Risk Management

LipiFlow Consent Form

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: