbor infection, damage the inside of the eye by moving around, and release substances toxic to the eye. Eye injuries can be associated with injuries to the surrounding eye muscles, bony structures around the eyewall, the nerve responsible for vision (the optic nerve), and facial structures. Other major consequences and risks of OGI include:

Infection, which can lead to severe damage inside the eye and total loss of vision and of the eye
Bleeding inside the eye, which can cause permanent vision loss and may require surgery
Loss of ocular contents (iris, lens, vitreous gel, and retina), which can be pushed out of the eye by the initial trauma or, after the initial trauma, by lid squeezing or eye rubbing
Loss of portions of the eye (cornea and sclera), which may require grafts or removal of the eyeball
Retinal tears and detachment, which may require laser treatments or additional surgery, or may be too severe to repair, leading to permanent loss of vision
Retinal swelling (cystoid macular edema), which may require eye drops or injections
Glaucoma (elevated pressure inside the eye, which may lead to loss of vision by damaging the optic nerve (the nerve responsible for eyesight), and which may require eye drops, laser treatment, or surgery
Poorly healing or non-healing wounds, which may require additional surgery
Corneal clouding and scarring, which may require additional surgery
Cataract (clouding of the natural lens), which may require immediate or eventual removal of the lens
Double vision, which may require prism glasses or eye muscle surgery
Eyelid cosmetic deformity, such as a droopy eyelid, which may require surgery
Loss of blood circulation to vital tissues in the eye, which may result in a decrease or loss of vision
Damage to the optic nerve (the nerve responsible for vision) with loss of vision
Phthisis (disfigurement and shrinkage of eyeball) which may require a cosmetic contact lens or removal of the eyeball if painful and can lead to asymmetry/cosmetic deformity

For some patients, the traumatic episode, changes in vision and appearance, and the often prolonged course of medical management may lead to anger, anxiety, depression, or other normal but severe emotional reactions. If these occur, it is important to seek treatment, reach out for support, and develop coping skills. Additionally, it is very important to assure protection and routine evaluations of the non-injured eye.

Initial surgical repair is intended to prevent further damage to the eye, prevent infection, and provide the best chance at restoring vision and cosmetic appearance.

HOW IS THE INITIAL OPEN GLOBE INJURY (OGI) REPAIR (SURGERY) DONE?

Initial OGI repair is performed in an operating room under anesthesia.

If there is hope of improving or restoring vision and maintaining cosmetic appearance, the surgeon will attempt to close the laceration/rupture at the initial OGI repair. Stitches will be placed to close the eyeball (restore its integrity). Your doctor will choose the best type of stitches for your specific wound and depending on the type used, they will be removed later or may dissolve on their own. Foreign bodies may be removed at the time of initial surgery, especially if protruding from the eye. In some situations, in which it is not safe to remove foreign bodies at the initial OGI repair, foreign bodies may be left for removal at a later date by a retina surgeon. Ocular contents that have been pushed out from inside the eye may be put back into the eye or removed, depending on the circumstances.

In rare cases where the eye is damaged beyond repair and there is no chance of saving any vision, your doctor will remove the hopelessly damaged eyeball, instead of trying to repair it, to prevent or reduce the risk of infection, cosmetic disfigurement, chronic pain, or a very rare condition in which inflammation attacks the non-injured eye.

Severe injuries may require more than one operation to restore vision and improve cosmetic appearance. Initial OGI repair may be the first of many steps in a series of medical and surgical interventions to restore structure and function. Even with multiple surgeries, severe injuries can result in vision loss and cosmetic deformity.

HOW WILL THE INITIAL OPEN GLOBE INJURY (OGI) REPAIR AFFECT MY VISION OR APPEARANCE?

The results of the initial repair of the OGI depend upon the severity and location of the injuries. Initial OGI repair is intended to restore the integrity of the eyeball, prevent infection, prevent further injury, and, in doing so, maximize the chances of eventual visual and cosmetic improvement. Initial OGI repair may or may not by itself improve vision or cosmetic appearance.

Some patients have unrealistic expectations about how open globe injury repair will impact their lives. Even in the hands of the best surgeons, some injuries are so severe and extensive that vision may be permanently impaired or even completely lost and the injured eye may eventually need to be removed. You should carefully understand the severity of the injury, the risks of the repair, and ask questions before agreeing to surgery.

WHAT ARE THE MAJOR RISKS OF THE INITIAL REPAIR (SURGERY) FOR OPEN GLOBE INJURY (OGI)?

