Acupuncture for Dry Eye: a Multicenter Randomized Controlled Trial With Active Comparison Intervention (Artificial Tear Drop) Using a Mixed Method Approach
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
The purpose of this study is to assess whether acupuncture is more effective than artificial tear drop in the treatment of dry eye.
详细描述
Dry eye is one of the common diseases in ophthalmology. It affects not only patients' daily activities such as reading, carrying out professional work, using the computer, watching television, and driving, but also bodily health conditions such as bodily pain, discomfort and lower energy and vitality.
Currently, artificial tears are easily subscribed or used in the shape of OTC drugs. However, preservatives in artificial tears may exacerbate ocular surface inflammation and the safety of anti-inflammatory treatment is not well established.
Acupuncture, one of the most popular CAM interventions, showed some favourable effects over artificial tears for dry eye in several randomised controlled trials (RCTs). The evidence obtained from these trials is quite limited because all of these RCTs were conducted under high risk of biases. Therefore, well-designed RCTs are needed to establish the efficacy of acupuncture for dry eye.
In a clinical trial, cost-effectiveness and qualitative researches can be carried out parallely. Through this kind of mixed method approaches, various compartments, consisting acupuncture treatment effects are able to be revealed totally.
In this context, the investigators designed a multi-center randomized controlled trial, comparing acupuncture treatment and artificial tear drop with immunoassay for the change of tear cytokine concentration, cost effectiveness study and qualitative research in a mixed method approach.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 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 (ICD-10 : H04.1). He or she must have both of the conditions below:
- •Patients who have dry eye symptoms such as itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing
- •Patients whose tear film break-up time is below 10 seconds and Schirmer I test results is below 10mm/5sec.
排除标准
- •Patients who have defects of the eyelid or eyelashes
- •Acute infection of the eyelid, eyeball or eye accessories
- •Stevens-Johnson syndrome
- •Vitamin A deficiency
- •Eye or accessory defects due to external injuries
- •A past history of surgical operation related to the eye in last three months
- •Punctual occlusion
- •Current usage of contact lenses
- •Sequelae of facial palsy,
- •Current usage of anti-inflammatory eye drops in the last two weeks
- •Pregnancy
- •Using history of traditional medicinal treatment such as acupuncture, moxibustion and herbal medicine in the last one month
研究组 & 干预措施
Acupuncture
干预措施: Acupuncture (Device)
Artificial tear drop
干预措施: Refresh Plus (Drug)
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: Up to 13 weeks
This questionnaire is a 12-item instrument for ocular irritation and impact on visual function in dry eye sufferers. It can provide quantifiable results of dry eye symptom frequency and vision-related functioning. Korean version of the OSDI questionnaire will be used. Follow up measurement will be assessed after 4, 5, 9 and 13 weeks from the first visit.
次要结局
- Visual analogue scale (VAS) for self-assessment of ocular discomfort(Up to 13 weeks)
- Schirmer I test with anaesthesia(Up to 13 weeks)
- Tear Film Break Up Time (BUT)(Up to 13 weeks)
- General Assessment by acupuncture practitioner and participants(Up to 5 weeks)
- Self reports about experiences of using other dry eye-related treatments after the end of each intervention.(Up to 13 weeks)
- Quality of life (QOL)(Up to 13 weeks)
- Case reports on adverse events for the evaluation of safety(Up to 13 weeks)
- Qualitative analysis (additional study)(Up to 13 weeks)
- Cost-effectiveness analysis between acupuncture and artificial tear drop treatment (additional study)(Up to 13 weeks)