Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress Therapies for MGD- An RCT
Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
Meibomian gland dysfunction (MGD), closely associated with Dry Eye Disease (DED), is a
chronic condition where terminal ducts are obstructed and/or glandular secretion changes. The
efficacy of traditional treatment options, e.g. eyelid warm compress therapy (EW) is limited
with low compliance. This study aims to (1)compare the efficacy and safety of two emerging
alternatives- vectored thermal pulsation(VTP) or intense pulsed light and meibomian gland
expression(IPL + MGX) with EW therapy; (2)identify factors predicting outcome.
This is a prospective, randomized, assessor-masked, active-controlled clinical study. 360
participants (360 study eyes) with mild-to-moderate MGD will be randomized by minimization
into three arms equally, receiving either VTP by TearScience-LipiFlow® Thermal Pulsation
System (month 0), IPL by Lumenis®️M22 with MGX (month 0, 1, 2, 3) or EW (twice daily).
Lubricating eye drops (3% Hypromellose) will be provided for all subjects throughout the
study period(15 months). Tear film breakup time will be assessed as primary outcome at month
6, 15. Serial measurements of MG, tear-film, DED-related parameters, intraocular pressure,
compliance to EW, factors associated with outcomes and treatment-related complications will
be conducted at baseline and each follow-up visit by masked observers at baseline and eight
follow-up evaluation (month 0, 1, 2, 3, 4, 6, 9, 12, 15).