The intent of initial repair of the OGI is to restore the integrity (seal the open defect) of the eyeball to prevent infection and maximize visual and cosmetic recovery. The full extent of damage to the eye and surrounding structures may not be apparent before and during initial OGI repair. Damage from the initial trauma, even if it only becomes apparent after initial OGI repair, is not a complication of the initial surgery.

Risks of initial OGI repair include all the consequences of the OGI (listed above in the section WHY MIGHT I NEED REPAIR OF THE INJURY TO MY EYE?) and, in particular, bleeding, infection, permanent vision loss, inflammation of the uninjured eye, and loss of the eye. Due to individual differences in severity of injury and variable wound healing, no guarantees can be made as to your final result.

WHAT ARE THE ALTERNATIVES?

The alternatives are to not have surgery or to delay surgery. If you delay or do NOT have surgery to close the OGI, you have a much higher risk, and in some situations are guaranteed, to lose some or all vision permanently and/or to suffer from permanent cosmetic deformity. Ideally, initial surgical repair is performed soon after the injury to minimize the risk of further damage and infection.

WHAT TYPE OF ANESTHESIA IS USED? WHAT ARE THE MAJOR RISKS?

Most eyeball trauma repair surgeries are performed under anesthesia with you partially or completely asleep. Risks of anesthesia include but are not limited to damage to the eye and surrounding tissue and structures (from the numbing shots), loss of vision, infection, damage to mouth and/or breathing structures, breathing problems, and, in extremely rare circumstances, stroke or death. The anesthesiologist will review the specific risks of the type of anesthesia you will have with surgery.

PATIENT’S ACCEPTANCE OF RISKS

By signing below, you agree that:

You have read (or someone read to you) the above information and you have discussed it with your doctor
_______________________ has answered all of your surgical questions and has encouraged you to ask any questions prior to surgery
It is impossible for your doctor to inform you of every possible complication that may occur with the initial open globe injury repair
Your doctor has told you that results cannot be guaranteed, and that adjustments and/or more surgery may be necessary
You understand the risks, benefits, and alternatives to open globe injury repair
You feel able to accept the risks involved

I consent to open globe injury repair surgery on my (write “right”, “left”, or “both”) eye/eyes:

X_____________________________________________ ________________________

Patient (or person authorized to sign for patient) Date and time

Physician Declaration: The contents of this document have been explained to the patient and all questions and concerns have been answered. To the best of my knowledge, I feel that the patient has been adequately informed and has consented.

X_____________________________________________ ________________________

Physician Date and time

Addendum

INFORMED CONSENT FOR SURGERY TO DETERMINE IF THERE IS AND OPEN GLOBE INJURY (OGI) AND TO PERFORM INITIAL REPAIR OF A CUT TO OR RUPTURE OF THE EYEBALL

WHY MIGHT I NEED SURGERY (EYEBALL EXPLORATION) TO DETERMINE THE EXTENT OF THE INJURY TO MY EYE?

The cornea is the clear front window of the eye and the sclera is the white part of the eye. A laceration is a cut, usually caused by a sharp object such as glass or metal, partially or fully through the cornea or sclera (the eyeball). Rupture of the eyeball can be caused by significant blunt force to the eyeball, such as a sports ball or fist hitting the eye. Full-thickness lacerations and ruptures are known as open globe injuries (OGIs). Without repair of the wound, there is a high chance of infection, severe or total loss of vision, and cosmetic disfigurement.

Your doctors have used all available means (e.g. physical examination) to determine if you have an OGI, but have been unable to exclude the possibility that you have an OGI. There is enough of a chance that you may have an OGI that your doctor recommends that you have a surgical exploration of the surface of the eyeball in the operating room. This will require opening the tissue around the eye to allow examination of the back portion of the eyeball.

HOW IS THE EYEBALL EXPLORATION DONE?

Eyeball exploration to look for an open globe injury (OGI) is performed in an operating room under anesthesia. The surgeon will surgically open the soft tissue around the eye to expose and visually inspect the back parts of the eyeball. If an OGI is found, your physician will proceed to INITIAL OPEN GLOBE INJURY (OGI) REPAIR (SURGERY) to prevent further damage to the eye, prevent infection, and provide the best chance at restoring vision and cosmetic appearance.

Lid Laceration Repair Consent Form and Addendum

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LID LACERATION REPAIR CONSENT 5 12 2019

INFORMED CONSENT FOR EYELID LACERATION REPAIR

(“Repair of cut to the eyelid”)

WHY MIGHT I NEED REPAIR OF THE CUTS ON MY EYELIDS?

