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)

Not Applicable

• Conditions: Demodex Blepharitis; Meibomian Gland Dysfunction (MGD)

• Registration Number: NCT07169461
• Lead Sponsor: Chulalongkorn University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-16
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Primary Completion: 2025-09-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. All patients who received a definite diagnosis of demodex blepharitis based on cylindrical dandruff at the base of the lashes and the presence of at least one alive demodex mites on eyelid margin by microscopy
2. Age >18 years.
3. Patients who can understand and follow the study instructions and can adhere to the scheduled follow-up plan.

Exclusion Criteria

1. Patients who received previous treatment IPL or LLLT
2. Poor compliance with eyelid scrubbing using tea tree oil (TTO)
3. Dead demodex mite on lash.
4. Contraindication of IPL: Skin Fitzpatrick scale V/VI, patients with pigmented lesions on the treatment area (Eyelid, Cheek).
5. Pregnancy or breastfeeding.
6. Active Skin disease: facial skin cancer, graft-versus-host disease, systemic lupus erythaematosus
7. Active eye infection: recurrent herpes simplex
8. Other lid disease ocular trauma, ocular deformity scar, exophthalmos, eyelid insufficiency
9. Patients with pigmented lesion on area of treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Mean of Demodex Count in 30 days after treatment	30 days after end of treatment. (8th week)	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)

Secondary Outcome Measures

Name	Time	Method
Mean of Demodex Count in 90 days after treatment	90 days after end of treatment. (16th week)	Mean of Demodex Count in 90 days after treatment per right eye in 90 days after end of treatment.(16th week)
MGD staging (Severity)	Day 0, 8th week,16th week	OSDI questionnaire used to evaluate ocular dry eye symptoms. Meibum Quality. Meibum Expressibility. Telangiectasia grading: 0-3
Surface Staining: NEI Grading System.	Day 0 , 8th week ,16th week
Lipid Layer Thickness by LIPIVIEW	Day 0 , 8th week , 16th week
Noninvasive break-up time (NIBUT)	Day 0, 8th week,16th week
Tear meniscus height (TMH)	Day 0 , 8th week ,16th week
% Meibomian Gland Loss (MGL)	Day 0 , 8th week ,16th week

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Pathum Wan, Bangkok, Thailand