Evaluation of Thermal Pulsation System Treatment for Meibomian Gland Dysfunction in Cataract Surgery Patients
To evaluate the feasibility of promoting post-cataract surgical meibomian gland function and ocular comfort in patients with meibomian gland dysfunction (MGD) by providing a single, in-office thermal pulsation treatment (LipiFlow System), which applies simultaneous heat and pressure to the eyelids, prior to cataract surgery.
This prospective, multicenter, open-label, randomized clinical trial compared 16 subjects (32 eyes), who received a single 12-minute thermal pulsation treatment prior to cataract surgery to 15 untreated matched control subjects (30 eyes). Eligible subjects had MGD with a meibomian gland (MG) secretion score of 0-15 and none to moderate dry eye symptoms with a questionnaire score of 0-15. Outcomes of MG secretion and questionnaire scores were compared between treated and untreated groups at baseline and 1 month and 3 months after cataract surgery on both eyes. Untreated subjects received crossover treatment at 3 months and were followed at 4 months.
Treated group had significantly greater improvement in MG secretion score than control group from baseline to 1 month (p=0.0011) and 3 months (p=0.0002) after surgery. Mean MG scores for treated and control groups, respectively, were: 8.3 ± 3.3 and 8.4 ± 2.7 (Baseline); 21.1 ± 7.8 and 12.7 ± 9.3 (1 Month); and 20.9 ± 9.8 and 11.6 ± 5.1 (3 Months). Control group MG score improved after crossover treatment to 19.2 ± 11.4 at 4 Months. Although baseline mean dry eye symptoms were mild, symptoms at 3 months were reduced in treated group and increased in control group (p=0.0242).
Thermal pulsation treatment of MGD prior to cataract surgery promoted post-surgical meibomian gland function and ocular comfort. Crossover treatment of untreated control group after cataract surgery demonstrated similar improvement in outcomes. These findings support the value of a larger study of thermal pulsation treatment of MGD in cataract surgery patients.