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): A Factorial Randomized Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Mean of Demodex Count in 30 days after treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Age >18 years.
- •Patients who can understand and follow the study instructions and can adhere to the scheduled follow-up plan.
排除标准
- •Patients who received previous treatment IPL or LLLT
- •Poor compliance with eyelid scrubbing using tea tree oil (TTO)
- •Dead demodex mite on lash.
- •Contraindication of IPL: Skin Fitzpatrick scale V/VI, patients with pigmented lesions on the treatment area (Eyelid, Cheek).
- •Pregnancy or breastfeeding.
- •Active Skin disease: facial skin cancer, graft-versus-host disease, systemic lupus erythaematosus
- •Active eye infection: recurrent herpes simplex
- •Other lid disease ocular trauma, ocular deformity scar, exophthalmos, eyelid insufficiency
- •Patients with pigmented lesion on area of treatment.
研究组 & 干预措施
ShamLLLT plus ShamIPL
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.
干预措施: Mechanical with pharmacological treatment (Procedure)
ShamLLLT plus ShamIPL
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.
干预措施: ShamIPL (Device)
ShamLLLT plus ShamIPL
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.
干预措施: ShamLLLT (Device)
LLLT plus ShamIPL
LLLT : The blue MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) (Thai FDA No 66-2-2-2-0012685)
- No eye shields
- Applying a 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 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.
干预措施: The blue MY MASK-E (Device)
LLLT plus ShamIPL
LLLT : The blue MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) (Thai FDA No 66-2-2-2-0012685)
- No eye shields
- Applying a 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 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.
干预措施: Mechanical with pharmacological treatment (Procedure)
LLLT plus ShamIPL
LLLT : The blue MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) (Thai FDA No 66-2-2-2-0012685)
- No eye shields
- Applying a 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 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.
干预措施: ShamIPL (Device)
IPL plus ShamLLLT
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.
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.
干预措施: ShamLLLT (Device)
IPL plus ShamLLLT
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.
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.
干预措施: IPL (Device)
IPL plus ShamLLLT
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.
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.
干预措施: Mechanical with pharmacological treatment (Procedure)
LLLT plus 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.
LLLT : The blue MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) (Thai FDA No 66-2-2-2-0012685)
- No eye shields
- Applying a 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 days 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.
干预措施: The blue MY MASK-E (Device)
LLLT plus 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.
LLLT : The blue MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) (Thai FDA No 66-2-2-2-0012685)
- No eye shields
- Applying a 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 days 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.
干预措施: IPL (Device)
LLLT plus 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.
LLLT : The blue MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) (Thai FDA No 66-2-2-2-0012685)
- No eye shields
- Applying a 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 days 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.
干预措施: Mechanical with pharmacological treatment (Procedure)
结局指标
主要结局
Mean of Demodex Count in 30 days after treatment
时间窗: 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)
次要结局
- Mean of Demodex Count in 90 days after treatment(90 days after end of treatment. (16th week))
- MGD staging (Severity)(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)