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Completed
NCT07169461
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)
Conditions: Demodex Blepharitis, Meibomian Gland Dysfunction (MGD)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 88
Sponsor: Chulalongkorn University
Location: Chulalongkorn University Pathum Wan Bangkok
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07169461). StuddyBuddy aggregates publicly available trial information.