Evaluation of the Effects and Safety by the Steam Eye Mask With Acupoints Stimulation for VDT User
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Assessment of symptoms and mood state (Visual Analog Scale, VAS) evaluated by participants.
研究概览
简要总结
To evaluate the effects and safety of the steam eye mask with acupoints stimulation by the moist heat of approximately 40 degree C for 20 minutes and massage acupoints on eyebrows for eye fatigue, dry eye symptoms and symptom-induced decline of Quality of life (QoL) in VDT users.
详细描述
A prospective study is conducted to evaluate the effect of the steam eye mask with acupoints stimulation on eye fatigue and dry eye symptoms in VDT users. The effects and safety of the single therapy by the moist heat of approximately 40 degree C for 20 minutes with eyebrows acupoints massage for the first 3 minutes are evaluated in the single application study, and the effects and safety of the repeated therapy by the moist heat applied and massage acupoints on eyebrows once per working day for two weeks are evaluated in the repeated application study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females aged from 20 to 69 years old (both inclusive).
- •Participants who use VDTs, including laptops, electronic tablets, readers and smartphones for 6 hours or more a day.
- •Participants who respond to the 16 symptoms of visual symptoms related to computer use in the working population for the total score over 6 based on a computer vision syndrome questionnaire.
- •Participants who respond to more than 1 of 12 typical dry eye symptoms by "constantly" or "often" based on a dry eye questionnaire.
- •Participants are able and willing to comply with all protocol requirements and procedures.
- •Participants who must be capable of providing informed consent document, with one's signature.
排除标准
- •Participants with eye diseases that could affect the ocular surface (e.g. Ocular inflammation, infectious conjunctivitis, allergic diseases, autoimmune diseases and collagen diseases).
- •Participants who have been treated by physicians because of eye diseases and do not recover from that disease yet at the moment of joining to this study, or participants who need to be treated by physicians because of eye disease.
- •Participants with the excessive meibomian lipid secretion (seborrheic MGD).
- •Participants with trauma, swelling and eczema at the skin around eyes.
- •Participants with allergic reaction for heating, abnormality of the heat or depression of the heat.
- •Participants who are deemed inappropriate to participate in this study by physicians.
结局指标
主要结局
Assessment of symptoms and mood state (Visual Analog Scale, VAS) evaluated by participants.
时间窗: 14 days
The severity of symptoms and mood state are evaluated using a VAS by each participant. A VAS is a horizontal line, 100mm in length, anchored by word descriptors at each end. Participants mark on the line the point that they feel their perception of their current state. The VAS score is determined by measuring the length from the left hand end of the line to the point that they mark. The five symptoms to be evaluated are: tiredness of eyes, dryness of eyes, grittiness of eyes, blurred vision, and ocular discomfort. Each symptom is relieved as the VAS score decreases. The mood states to be evaluated are: relaxation and comfort. Each mood state is enhanced as the VAS score increases.
次要结局
- The quality of life (Dry-Eye-Related Quality of Life Score, DEQS) evaluated by participants.(14 days)
- Measurement of Tear Meniscus Height (TMH) using Oculus Keratograph 5M by an examiner.(14 days)
- Tear film breakup time (TBUT) evaluated by an examiner.(14 days)
- The computer visual syndrome questionnaire (CVS-Q) evaluated by participants.(19 days)
- Dry eye questionnaire evaluated by participants.(19 days)
- Schirmer test evaluated by an examiner.(19 days)
- Meibomian gland expression evaluated by an examiner.(19 days)
- Visual acuity (VA) evaluated by an examiner.(14 days)
- Intraocular pressure (IOP) evaluated by an examiner.(14 days)
- Ocular surface/eyelids findings diagnosed by an examiner.(19 days)
- Diary reported by a participant.(14 days)
- Adverse events(19 days)
- Staining of ocular surface evaluated by an examiner(14 days)