Vectored Thermal Pulsation, Intense Pulsed Light, and Eyelid Warm Compress Therapies for MGD

NAActive, not recruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

October 8, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Meibomian Gland Dysfunction
Interventions
DEVICE

Vectored thermal pulsation (VTP) therapy

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).

DEVICE

Intense pulsed light with meibomian gland expression (IPL+MGX) therapy

"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)."

BEHAVIORAL

Eyelid Warm Compress Therapy (EW)

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.

DRUG

Topical eye drops (Hypromellose, 3mg/ml)

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).

Trial Locations (4)

Unknown

Hong Kong Eye Hospital, Kowloon

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The Chinese University of Hong Kong Eye Centre (CUHKEC), Kowloon

Prince of Wales Hospital, Shatin

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The CUHK Medical Centre (CUHKMC), Shatin

All Listed Sponsors
lead

Chinese University of Hong Kong

OTHER