Point of Care Test of LTA Level in Tear Fluid, Measured With a POCT Test, in DE Patients Following IPL Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- LTA
研究概览
简要总结
To quantify and compare tear levels of Intense pulsed light (IPL) and traditional dry eye clinical tests in dry eye patients before and after Intense pulsed light (IPL) treatment.
详细描述
Dry eye is multifactorial, mainly manifested as eye pain, visual impairment (blurred and blurry vision), tear film instability, and tear film hypertonicity, which can cause ocular surface damage. Some possible causes of DED include aging, menopause, Meibomian gland dysfunction (Meibomian gland dysfunction; MGD), Sjogren's syndrome, conjunctival fibrotic disease, refractive surgery, and systemic or topical drugs. Insufficient tear secretion or excessive tear evaporation has been demonstrated to cause precorneal tear concentration or hypertonicity, which disrupts tear film homeostasis. Tear film hypertonicity can cause cell morphological changes, inflammatory cascades, cell death, tear film instability, and further lead to tear hypertonicity. Mgd-induced Evaporative dry eye; EDE) is the most common form of dry eye]. Anti-inflammatory drugs, antibiotics, hot compress, eyelid cleaning and meibomian gland expression are the treatment standards for MGD. However, its long-term efficacy is not satisfactory due to poor patient compliance.
MGD has been found to be associated with eyelid inflammatory disorders. Rosacea affects 5.46% of adults (range 0.09-24.1%) of whom 58% have MGD. Ocular symptoms precede cutaneous rosacea in 15 to 10% of cases, indicating the presence of subclinical variation.
Intense pulsed light (IPL) has mostly been utilized as a dermatological treatment for conditions like facial rosacea, facial erythema, acne, and seborrheic keratosis throughout the last few decades. In 2015, researchers reported the use of IPL for treating MGD to improve the signs and symptoms of DED. Two years later, the TFOS DEWS II report listed IPL as an option for treating DED. Mechanisms of IPL action include liquefication of meibum, regulate inflammation, destroy abnormal blood vessels, inhibit metalloproteinases, and photo modulation. Past studies have reported that IPL treatment modulates tear inflammatory cytokines, with improvements in tear inflammation prior to changes in dry eye signs, however, these studies have been limited by laboratory tests. It is difficult to apply in clinical practice.
Lymphotoxin-alpha (LTA) is a member of the tumor necrosis factor (TNF) superfamily and is expressed by a variety of cells, including T cells, B cells and natural killer cells. LTA secreted to the extracellular space assembles into a homotrimer (LTα3) as a soluble protein, and binds to the tumor necrosis factor receptor to play a role. LTA has been shown to be a diagnostic biomarker for dry eye in past studies. The aim of this study is to investigate the therapeutic mechanism of IPL and provide evidence for the treatment of dry eye by using a point-of-care LTA detection reagent to quantitatively compare the tear LTA levels before and after IPL treatment with traditional dry eye clinical parameters.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •Fitzpatrick skin types I to IV
- •capable and willing to comply with the treatment and follow-up obligations
- •a determination of DED based on (a) the Ocular Surface Disease Index (OSDI) ≥13 score represents severe DED, (b) non-invasive tear film breakup time (NITBUT) of ≤5 sec, or conjunctivocorneal staining score (CS) ≥3 points according to the Japanese Dry Eye Consensus
排除标准
- •Existing ocular trauma, infectious diseases, recent surgical history
- •Skin defects, pigmentation, moles, scars in the treatment area, skin cancer
- •Autoimmune diseases, skin allergies.
- •Pregnancy or lactation
- •Fitzpatrick skin type V or VI.
研究组 & 干预措施
IPL
Participants in the group with 3 sessions of IPL, 2 weeks apart.
干预措施: M22 (Device)
control
Participants in the group with 2 sessions of IPL, 1 session of sham IPL, 2 weeks apart.
干预措施: M22 (Device)
control
Participants in the group with 2 sessions of IPL, 1 session of sham IPL, 2 weeks apart.
干预措施: sham M22 (Device)
结局指标
主要结局
LTA
时间窗: Day-0 (baseline), day-21, day-42, day-63 and day-84
Lymphotoxin-alpha (LTA) is a member of the tumor necrosisfactor (TNF) superfamily and is expressed by a variety of cells, including T cells, B cells and natural killer cells. LTA secreted to the extracellular space assembles into a homotrimer (LTα3) as a soluble protein \[23\], and binds to the tumor necrosis factor receptor to play a role. LTA will be measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of LTA in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized.
Non-invasive tear break-up time (NITBUT)
时间窗: Day-0 (baseline), day-21, day-42, day-63 and day-84
Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
次要结局
- Fluorescein and lissamine conjunctival and cornea staining (CFS)(Day-0 (baseline), day-21, day-42, day-63 and day-84)
- Conjunctival hyperemia (RS score)(Day-0 (baseline), day-21, day-42, day-63 and day-84)
- Meibomian quality(Day-0 (baseline), day-21, day-42, day-63 and day-84)
- Tear Film Lipid Layer Score(TFLL)(Day-0 (baseline), day-21, day-42, day-63 and day-84)
- Tear meniscus height (TMH)(Day-0 (baseline), day-21, day-42, day-63 and day-84)
- Ocular Surface Disease Index (OSDI)(Day-0 (baseline), day-21, day-42, day-63 and day-84)