Acupuncture Combined With Artificial Tears Compared With Artificial Tears Alone in Moderate Dry Eye: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Ocular Surface Disease Index (OSDI) Score
研究概览
简要总结
This randomized clinical trial was designed to evaluate the effectiveness of acupuncture combined with artificial tears compared to artificial tears alone in patients with moderate dry eye disease. A total of 90 participants were enrolled at the University of Health Sciences, Ankara Training and Research Hospital. Patients were randomly assigned to receive either artificial tears only or artificial tears with acupuncture. Acupuncture was performed twice weekly for ten sessions by a certified specialist.
Assessments were conducted at baseline, after treatment, and at one-month follow-up using the Ocular Surface Disease Index (OSDI), Schirmer test, and tear break-up time (tBUT). The primary outcome measure was the change in OSDI score, while secondary outcomes included Schirmer test values and tBUT.
详细描述
Dry eye disease (DED) is a chronic ocular surface disorder characterized by instability of the tear film, ocular discomfort, and visual disturbance. It significantly impairs quality of life, limiting daily activities such as reading, driving, and computer use. Standard treatments, including artificial tears and anti-inflammatory agents, often provide only partial or temporary relief and may not adequately address the underlying inflammatory mechanisms. As a complementary approach, acupuncture has been suggested to improve lacrimal gland function, enhance tear secretion, and reduce ocular inflammation, yet comparative evidence in moderate DED remains limited.
The aim of this study was to evaluate the short-term efficacy of acupuncture combined with artificial tears compared to artificial tears alone in patients with moderate DED. This prospective, randomized, controlled, parallel-group trial was conducted at the University of Health Sciences, Ankara Training and Research Hospital. Ninety adults aged 18-65 years, diagnosed with moderate DED according to TFOS DEWS II criteria (Schirmer 5-10 mm and tear break-up time 6-10 seconds), were enrolled between January 2024 and May 2025. Participants were randomly allocated to two groups: Group 1 received artificial tears only, while Group 2 received artificial tears plus acupuncture.
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
- None
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
- •Age between 18 and 65 years
- •Diagnosis of moderate dry eye disease according to TFOS DEWS II criteria
- •Anesthetized Schirmer test result between 5-10 mm
- •Tear break-up time (tBUT) between 6-10 seconds
- •Ocular Surface Disease Index (OSDI) score ≥ 13
- •Symptom duration of at least 3 months
- •Signed informed consent form
排除标准
- •Sjögren's syndrome, active blepharitis, or meibomian gland dysfunction
- •Systemic rheumatologic, autoimmune, or metabolic disease (e.g., diabetes)
- •Use of systemic or topical treatment for dry eye within the last 6 months
- •Previous ocular surgery
- •Contact lens use
- •Pregnancy or lactation
- •History of neurological or psychiatric disorders
研究组 & 干预措施
Artificial Tears Only
Participants received topical artificial tears (sodium hyaluronate/CMC-based eye drops) according to standard treatment protocol. No additional intervention was given.
干预措施: Artificial tears (Drug)
Experimental: Artificial Tears + Acupuncture
Participants received artificial tears plus acupuncture therapy, administered by a certified specialist, twice weekly for 10 sessions. Each session lasted 20 minutes.
干预措施: Artificial tears (Drug)
Experimental: Artificial Tears + Acupuncture
Participants received artificial tears plus acupuncture therapy, administered by a certified specialist, twice weekly for 10 sessions. Each session lasted 20 minutes.
干预措施: Traditional Chinese Medicine Acupuncture (Other)
结局指标
主要结局
Change in Ocular Surface Disease Index (OSDI) Score
时间窗: Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9)
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire used to assess the severity of dry eye symptoms and their impact on visual function. Scores range from 0 to 100, with higher scores indicating more severe disease. The primary outcome is the change in OSDI score from baseline to post-treatment and 1-month follow-up.
次要结局
- Change in Schirmer Test Values(Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9))
- Change in Tear Break-Up Time (tBUT)(Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9))
研究者
Nadide Koca
Principal Investigator, M.D., Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital
Ankara Training and Research Hospital