Efficacy of Adjunctive Low-Level Light Therapy to Intense Pulsed Light for Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Lipid layer thickness (LLT)
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) versus intense pulsed light (IPL) alone for the treatment of meibomian gland dysfunction (MGD).
The main question it aims to answer is does the adjunctive of low-level light therapy (LLLT) to intense pulsed light (IPL) provide more beneficial treatment effects than intense pulsed light (IPL) alone in treating meibomian gland dysfunction (MGD) patients?
Participants will be randomized into 2 groups: adjunctive low-level light therapy (LLLT) to intense pulsed light (IPL) group (ALLLT +IPL) and IPL alone group.
详细描述
In both the IPL group and the ALLLT+IPL group, the doctor will administer IPL therapy to each participant and apply the Light Modulation® special facial mask to their faces. The assistant nurse will activate the light power, ensuring that the doctor remains blind to treatment allocation. Participants in both groups will receive a conventional treatment for MGD including warm compression and lid hygiene. Moreover, all participants will be advised to use preservative-free artificial tears 4 times daily throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, 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
- 否
入选标准
- •MGD severity level 2 and above according to the international workshop on MGD
- •Fitzpatrick skin type of 1-4 according to sun sensitivity characteristics and appearance of the skin color
排除标准
- •History of previous ocular trauma or surgery within the past six months
- •Contact lens-wearing patients
- •Patients with skin-pigmented lesions in the treatment area
- •Pregnancy or breastfeeding patients
- •Patients with any uncontrolled ocular or systemic diseases
研究组 & 干预措施
ALLLT + IPL group
Participants will receive a session of IPL therapy followed by LLLT therapy, once weekly for 4 weeks (total 4 treatment sessions). The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim. The LLLT therapy will be delivered using the Light Modulation® special facial mask (Espansione Marketing S.p.A., Bologna, Italy) which will be placed on the participant's face for 15 minutes. The mask has the shape of a half-face and will emit a red light in a light-emitting diode (LED) system.
干预措施: Low-level light therapy (LLLT) (Device)
ALLLT + IPL group
Participants will receive a session of IPL therapy followed by LLLT therapy, once weekly for 4 weeks (total 4 treatment sessions). The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim. The LLLT therapy will be delivered using the Light Modulation® special facial mask (Espansione Marketing S.p.A., Bologna, Italy) which will be placed on the participant's face for 15 minutes. The mask has the shape of a half-face and will emit a red light in a light-emitting diode (LED) system.
干预措施: Intense pulsed light (IPL) (Device)
IPL alone group
The IPL alone group will receive only a session of IPL therapy, once weekly for 4 weeks (total 4 treatment sessions). The IPL therapy will be performed using the Eye-light® with Optimal Power Energy® (Espansione Marketing S.p.A., Bologna, Italy), which emits the light at a wavelength of 600 nm IPL system with fluence ranging from 10 to 16 J/cm2 per eye depending on the Fitzpatrick skin scale. During IPL treatment 5 flashes of light will be applied to the skin around the eye using a handheld device; 3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim, similar to the combined group. Additionally, the special facial mask will also be placed on the participant's face for 15 minutes with no light power applied.
干预措施: Intense pulsed light (IPL) (Device)
结局指标
主要结局
Lipid layer thickness (LLT)
时间窗: baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment
Lipid layer thickness will be evaluated using Lipiview® II interferometer (TearScience®, Johnson \& Johnson Vision, California, USA). The thickness of the lipid layer is then calculated from the interference pattern and expressed in interferometric color units (ICU), where 1 ICU reflects approximately 1 nm of lipid layer thickness.
次要结局
- Meibum quality score(baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment)
- Tear film break-up time (TBUT)(baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment)
- Meibum expressibility score(baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment)
- Meiboscore(baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment)
- Conjunctival and corneal staining:(baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment)
- Ocular surface disease index (OSDI) scores(baseline, 2 weeks, 4 weeks, 12 weeks, and 24 weeks post treatment)
- Tear cytokines levels(baseline and 12 weeks post treatment)