Meibomian Gland Dysfunction (MGD)

Dry Eye

Dry Eye is more than an inconvenience. Dry Eye is a disease. Many people suffer for years from the discomfort and pain of Dry Eye Disease. Most try various products to manage their disease, and while many of the Over-The-Counter products can provide relief, it is just temporary symptom relief.

Meibomian Gland Dysfunction (MGD) is a leading cause of Dry Eye Disease. 86% of dry eye patients have MGD,¹and yet it is very often overlooked.

What Is Meibomian Gland Dysfunction Or MGD?

Healthy meibomian glands that line your upper and lower eyelids secrete oil with every blink. This oil, or lipid, serves as a critical component of a healthy tear film in that it helps prevent tear film evaporation. When the glands are not functioning correctly, it is called Meibomian Gland Dysfunction, or MGD. MGD is a leading cause of Dry Eye Disease and can be the source of dry eye symptoms, such as burning, stinging, and itching. However, even patients without symptoms (asymptomatic) could have MGD.

Introducing LipiFlow®

The appropriate treatment for your Dry Eye will depend on what is causing your condition, and may include:

Possibly treatments for Dry Eyes are prescription eye drops for aqueous deficient dry eye, thermal pulsation treatments, omega-3 supplements, and warm compresses for MGD, punctal plugs, etc.

If you have MGD, LipiFlow® is an automated treatment that helps clear away gland obstruction and restore gland function.⁴ The treatment is routinely performed in a single office visit, and takes only 12 minutes, but the results could last for up to twelve months.⁵

With more than 400,000 treatments worldwide and growing,⁶ patients just like you are experiencing the proven benefits of the LipiFlow ® Thermal Pulsation System:²

LipiFlow® is a safe and designed to be a comfortable, FDA-cleared⁷, in-office⁴ treatment for the inner and outer lid treatment of MGD.
After an initial anesthetic eye drop, LipiFlow® applies precise heat to the inner eyelids and gently massages the Meibomian glands to loosen the oil trapped within the glands.
Once loosened, LipiFlow® then pushes the contents up and out while protecting the delicate structure of the eyelids.
This treatment is designed to restore the natural oil flow to the tear film that covers the eye’s surface.

REFERENCES:

Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012;31(5):472-478. 2. Nichols KK, Hanlon SD, Nichols JJ. A murine model for characterizing glandular changes in obstructive Meibomian gland dysfunction. ARVO. 2014. Abstract #13-A0002. 3. Schaumberg DA, Nichols JJ, Papas EB, et al. The international workshop on Meibomian gland dysfunction: report of the subcommittee on the epidemiology of, and associated risk factors for, MGD. Invest Ophthalmol Vis Sci. 2011;3:52(4):1994-2005. 4. LipiFlow® Thermal Pulsation System Instructions For Use. 5. Blackie CA, Carlson AN, Korb, DR. Treatment for Meibomian gland dysfunction and dry eye symptoms with a single-dose vectored thermal pulsation: a review. Curr Opin Ophthalmol. 2015;26(4):306-13. 6. Data on file. 7. K161357, 510K Summary. Content courtesy of Johnson & Johnson Surgical Vision, Inc.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for LipiFlow® Thermal Pulsation System

INDICATIONS: The LipiFlow® Thermal Pulsation 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. CONTRAINDICATIONS: 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. Ocular surgery within prior 3 months, including intraocular, oculo-plastic, corneal or refractive surgery procedure. Ocular injury within prior 3 months. Ocular herpes of eye or eyelid within prior 3 months. Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye). Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis). Eyelid abnormalities that affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis). Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy). WARNINGS: Caution: Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of the device by children or incapacitated persons may be dangerous. PRECAUTIONS: The Activator or Activator II (Disposable) may not fit all eyes, such as eyes with small palpebral fornices. Use of the LipiFlow® System in patients with the following conditions may result in reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands and require other medical management. Safety and effectiveness of the device have not been studied in patients with these conditions. Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis. Severe (Grade 3 or 4) eyelid inflammation (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis). Patients with severe eyelid inflammation should be treated medically prior to device use. Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener’s granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjögren’s syndrome). Taking medications known to cause dryness (e.g., isotretinoin (Accutane®) and systemic antihistamines). Esthetic eyelid and eyelash procedures (e.g., blepharoplasty, lash extensions, eyelid tattooing). In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms. 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 the treatment procedure; Eyelid irritation or inflammation (e.g., edema, bruising, blood blister, dermatitis, hordeolum or chalazion); Ocular surface irritation or inflammation (e.g., corneal abrasion, conjunctival edema or conjunctival injection (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 intervention 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. ATTENTION: Reference the LipiFlow® Thermal Pulsation System Instructions for Use for a complete listing of indications, warnings, and precautions.

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