Effectiveness of Low Level Light Therapy and Intense Pulse Light on Mite Count as Adjuntive Therapies in Demodex Blepharitis Using Artificial Intelligent Program (Ai-Demodex)

NAEnrolling by invitationINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

January 16, 2025

Primary Completion Date

September 15, 2025

Study Completion Date

December 30, 2025

Conditions
Demodex BlepharitisMeibomian Gland Dysfunction (MGD)
Interventions
DEVICE

The blue MY MASK-E

"Device-Specific Protocol Blue MyMask® LLLT (Espansione): Emits monochromatic photobiomodulation therapy at 633 nm, distinct from conventional red or near-infrared LLLT used in other studies.~Espansione IPL: Uses a patented Optimal Power Energy (OPE®) system with a polychromatic spectrum of 590-1200 nm, allowing sub-threshold energy pulses for selective thermal effects on abnormal telangiectasia and Demodex-related inflammation."

DEVICE

IPL

"IPL : The Eye-light device (Espansione Marketing S.p.A., Bologna, Italy,waveleggths 1,200-1,500 nm, Delivery system 12cm2) (Thai FDA No 66-2-2-2-0012685) :~* Protective eye shields~* 5 flashes of light were applied for each eye (3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim)~* Therapeutic energy level (10-16 joules/ cm2) based on the degree of skin pigmentation."

PROCEDURE

Mechanical with pharmacological treatment

"Mechanical with pharmacological treatment : Warm compression 15 minutes + Lid hygiene + 1% TTO 2 times per day for 90 days~1%TTO : OCuSOFT Oust Demodex Eyelid Cleanser Foam Bottle 50ml (OCuSOFT, Richmond, TX) is the only commercially available medication in Thailand that contains 1% tea tree oil."

DEVICE

ShamIPL

the Eye-light device (Espansione Marketing S.p.A., Bologna, Italy) - Protective eye shields, 5 time for each eye with flashes of light off , but flashes sound on.

DEVICE

ShamLLLT

the MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) - No eye shields, applying a power off special mask for 15 minutes but light on , once a week for 4 weeks

Trial Locations (1)

10330

Chulalongkorn University, Pathum Wan

All Listed Sponsors
lead

Chulalongkorn University

OTHER