Risk Management

Punctal Plugs Consent Form (Courtesy of Bernard H. Chang, MD, a practicing ophthalmologist in Nashville, TN.)

REMOVE NOTE AND PUT ON LETTERHEAD
CHANGE FONT SIZE FOR LARGE PRINT
Please review the form, modify it to fit your actual practice, and place on your letterhead.  Please offer the patient a copy of the form. The last page serves to verify that the surgeon has obtained informed consent from the patient; it can be copied and sent to the ambulatory surgery center if needed as verification of consent. This consent form is intended as a sample only and is provided as a risk management service.  It is not intended to constitute a standard of care and should not be relied upon as a source for legal advice.  If legal advice is desired or needed, an attorney should be consulted.
Version 4/19/06
Punctal Plugs Consent Form

Condition and Proposed Treatment
My ophthalmologist has diagnosed me with dry eye syndrome. Typical symptoms of this condition include burning and (paradoxically) watering and a sensation like something is in the eye. In many cases dry eyes are caused by the body’s failure to produce enough tears. Blocking the tear drainage system with punctal or intracanalicular (tear duct) plugs may improve symptoms by keeping more tears in the eye. Severe cases of dry eye may lead to infection and in rare cases, blindness or loss of the eye.

Alternatives
1.    Artificial tears or ointment – Lubrication increases moisture on the surface of the eye.  Depending on severity, these over-the-counter drops and ointments may be applied several times daily for maximal comfort
2.    Restasis – Used twice daily, this prescription eye drop increases production of the body’s own tears.
3.    Surgical tear drainage closure – The punctum and canaliculus may be surgically occluded by thermal cautery (heat) or ligation (suture closure).  These methods should be considered permanent.
4.    No Treatment – I may choose to do nothing and tolerate the symptoms of my dry eye condition.

Risks
1.    Infection –  The punctal plug is a foreign material and may be associated with infection around the plug.  Infections can be treated with antibiotics and removal of the plug.
2.    Excessive Tearing – In some cases, plugs may cause an overflow of tears.  Your doctor may decide to remove the plugs in this situation.
3.    Irritation – The exposed end of the punctal plug may cause irritation and need to be replaced with a different size plug or removed.
4.    Loss of the Plug – The punctal plug may fall out or need to be replaced.
5.    Retention of plug in or permanent scarring of the tear duct – Although rare, plugs may become lodged in the tear drainage pathway (canaliculus) or cause scarring.  Surgery may be necessary to re-establish tear drainage

Consent For Treatment
By signing below, I acknowledge that I have read and understand the above and have had the opportunity to discuss this information with my doctor to my satisfaction.  I consent to the insertion of punctal plugs in the (PLEASE CIRCLE)

RIGHT   lower    upper     LEFT    lower   upper eyelid(s)

____________________________________        ____________________
Patient Signature                        Date