Comparison of Non-pharmaceutical Treatments for Evaporative Dry Eye: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 主要终点
- Non-invasive tear breakup time (NITBUT)
研究概览
简要总结
The lipid layer of the tear film is critical to maintaining the integrity of the tear film and deficiency in the tear film lipid layer (TFLL) is the cause of evaporative dry eye (EDE) in approximately 80% of dry eye disease patients, resulting in excessive evaporation (so-called hyperevaporative dry eye). This study protocol was designed to assess and compare the effects of intense pulsed light (IPL), heated eye mask (HEM), vectored thermal pulsation system (VTPS), and eyelid massage device (EMD) for improving signs and symptoms of EDE.
EDE patients will be randomly divided into IPL, HEM, VTPS, and EMD groups and will be followed up for four weeks. The primary outcome measure will be non-invasive tear breakup time (NITBUT). The secondary outcome measures will include, tear film lipid layer score (TFLL), meibomian gland function and secretion quality change from baseline conjunctival and cornea staining (CFS) with fluorescein and lissamine, tear meniscus height (TMH), conjunctival hyperemia (RS score) and ocular surface disease index (OSDI) questionnaire. Additionally, adverse events also were monitored and documented.
详细描述
"A chronic, diffuse abnormality of the meibomian glands, frequently characterized by terminal duct obstruction and/or qualitative/quantitative abnormalities in glandular secretion," is how the International Workshop on meibomian gland (MG) hypofunction or dysfunction (MGD) describes MGD. These glands, which are repurposed sebaceous glands, secrete meibum onto the ocular surface. By improving the quality and quantity of meibum secretion, signs and symptoms of evaporative dry eye (EDE) and MGD can be alleviated.
Traditional remedies derived from natural sources have been utilized for treating anterior eye ailments since ancient times, predating the advent of contemporary pharmacological interventions. These remedies continue to be employed in diverse populations globally. The objective of this study is to examine the present non-pharmacological modalities that have been implemented and evaluate their efficacy. This encompasses alternative medicine, extant non-pharmaceutical therapeutic modalities, as well as contemporary low and high technological interventions. The most common approaches to relieving MGD involve the application of heat to the eyelids with and without physical massage of the eyelids in order to express the MGs.
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 (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
- •Able and willing to comply with the treatment/follow-up schedule
- •Bilateral signs and symptoms of dry eye disease (a) the ocular surface disease index (OSDI) questionnaire ≥ 13, (b) a non-invasive tear film breakup time (NITBUT) of ≤10 s, or a conjunctivocorneal staining score (CS) of ≥ 3 points. The presence of two or more criteria was used to establish a positive DE diagnosis, based on the 2016 Asia Dry Eye Society criteria
- •Lipid layer thickness score evaluation ≥ 2.
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
- •photophobia that may cause reflex tearing or difficulty in evaluating the patient's lipid layer.
研究组 & 干预措施
Group A: IPL group
participants will receive IPL treatment with 12 homogeneously spaced pulses of light to both eyes at day 0, day 14, and day 28
干预措施: IPL (Device)
Group B: HEM group
participants were applied an air-activated disposable eye mask on both closed eyes (Ocuface Medical Co., Ltd., Guangzhou, China) simultaneously for 15 minutes according to the manufacturer's instructions every day for 42 days
干预措施: Heated eye mask (Device)
Group C: VTPS group
VTPS group, Patients will receive a single 12-minute treatment using the LipiFlow® (TearScience Inc., Morrisville, NC) on both eyes at day 0
干预措施: LipiFlow® (Device)
Group D: EyePeace® group
Participants were followed immediately by 10 gentle squeezes of the eyelid massage device (EMD) on both eyes, and 10 gentle eyelid massaging movements using the index and middle fingers every day for 42 days.
干预措施: EyePeace® (Device)
结局指标
主要结局
Non-invasive tear breakup time (NITBUT)
时间窗: • Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.
Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequential 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
- Ocular Surface Disease Index (OSDI)(• Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.)
- Fluorescein and lissamine conjunctival and cornea staining (CFS)(• Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.)
- Tear meniscus height (TMH)(• Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.)
- Tear Film Lipid Layer Score (TFLL)(• Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.)
- Meibomian gland function and secretion quality(• Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.)
- Conjunctival hyperemia (RS score)(• Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.)
- Thermal imaging: Ocular surface temperature (OST)(• Changes at day-14, day-28 and day-42will be compare with baseline measurements. • Comparison between groups at baseline, day-14, day-28 and day-42will also be examined.)