Thermal pulsation device clears gland blockages

April 1, 2012

The FDA clearance this past February for a second-generation version of a proprietary device allows physicians to treat both eyes simultaneously for meibomian gland dysfunction and evaporative dry eye in a relatively painless in-office procedure.

The new version gives physicians greater flexibility to adjust the pressure and displays the treatment temperature, pressure sequence, and treatment time remaining. Tim Willis, chief executive officer of TearScience, noted that 12 million to 13 million U.S. patients suffer from moderate to severe dry eye, and more than 80% of them could be helped with the system.

"All the other treatments before us have been around the use of eye drops," he said, "where we're actually treating the cause of evaporative dry eye by opening these glands, removing the obstruction, cleaning them out, and putting the eyelids back to the natural situation of producing lipids for the eye."

"Once they're cleaned out, the . . . body will regulate those glands and they'll start working," Willis said.

The entire procedure takes 12 to 15 minutes, and patients can drive home. Most patients notice the difference within 2 weeks, but the effect could take 4 to 6 weeks for those patients whose ocular surfaces were especially irritated by prolonged, severe dry eye. The effect lasts an average of 9 to 15 months, and perhaps as long as 32 months for some patients.

"It really depends on the patients," Willis said. "It depends on their environment and what type of work they do."

Frequent use of computers and similar devices puts patients at risk because they blink less often, he noted.

Replaces manual expression

The device replaces manual expression of the glands or warm compresses patients used up to twice daily at home. Willis said that manual expression is very painful for patients.

"Think of taking your eyelid, putting it between two thumbs, and mashing really hard," he said. By contrast, the TearScience procedure is "spa-like," Willis said.

The treatment may not eliminate the use of drops, but it might make them less necessary and more effective, he said.

In a study of 139 patients in a randomized, controlled, multicenter clinical trial, patients treated with the system had a statistically significant greater improvement in the average number of glands yielding clear liquid at 2 weeks compared with control patients treated with a daily warm compress.

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