Many commonly attribute their eye discomfort to dry eye, when a leading cause of the burning, scratching and redness is Meibomian Gland Dysfunction or MGD.
MGD occurs when there is a compromise to the function and/or structure of the Meibomian glands. These glands, located in the eyelids, produce the protective oily (lipid) layer of the tear film. This oil helps protect the surface of the eye from disease and prevents the watery part of the tears from evaporating when your eyes are open. Without these oils, the eyes become more susceptible to the negative effects that dry climates, air conditioning, computer use, reading and other daily activities can have on the long-term health of our eyes.
LipiFlow® is a treatment performed in your doctor’s office designed to remove blockages from the Meibomian glands, allowing them to properly function and produce the oils that make up the top protective lipid layer of the tear film. LipiFlow® is supported by more than 30 patents with studies demonstrating its safe and effective results.1 It is designed to minimize patient discomfort during a 12-minute treatment that gently massages the eyelids.
LipiFlow® Activators are single-use sterile devices that safely and comfortably deliver a combination of heat to the inner lids and simultaneous therapeutic motion to the outer lids, removing blockages from the Meibomian glands.1 The Activators are contoured to avoid contact with the cornea, protecting the delicate structures of the eye.
Once the gland blockages are removed, the glands can resume normal oil or lipid production. This oil is essential for a healthy tear film, providing stable vision and ocular comfort. As normal gland function recovers, maximum results are usually experienced 6-8 weeks after treatment.
INDICATIONS FOR USE
The LipiFlow® System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including Meibomian Gland Dysfunction (MGD), also known as Evaporative Dry Eye or Lipid Deficiency Dry Eye.
Do not use the LipiFlow® System in patients with the following conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions.
The Activator or Activator II (Disposable) may not fit all eyes, such as small eyes (eyes with small palpebral fornices).
Use of the LipiFlow® System in patients with the following conditions may result in reduced treatment effectiveness because the conditions may cause ocular symptoms unrelated to cystic meibomian glands. Safety and effectiveness of the device have not been studied in patients with these conditions.
In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.
POTENTIAL ADVERSE EFFECTS
Potential adverse effects that may occur as a result of the procedure include, but are not limited to the onset or increase in: eyelid/eye pain requiring discontinuation of treatment procedure; eyelid irritation or inflammation [e.g., swelling (edema), bruising, blood blister, skin irritation (dermatitis), stye (hordeolum or chalazion)]; ocular surface irritation or inflammation [e.g., scratch on the eye surface (corneal abrasion), eye swelling (conjunctival edema) or eye redness (conjunctival injection or hyperemia)]; and ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light).
Potential serious adverse events (defined as permanent impairment or damage to a body structure or function or necessitates medical or surgical treatment to preclude permanent impairment or damage to a body structure or function) that are not anticipated because of the device mitigations to prevent occurrence include: thermal injury to the eyelid or eye, including conjunctiva, cornea or lens; physical pressure-induced injury to the eyelid; and ocular surface (corneal) infection.