instrument focus

Going with the Flow

Device treats meibomian gland dysfunction.

Corrie Pelc, CONTRIBUTING EDITOR

For years, the tedious treatment of meibomian gland dysfunction (MGD) has fallen almost exclusively on the MGD patient. The LipiFlow Thermal Pulsation System, from TearScience, Inc., however, has changed this dynamic for the 65% of the more than 100 million dry eye sufferers who have this condition.

Overview

The System is an in-office eyecare practitioner and/or staff-operated device that treats MGD via heat application (42.5° Celsius) and pulsation to the posterior tarsal plate.

Specifically, the System is comprised of an Activator, which is a sterile, single-use biocompatible eye piece connected to a separate wire attached to a console with a graphical user interface. The console is programmed with a preset pressure sequence optimized for complete gland evacuation and to note the treatment time remaining.

“Warm compresses can be less effective due to the wicking effect of the vasculature. When applied from the outside, heat is diverted into the surrounding tissue and away from the affected glands,” says TearScience, Inc. The company adds that on average, patients who underwent the single LipiFlow treatment achieved more than double the meibomian gland score at two weeks vs. those used daily warm compress treatments during this time. Also, gland function continued to improve at the four-week visit beyond two-week improvements, following the treatment.

Dr. Farkas says everyone in whom he's used the System has experienced a diminishing of their symptoms, with the least patients can expect being a lesser need for artificial tears.

The LipiFlow Thermal Pulsation System also enables practitioners to store a record of the treatment on both the device itself and on their EHR's servers, nullifying manual documentation.

Procedure

The practitioner instills a couple drops of proparacaine on the eyes' surface for patient comfort. Then, he/she places the Activator, which delivers the heat. (You can use the System to treat one or two eyes simultaneously.)

An inflatable bladder delivers intermittent gentle pressure to the eyelids' outside surface for 12 minutes per eye, TearScience, Inc. says. The heat works to melt the oils clogging the meibomian glands, while the intermittent gentle pressure aids in removing the obstruction.

So, how does it feel?

“I have had the treatment done myself and found it very comfortable,” says Ritesh Patel, O.D., of the Herzig Eye Institute, Toronto. “Thus far, only one patient has said it's been uncomfortable — he found the lowest pressure too intense — to the point at which I've had to cease treatment.”

Barry Farkas, O.D., of Farkas, Kassalow, Resnick & Associates, in New York, says a majority of his patients have described the treatment as “a day at the eyeball spa.”

The treatment is performed approximately once a year, and clinical trials have shown that the affect can last between nine and 15 months, says Dr. Patel. In the case of more stubborn clogged meibomian gland channels or a still too viscous meibomian production, occasional lid scrubs and hot compresses are continued for a period of time to resolution, says Dr. Farkas. “Although we haven't yet hit that timeframe (the one year mark), we are hopeful that the results will last for at least a year,” he says.

Patient candidacy

TearScience, Inc. says the LipiFlow Thermal Pulsation System shouldn't be used in patients who have undergone ocular surgery, experienced ocular injury, have had an ocular herpes outbreak of the eye or eyelids, an active ocular infection or inflammation or a history of chronic recurrent ocular inflammation all within the prior three months. This is to minimize any potential side effects involving the cornea. Beyond three months, the use of the System is fine.

The company also cautions against using the System on patients who have eyelid abnormalities that affect lid function or who have any ocular surface abnormality that could compromise the cornea's integrity, those who have moderate-to-severe allergic vernal or giant papillary conjunctivitis, severe eyelid inflammation, systematic disease conditions that cause dry eye or who take ocular dryness-causing drugs.

“Of the 400-to-500 eyes on which I've performed the treatment, I've never seen any issues whatsoever,” says Dr. Patel. “I actually performed the treatment on someone who underwent a double corneal transplant, and she was absolutely fine.”

Dr. Farkas adds he's found the LipiFlow Thermal Pulsation System to be a “do-no-harm device.”

Something else worth mentioning: The System's Activator (disposable eye piece) must fit the patient's lids. Dr. Farkas says this has prevented literally “a couple” of his patients from being able to undergo the LipiFlow treatment.

