A new system, the LipiFlow, for the treatment of meibomian gland dysfunction.
OBJECTIVE
To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress (WC) for adults with meibomian gland dysfunction (MGD).


METHODS
This was a non-significant risk, prospective, open-label, randomized, crossover multicenter clinical trial. One hundred thirty-nine subjects were randomized between LipiFlow (n=69) and WC control (n=70). Subjects in the LipiFlow group received a 12-minute LipiFlow treatment and were reexamined at 1 day, 2 weeks and 4 weeks. Control subjects received a 5-minute iHeat treatment with instructions to perform the same treatment daily for 2 weeks. At 2 weeks, they crossed over (LipiFlow Crossover) and received the LipiFlow treatment. Effectiveness parameters: meibomian gland (MG) assessment, tear break-up time (TBUT) and dry eye symptoms. Safety parameters: adverse events, ocular health exam, ocular surface staining, intraocular pressure, visual acuity and discomfort.


RESULTS
LipiFlow resulted in significant improvement (P < 0.05) in MG secretion at 2 and 4 weeks (mean ± standard deviation at baseline = 6.3 ± 3.5; 2 weeks = 14.3 ± 8.7; 4 weeks = 16.7 ± 8.7); and TBUT at 2 and 4 weeks: (at baseline = 5.5 ± 2.9; 2 weeks = 6.9 ± 5.0; 4 weeks = 7.4 ± 5.5). There was no significant change in MG secretion or TBUT in the control group. LipiFlow resulted in a greater significant reduction in dry eye symptoms than the iHeat WC. The crossover group demonstrated similar significant improvement 2 weeks post-treatment with the LipiFlow. There was no significant difference between groups in the incidence of non-serious, device-related adverse events.


CONCLUSIONS
The LipiFlow System was significantly more effective than iHeat WC. These results support its safety and effectiveness in the treatment of MGD and dry eye symptoms.
Associated Eye Care, Stillwater, MN, USA.
Stephen S
SS
Lane
Harvey B
HB
DuBiner
Randy J
RJ
Epstein
Paul H
PH
Ernest
Jack V
JV
Greiner
David R
DR
Hardten
Edward J
EJ
Holland
Michael A
MA
Lemp
James E
JE
McDonald
David I
DI
Silbert
Caroline A
CA
Blackie
Christy A
CA
Stevens
Raman
R
Bedi
D000293:Adolescent; D000328:Adult; D001831:Body Temperature; D018592:Cross-Over Studies; D015352:Dry Eye Syndromes / Q000503:physiopathology / Q000628:therapy*; D005141:Eyelid Diseases / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D006979:Hyperthermia, Induced / Q000295:instrumentation*; D007429:Intraocular Pressure / Q000502:physiology; D008537:Meibomian Glands; D009885:Ophthalmology / Q000295:instrumentation*; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology