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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ShamLLLT plus ShamIPL | Sham Comparator | ShamLLLT : the MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) - No eye shields, applying a power off special mask for 15 minutes , once a week for 4 weeks 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. with Mechanical with pharmacological treatment : Warm compression 15 minutes + Lid hygiene + 1% TTO 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. |
|
| LLLT plus ShamIPL | Experimental | LLLT : The blue MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) (Thai FDA No 66-2-2-2-0012685)
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. with 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. |
|
| IPL plus ShamLLLT | Experimental | 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) :
ShamLLLT : the MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) - No eye shields, applying a power off special mask for 15 minutes , once a week for 4 weeks with 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The blue MY MASK-E | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 days after end of treatment. (8th week) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 90 days after end of treatment. (16th week) |
| MGD staging (Severity) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vannarut Satitpitakul, MD | Department of ophthalmology, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn University | Pathum Wan | Bangkok | 10330 | Thailand |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2024 |
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|
| LLLT plus IPL | Experimental | 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) :
LLLT : The blue MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) (Thai FDA No 66-2-2-2-0012685)
|
|
|
| IPL | Device | 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) :
|
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| Mechanical with pharmacological treatment | Procedure | 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. |
|
| ShamIPL | Device | 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. |
|
| ShamLLLT | Device | 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 |
|
OSDI questionnaire used to evaluate ocular dry eye symptoms. Meibum Quality. Meibum Expressibility. Telangiectasia grading: 0-3
| Day 0, 8th week,16th week |
| 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 |
| Mar 4, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 1, 2024 | Mar 4, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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