MAY 25, 2012
This randomized study compared the safety and effectiveness of the LipiFlow System (TearScience, Morrisville, N.C.) with the iHeat Warm Compress System (Advanced Vision Research, Woburn, Mass.) in adults with meibomian gland dysfunction (MGD). The LipiFlow was significantly more effective.
LipiFlow is designed to safely heat the palpebral surfaces of the upper and lower eyelids while simultaneously applying graded pulsatile pressure to the outer eyelid surfaces. The device, which is administered during an office visit, massages the outer eyelids from the base of the meibomian glands in the direction of the gland orifices.
The study randomized 139 subjects (278 eyes) with dry eye symptoms and evidence of meibomian gland obstruction to treatment with LipiFlow or iHeat. The LipiFlow group was followed for four weeks after treatment. iHeat subjects were instructed to undergo treatment at home for five minutes daily for two weeks. Afterward, they crossed over and underwent LipiFlow treatment.
LipiFlow treatment resulted in significant improvement (P < 0.05) in meibomian gland secretion at two and four weeks (mean ± standard deviation at baseline = 6.3 ± 3.5; 2 weeks = 14.3 ± 8.7; 4 weeks = 16.7 ± 8.7) and tear break-up time (TBUT) at two and four weeks (at baseline = 5.5 ± 2.9; 2 weeks = 6.9 ± 5.0; 4 weeks = 7.4 ± 5.5). However, these measures did not significantly change in the iHeat group.
Both groups experienced a statistically significant decrease in dry eye symptom frequency and severity, although this improvement was significantly greater in subjects treated with LipiFlow. The incidence of nonserious, device-related adverse events was not significantly different between the groups.
The authors say the trend toward further improvement in signs and symptoms at the four-week visit in patients treated with LipiFlow offers a positive prognosis for future studies evaluating this therapy over a longer duration. They speculate that this continued improvement may be due to the restoration of function of previously blocked meibomian glands and hypothesize that the increase in gland function improves tear film stability.