“The eyecups fit 98% of patients, which is great, but I'd really like to see a redesign that would enable all needful patients to undergo the treatment,” he says.

Outcome

Dr. Farkas says everyone in whom he's used the System has experienced a diminishing of their symptoms, with the least patients can expect being a lesser need for artificial tears.

“I recently saw someone who had MGD-caused blepharospasm who had tried every historical treatment with no success,” he explains. “I mean this woman just couldn't stop blinking.”

Dr. Farkas says that when he last saw her, which was at two weeks post undergoing treatment with the System, she had “significantly” less blinking. He adds that he gives all patients a lubricant and an anti-inflammatory for the two-week period following the procedure. For the next month, additional treatment is based on the remaining symptoms and the patient's pre-existing reasons for dry eye other than MGD.

“It (the LipiFlow Thermal Pulsation System) just makes people who have been so uncomfortable for such a long time smile, and it's great to be around happy patients,” Dr. Farkas says.

In terms of potential adverse events, TearScience, Inc. reports the onset of or increase in eyelid pain, eyelid irritation or inflammation, ocular surface irritation or inflammation, ocular symptoms, thermal injury to the eyelid or eye, physical pressure and injury to the eyelid or eye and ocular surface infection.

“The only adverse effect we have had patients experience — and I tell them this ahead of time — is mild ocular redness, which subsides after a couple hours,” says Dr. Patel. “That's it.”

Training

Drs. Farkas and Patel say Tear-Science provides a sales representative who initially spends an afternoon (roughly four hours) training the practitioner and staff on the device, though returns upon request. In addition, they say the LipiFlow Thermal Pulsation System comes with a manual and that the company's chief technical officer and co-founder, Donald Korb, O.D., makes himself available for support.

“TearScience was really handson in wanting to make sure I knew how to operate the System, I was comfortable in doing it, and that my staff and I had the education needed to answer potential patient questions,” says Dr. Patel.

Return on investment

The System costs $100,000 and is a patient out-of-pocket pay treatment in both the U.S. and in Canada. That said, Dr. Farkas, who purchased the device in November, and Dr. Patel, whose practice purchased it in January 2011, say they've achieved a return on their financial investment. Dr. Farkas says that he's received several referrals from primary-care physicians to whom his practice has sent e-mails regarding the System.

Dr. Patel says he charges a $120 initial consult fee and then $750 per eye per treatment, which also includes a follow-up visit. Dr. Farkas says he charges a global fee of $1,900 per eye that lasts for six months. He says he also charges a $150 screening fee, but deducts this from the global fee if the patient proceeds with the treatment.

“Roughly 80% of the patients I've offered the treatment to have opted to undergo it because they are at the point at which they've exhausted the more traditional, less expensive treatments,” says Dr. Patel. “Some of my MGD patients who haven't tried all the traditional therapies have been very gung ho to move ahead with the treatment as well.”

Dr. Farkas says his practice has seen a similar response to the System.

“Our main patients are those who have tried everything else without relief,” he explains. “Though in outlining my step ladder of treatment for MGD, other individuals have said, “I don't want to wait. I want to do it now. We have also had our share of patients going through LipiFlow just to achieve cleaner or more comfortable contact lens wear…'”

He adds that he hopes the device comes down in price because a handful of patients who can benefit from the treatment simply can't afford it right now.

“We've done some procedures at cost for very needful individuals,” Dr. Farkas says.

The ideal practice for the LipiFlow Thermal Pulsation System: large, multi-practitioner practices located in or near metropolitan areas, the doctors say.

“A laser vision correction practice, big contact lens practices and dry eye practices are a natural,” Dr. Farkas says.

Dr. Patel says he feels being able to pull from the Toronto area — home to a population of around five million — allowed his practice to reach a good number of clients.

“When we were looking into (the System) further, we realized there was a big market out there, and patients are demanding a treatment that can provide better effectiveness for their problem,” he says. “The System is beneficial both in terms of just expanding our natural patient base and ultimately adding another way for other practitioners to refer patients to us.” OM