At a glance
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Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress (VIEW) Therapies for Meibomian Gland Dysfunction- A Randomized, Assessor-masked, Active-controlled Clinical Trial
In Brief
A clinical study evaluating Vectored thermal pulsation (VTP) therapy, Intense pulsed light with meibomian gland expression (IPL+MGX) therapy, and 2 other interventions for Meibomian Gland Dysfunction. Completed, enrolled 374 participants across 4 sites.
Detailed 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).
Study Details
Timeline
Interventions
VTP purchased from TearScience®️ is an automated thermal pulsation system that is designed to heat and simultaneously evacuate the meibomian gland contents. It is performed by the unmasked treating investigators as described by the equipment manufacturer. In brief, one to two drops of topical anesthesia are applied prior to the bilateral application of the activators. The inner portion of the activator applies a constant temperature of 42.5°C to the tarsal conjunctiva of upper and lower eyelids. Simultaneously, the outer portion of the activator applies directional, pulsatile pressure to the external eyelid surfaces (maximum 6 psi) for the 12-minute treatment cycle. Participants will receive one session of VTP treatment only (month 0).
IPL is delivered using the proprietary "dry eye mode" setting of the Lumenis®️ M22TM system per the Toyos protocol. Pulse intensity (11-14 J/cm2) is inversely related to the Fitzpatrick skin phototype of each participant and will be used for the same patient throughout the study. IPL will be delivered to four overlapping zones inferior to each eye and a fifth pulse applied temporally adjacent to the lateral canthus four times. Both eyelids are closed and sealed with IPL-Aid disposable eye shields. MGX is immediately performed on both upper and lower eyelids of each eye and pain will be minimized by topical anesthetic. Participants will receive four-session IPL and MGX treatment (month 0, 1, 2 ,3).
EW using warm wet towel to each eye is performed twice daily for 10 mins. A treatment diary will be given for patients randomized to EW for daily recording which will be reviewed and recorded by the unmasked study coordinator at each study visit.
All patients will be given one single topical lubricant (Hypromellose, 3mg/ml) to be used as frequently as needed from recruitment to study exit (total 16 months).