The eyelid is a multilayered structure that covers and protects the eye. It contains muscles that open and close the eye. The eyelids function to protect the eye and keep out foreign material as well as to regularly spread tears on the surface of the eye to keep it moist and then drain away the tears. The tears are produced by the lacrimal (tear) gland located in the eye socket in the upper outer corner on both sides. The tears are secreted onto the eyeball and drain through small holes in the inner corner of the eyelids into the nose and throat through the tear drain system. If the tear drain system has been damaged by the laceration, it may scar shut (become blocked) so that tears cannot drain into the nose. The tears will then run down your face (as if you were crying).

A laceration is a cut that can go partly or fully through the eyelid. Lacerations to the eyelid can severely affect the ability of the eyelids to maintain their function. The goal of eyelid laceration repair is to improve the appearance and function of the eyelid, protect the eyeball, reduce discomfort and irritation, reduce tearing and discharge, and reduce the risk of infection.

HOW IS EYELID LACERATION REPAIR DONE?

Repair of cuts to the eyelids is often done in an operating room with the patient under anesthesia, but might be done in the emergency department of the hospital or even the doctor’s office if the cuts are not severe. You and your doctor will decide which location is best for you. The doctor will often use sutures (stitches) or sometimes glue to close the wound. Again, you and your doctor will decide what materials are needed to give you the best result.

The ophthalmologist (eye surgeon) may test the tear drain to find out if and where it has been cut. If the tear drain has been cut, a flexible tube may be inserted into the tear drain during the repair and left in place for a few months (sometimes longer) to keep the drain open. Later, this tube can be removed in the office.

HOW WILL EYELID LACERATION REPAIR SURGERY AFFECT MY VISION OR APPEARANCE?

The results of eyelid laceration repair surgery depend on the severity and location of damage (which parts of the eyelid are cut), symptoms, individual anatomy, and appearance goals. Eyelid laceration surgery is not considered cosmetic surgery, but most patients feel that they look better after the surgery than they did with the cuts. Eyelid laceration surgery does not improve blurred vision caused by problems inside the eye, or by vision loss caused by injuries to the eye ball, muscles that move the eye, or nerve damage behind the eye and does not repair paralyzed/injured nerves. Eyelid surgery cannot repair all problems associated with trauma to the face and/or eye.

It is important to understand that some patients have unrealistic expectations about how eyelid laceration surgery will impact their lives. Carefully evaluate your goals and your ability to deal with changes to your appearance before agreeing to this surgery. Understand the risks and ask questions of your doctor.

WHAT ARE THE MAJOR RISKS?

Risks of eyelid laceration surgery include but are not limited to: bleeding, infection, scarring, an unbalanced appearance between the eyes, difficulty closing the eyes (which may cause damage to the cornea-the clear covering of the eyeball), drooping of the eyelid(s), double vision, numbness and/or tingling near the eye or on the face, tearing, dry eye, scarring, pain, loss of lashes, poor cosmetic result and, in rare cases, loss of vision. If the tear drain has been cut, even after repair it may not stay open and may require additional surgery to correct. You may need additional treatment or surgery to treat these complications; the cost of the additional treatment or surgery is NOT included in the fee for this surgery. Due to individual differences in anatomy, response to surgery, and wound healing, no guarantees can be made as to your final result. For some patients, changes in appearance may lead to anger, anxiety, depression, or other emotional reactions.

WHAT ARE THE ALTERNATIVES?

You may be willing to live with the symptoms and appearance of cuts to your eyelid and decide not to have surgery on your eyelid lacerations at this time (although this is not usually recommended). Cosmetic work may be needed to help the eyelid function or improve your appearance at a later date.

WHAT TYPE OF ANESTHESIA IS USED? WHAT ARE THE MAJOR RISKS?

Most eyelid surgeries are done with some type of anesthesia and/or sedation but this depends on the patient and type of injury. If the cut is small and not severe, you may do well with just local numbing shots. If the cuts are severe, you may be more comfortable completely asleep. Risks of anesthesia include but are not limited to damage to the eye and surrounding tissue and structures (from the numbing shots), loss of vision, infection, damage to mouth and/or breathing structures, breathing problems, and, in extremely rare circumstances, stroke or death. The anesthesiologist will review the specific risks of the type of anesthesia you will have with surgery. If you have surgery in the operating room, the risks will be covered in the anesthesia consent and any questions should be reviewed with the anesthesiologist prior to surgery.

