Acupuncture for Dry Eye Syndrome : A Randomized, Patient-Assessor Blinded, Non-acupuncture Point Shallow Penetration-Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Ocular Surface Disease Index : OSDI
研究概览
简要总结
This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham acupuncture controlled study. Additionally, the investigators will assess the safety of acupuncture treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have had dry eye syndromes in single eye or in both eyes e.g. Other disorders of lacrimal gland: Dry eye syndrome (ICD-10: H04.1). He or she must have both of the conditions below:
- •Patients who have had such symptoms like ocular itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing
- •Patient whose tear film break-up time (BUT) is below 10 seconds and measured tear amount is below 10mm/5sec by Schirmer 1 test
排除标准
- •Those who have defects of eyelid or eyelashes
- •Those who have acute infection of eyelid, eyeball or accessories of eye
- •Those who have Stevens-Johnson syndromes or Pemphigoids
- •Those who have Vitamin A deficiency
- •Those who have any defects of eye or accessories of eye by external injuries
- •Those who have undergone any surgical operation for eye during last 3 months
- •Those who are using contact lens
- •Those who have any difficulties about eye opening or eye closing due to facial palsy
- •Those who have undergone punctual occlusion surgery
- •Those who have used any kinds of anti-inflammatory eyedrops for recent 2 weeks (steroids, cyclosporin or autologous serum eyedrops)
- •Those who have systemic immune therapy
- •Those who are pregnant or have any plan for pregnancy
- •Those who are not appropriate to this study by investigators decision
结局指标
主要结局
Ocular Surface Disease Index : OSDI
时间窗: Visit 11 (after 3 weeks from baseline)
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores will be calculated according to the following formula: OSDI = \[(sum of scores for all questions answered)\*100\] / \[(total number of questions answered)\*4\]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline.
次要结局
- Visual Analogue Scale of Self Symptoms(every visit)
- Schirmer 1 Test(visit 1,10)
- Tear Film Break-up Time : BUT(Visit 1, 10)
- Medication Quantification Scale (MQS)(every visit)
- General Assessment(visit 11)