Long-Term Effectiveness of Single Thermal Pulsation Treatment for Meibomian Gland Dysfunction and Evaporative Dry Eye
To evaluate the long-term (up to 1 year) effectiveness in improving meibomian gland function and dry eye symptoms after a single, in-office, 12-minute thermal pulsation treatment (LipiFlow System), which applies simultaneous heat and pressure to the eyelids for treatment of meibomian gland dysfunction (MGD).
This prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) with MGD and dry eye symptoms, who were randomized to a single thermal pulsation treatment (Treatment group) or twice daily conventional therapy for 3 months (Control group). Control group subjects received crossover thermal pulsation treatment at 3 Months (Crossover group). Outcome measures of MG secretion and dry eye symptom scores were evaluated at baseline and 3, 6, 9 and 12 Months. Subjects with inadequate symptom relief could receive additional MGD therapy after 3 months in the Treatment group and after 6 months in the Crossover group.
At 12 months, 86% of Treatment group subjects had only one thermal pulsation treatment and no other MGD or dry eye therapy with a sustained mean improvement from baseline in MG secretion (6.4 ± 3.7 to 17.3 ± 9.1; p<0.0001) and dry eye symptoms (44.1 ± 20.4 to 21.6 ± 21.3; p<0.0001). Furthermore, 89% of Crossover group subjects had only one thermal pulsation treatment at 12 Months with a sustained mean improvement from baseline in MG secretion (6.3 ± 3.6 to 18.4 ± 11.1; p<0.0001) and dry eye symptoms (49.1 ± 21.0 to 24.0 ± 23.2; p<0.0001).
A single thermal pulsation treatment provides sustained effectiveness over one year, as shown by mean improvement in meibomian gland function and mean reduction in dry eye symptoms from baseline. These results also reflect that most patients do not need additional therapy for inadequate symptom relief after thermal pulsation treatment.