PATIENT’S ACCEPTANCE OF RISKS

I have read the above information and have discussed it with my doctor. I understand that it is impossible for my doctor to inform me of every possible complication that may occur with eyelid laceration repair. My doctor has told me that results cannot be guaranteed, that adjustments and more surgery may be necessary, and that there may be additional costs associated with more treatment. By signing below, I agree that Dr. _______________________ has answered all of my questions and has encouraged me to ask more questions as they arise. I understand the risks, benefits, and alternatives of eyelid laceration repair, and the costs associated with this surgery and future treatment, and I feel I am able to accept the risks involved.

I consent to eyelid repair surgery on:

Right side____ Left side ____ Both sides______

Other: ________________________________________________________________________

X _____________________________________________ ________________________

Patient (or person authorized to sign for patient) Date

X______________________________________________ ________________________

Physician Date

Comanagement consent form

Obtain informed consent for comanaged surgical care

Patients need to know which care will be delegated to a comanaging optometrist. They must be informed that they may contact the ophthalmologist and return to him for care at any time. OMIC advises ophthalmologists who comanage with community optometrists to ask patients to sign Consent for comanagement of surgical patients. Ophthalmologists who comanage with optometrists in their own practice should obtain oral consent and document the patient’s agreement in the medical record. Ophthalmologists in Florida should use the FL comanagement consent form to meet the requirements of state law.

LipiFlow Consent Form

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Download: Lipiflow 2016

LipiFlow® Treatment Of Dry Eye

Dry eye condition can cause eye discomfort and blurred vision. Healthy eyes make a tear film that protects the eyes. The tear film has a water layer, a mucus layer, and an oily layer. Sometimes, the gland that makes the oily layer becomes blocked. Gland blockage is one cause of dry eye condition.

The LipiFlow® System is a medical device that treats dry eye. Your ophthalmologist (eye surgeon) will put numbing drops into your eyes to make your eyes more comfortable. The eye surgeon will then place the device around and behind the eye lids. It rests on the eye like a contact lens to warm and massage the eyelids. This help the oils from the blocked eyelid glands flow into the tear film.

The goal of a LipiFlow treatment is to make your eye more comfortable. Your eye may not feel better the first few weeks. Your eye may not feel completely better if you have some diseases, have had dry eye a long time, or have an eye gland disease. The LipiFlow treatment will help for 9 to 15 months. You may need to have a treatment once a year. Talk to your ophthalmologist about how well LipiFlow will work for you and how often you will need a treatment.

It is your choice to have a LipiFlow treatment. Here are some other options.

Dry eye can damage the surface of the eye if it is not treated, but your eyes may not bother you enough to have treatment.
There are other treatments for dry eye such as eyelid scrub with warm compresses, eye drops, punctal plugs that keep tears in the eye, or surgery to open the tear ducts.

As with all surgery, there are risks (problems that can happen) with LipiFlow. While the eye surgeon cannot tell you about all risks, here are some of the most common or serious:

Eye injury or burn
Eye infection
Eye or eyelid pain
Eyelid irritation (redness, burning, tearing, itching, discharge, foreign body sensation)
Changes in your vision
Sensitivity to light
Stye (a red, sore lump near the edge of the eyelid)
Swelling of the eyelid glands
Scratch on the front of the eye
Swelling of the lining of the eye

Consent. By signing below, you consent (agree) that:

You read this informed consent form, or someone read it to you.
You understand the information in this informed consent form.
The eye surgeon or staff offered you a copy of this informed consent form.
The eye surgeon or staff answered all your questions about LipiFlow.

I consent to have LipiFlow treatment for:

Right eye:_________

Left eye:__________

Both eyes:________

Patient (or person authorized to sign for patient) Date:

Consent for Proxy Forms

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Minor-aged patients are often brought to the pediatrician for non-urgent acute medical care or health supervision visits by someone other than their custodial parent or guardian. These surrogates can be members of the child’s extended family, such as a grandparent, aunt, noncustodial parent, stepparent, au pair or nanny. There are two forms available to assist you with obtaining permission or consent from someone other than the custodial parent or legal guardian.

CONSENT FOR PROXY FOR NON-URGENT PEDIATRIC CARE is available for download (proxy click here).

PREAUTHORIZATION TO TREAT MINORS is available for download (pre-authorize click here).