Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients With Dry Eye Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Two-tailed Paired T-test of Persons with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _OSDI
研究概览
简要总结
Dry eye disease (DED) is a multifactorial ocular surface condition characterized by instability of the tear film. DED is common in ophthalmic and optometric clinical practice, and meibomian gland dysfunction (MGD) has been identified as a major cause of evaporative DED. The use of heated eye mask is a common recommendation in the treatment of MGD, aiming to adequately heat the meibum to increase its liquefaction and flow. Several products are available for this purpose (e.g., Bruder Moist Heat Eye Compress [Bruder Healthcare Company], EyeGiene® [Eyedetec Medical], Blepha EyeBag® [formerly MGDRx EyeBag, Théa Pharmaceuticals Ltd], Blephasteam® [Théa Pharmaceuticals Ltd]).
This study employs far-infrared eye masks on the acupoints around the eyes, including Jingming, Taiyang, Sibai, Tongziliao, and Si Zhu Kong to assess whether there is an improvement in the symptomatic indicators of dry eye disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •*Clinical diagnosis of Dry Eye Disease by Ocular Surface Disease Index (OSDI) ≥ 13 and NIBUT <10 seconds.
排除标准
- •Eye inflammation
- •Eyelid malposition, such as entropion, ectropion, and upper eyelid ptosis
- •Recent eye surgery (within 3 months)
- •Risks of retinal detachment such as high myopia, lattice degeneration, and retinal holes
- •Use anti-inflammatory eye drops (topical steroids or cyclosporine) within 1 month
研究组 & 干预措施
Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients with DED
干预措施: Far Infrared Eye Masks (Device)
结局指标
主要结局
Two-tailed Paired T-test of Persons with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _OSDI
时间窗: 2 years
OSDI is collected in scores All the data mentioned above will be collected before and after treatment one month later. They will be compared with two-tailed paired t-test separately. P \< 0.05 was considered statistically significant.
Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _Meibomian Gland Loss
时间窗: 2 years
Meibomian Gland Loss in percentage will be collected before and after treatment 30 mins and one month later . They will be compared with two-tailed paired t-test separately. P \< 0.05 was considered statistically significant.
Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _NIBUT(non-invasive break-up time)
时间窗: 2 years
NIBUT(non-invasive break-up time) recorded in sec will be collected before and after treatment 30 mins and one month later. They will be compared with two-tailed paired t-test separately. P \< 0.05 was considered statistically significant.
Two-tailed Paired T-test of Eyes with Dry Eye Diseases with Far Infrared Mask Treatment Assessed by _Schirmer test
时间窗: 2 years
Description: Schirmer test in mm. All the data mentioned above will be collected before and after treatment 30 mins and one month later. They will be compared with two-tailed paired t-test separately. P \< 0.05 was considered statistically significant.
次要结局
未报告次要终点