Primary Objective: To evaluate the efficacy of LLLT, IPL, and IPL + LLLT in re ducing demodex count in patients with Demodex Blepharitis. Secondary Objectives: To evaluate the efficacy of LLLT, IPL, and IPL + LLLT in improving ocular surface parameters in Demodex Blepharitis. Sample Size: 88 participant ( 22 participants per group x 4 groups) Study Design: 2x2 Factorial randomized trial. Methodology: The study is composed of 4 groups including 1) control 2) Blue light LLT alone 3) IPL alon e, 4) Blue light LLLT with IPL , and . Both LLLT and IPL will treat weekly for 4 sessions All participants will be instructed to perform warm compression and lid scrub. The outcomes include demodex count, meibum grading and ocular surface parameter were evaluated at 1 and 3 months post treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
88
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.
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.
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.
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.
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
Chulalongkorn University
Pathum Wan, Bangkok, Thailand
Mean of Demodex Count in 30 days after treatment
The number of Demodex mites per eyelash on a total of 4 collarettes lashes epilation (2 from upper eyelid ,2 from lower eyelid and identification by anatomical imaginary line of nasal and temporal limbus) per right eye in 30 days after end of treatment. (8th week)
Time frame: 30 days after end of treatment. (8th week)
Mean of Demodex Count in 90 days after treatment
Mean of Demodex Count in 90 days after treatment per right eye in 90 days after end of treatment.(16th week)
Time frame: 90 days after end of treatment. (16th week)
MGD staging (Severity)
OSDI questionnaire used to evaluate ocular dry eye symptoms. Meibum Quality. Meibum Expressibility. Telangiectasia grading: 0-3
Time frame: Day 0, 8th week,16th week
Surface Staining: NEI Grading System.
Time frame: Day 0 , 8th week ,16th week
Lipid Layer Thickness by LIPIVIEW
Time frame: Day 0 , 8th week , 16th week
Noninvasive break-up time (NIBUT)
Time frame: Day 0, 8th week,16th week
Tear meniscus height (TMH)
Time frame: Day 0 , 8th week ,16th week
% Meibomian Gland Loss (MGL)
Time frame: Day 0 , 8th week ,16th week
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