Abstract
BACKGROUND: Meibomian gland dysfunction (MGD) is one of the most prevalent chronic eye diseases, characterized by meibomian gland obstruction and abnormal meibum secretion both in quantity and quality. OBJECTIVE: To assess the efficacy and safety of vectored thermal pulsation (VTP), intense pulsed light plus meibomian gland expression (IPL + MGX), and eyelid warm compress (EW). METHODS: This is a 3-arm, assessor-masked, randomized controlled trial. 360 symptomatic mild to moderate MGD subjects would be recruited and randomized into 3 intervention groups. Subjects from Group-A, Group-B, and Group-C would be treated with one-session VTP (at baseline), four-session IPL + MGX (at baseline, month-1, month-2, and month-3 visits), and twice-daily EW for 15 months, respectively. All subjects would be prescribed topical artificial tears (Hypromellose, 0.3% w/v) to be used as frequently as needed from wash-out (1 month before baseline) to endpoint (month-15 visit). Subjects would be assessed 9 times throughout a total of 16-month study period. Five self-administered questionnaires would be collected each time in random order. Masked observers would conduct examinations using slit-lamp biomicroscopy, LipiView® II, and Keratograph 5M machines. The eye with worse MGD would be selected and analyzed as the study eye. Tear film break-up time (TFBUT) at month-6 and month-15 visits are the primary outcomes. RESULTS: 374 subjects were enrolled and randomized into three groups, and 372 subjects (aged 54.4 ± 14.7 years) were finally analyzed. The mean of TFBUT time at baseline was 3.1 ± 1.7 seconds. CONCLUSION: This is the first head-to-head comparison of three physical treatments for mild to moderate MGD on their therapeutic efficacy, safety, longevity and compliance in a randomized controlled trial setting.