The Effect of Laser Acupuncture on the Signs and Symptoms of Dry Eye Disease Due to Visual Display Terminal Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The Ocular Surface Disease Index
研究概览
简要总结
The purpose of this clinical trial is to determine whether laser acupuncture can alleviate dry eye symptoms caused by visual display terminal use and to assess the safety of laser acupuncture. The research questions to be addressed are:
- Can laser acupuncture and artificial tears reduce the Ocular Surface Disease Index (OSDI) score, Tear Break-Up Time (TBUT) score, Ocular Surface Staining (OSS) score, and Schirmer Test score?
- Are there any side effects associated with laser acupuncture therapy?
The researchers will compare laser acupuncture and artificial tears with sham laser acupuncture (a procedure using the same device but without activating the laser, so no energy is emitted) to assess whether laser acupuncture and artificial tears can effectively treat dry eye associated with visual display terminal use.
Participants will:
- Receive either laser acupuncture therapy or sham laser acupuncture therapy for 6 sessions, twice a week, over a 3-week period.
- Use artificial tears daily, 4 times per day (morning, afternoon, evening, and night), with one drop per eye for both eyes, over a 4-week period.
- Attend follow-up visits at the eye clinic at baseline (before therapy), in week 2, and in week 4.
- Record any side effects observed after each session of laser acupuncture therapy.
详细描述
- Dry eye disease is an ocular condition characterized by common symptoms such as eye irritation, a sensation of grittiness, foreign body sensation, stickiness, itchiness, eye fatigue, redness, stabbing or burning sensations, increased blinking frequency, and symptom exacerbation in the afternoon or evening.
- Visual Display Terminal (VDT) refers to devices equipped with a screen for displaying graphics or digital content for specific tasks, commonly known as gadgets. Examples of VDTs include computers, laptops, televisions, and mobile phones.
- The Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions designed to assess symptoms of dry eye, visual function, and environmental factors that may trigger dry eye.
- The Visual Analog Scale (VAS) is a scoring tool to measure the intensity of discomfort associated with dry eye, using a scale from 0 to 100, where 0 indicates "no pain/discomfort" and 100 indicates "the most severe pain/discomfort."
- Tear Break-Up Time (TBUT) is an examination used to assess how long the tear film remains on the ocular surface after blinking, as a measure for diagnosing dry eye. This test is conducted by an ophthalmologist.
- Ocular Surface Staining (OSS) is an examination in which dye is applied to the ocular surface to detect abnormalities on the eye's surface. This test is also performed by an ophthalmologist.
- The Schirmer test is a quantitative test used to measure tear volume over a period of 5 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participants, the ophthalmologist conducting the eye examinations, and the outcome assessors will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 - 59 years with dry eye complaints
- •Diagnosed with DED by an Ophthalmologist with the criteria OSDI value ≥ 13, and TBUT value < 10 seconds
- •Using VDT for at least 4 hours a day
- •Not currently receiving other DED therapy other than CMC artificial tears
- •Willing to participate in the study until completion and sign the informed consent
排除标准
- •Acute infection or trauma to the eye and periorbita
- •Eyelid abnormalities or facial paresis that prevent the eye from closing
- •History of intraocular or extraocular surgery within the last 12 months
- •Previously diagnosed with Steven Johnson Syndrome, Sjogren Syndrome, or diabetes mellitus
- •Undergoing chemotherapy or post-chemotherapy
- •Pregnant and lactating women
- •Menopausal women or those receiving hormone therapy
- •History of uncontrolled seizures or epilepsy
研究组 & 干预措施
Intervention Group
The laser acupuncture and artificial tears therapy
干预措施: The laser acupuncture and artificial tears therapy (Device)
Control Group
The sham laser acupuncture and artificial tears therapy
干预措施: The sham laser acupuncture and artificial tears therapy (Device)
结局指标
主要结局
The Ocular Surface Disease Index
时间窗: Before therapy, week 2, week 4
The Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions designed to assess symptoms of dry eye, visual function, and environmental factors that may trigger dry eye.
The Tear Break-up Time
时间窗: Before therapy, week 2, week 4
Tear Break-Up Time (TBUT) is an examination used to assess how long the tear film remains on the ocular surface after blinking, as a measure for diagnosing dry eye. This test is conducted by an ophthalmologist.
次要结局
- Adverse Event(Up to week 4)
- The Ocular Surface Staining Score(Before therapy, week 2, week 4)
- The Schirmer Score(Before therapy, week 2, week 4)
- The Visual Analog Scale(Before therapy, week 2, week 4)
研究者
Inria Chandra
Resident of Medical Acupuncture Study Program
Indonesia University