NCT05271422已完成不适用
A Single Center, Single-blind, Exploratory Study to Evaluate the Efficacy and Safety of the Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Who Are Scheduled for LASEK Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Changes in Tear break-up time (T-BUT)
研究概览
简要总结
This study aims to evaluate the efficacy and safety of applying pulse electrical stimulation around eye in dry eye disease patients who are scheduled for LASEK surgery.
详细描述
Duration of study period (per participant): Screening period (0-14 days), Intervention period (12 weeks), F/U period (2 weeks) Patient needs to visit site at least 9 times (Screening, baseline, V1, V2, V3, Tele-visit, V4, V5, F/U Tele-visit). Baseline visit will be done on the day of surgery. Visit 1, 2, 3, Tele-visit, 4, 5, F/U Tele-visit is 1 day, 3 days, 1 weeks, 2 weeks, 4 weeks, 12 weeks and 16weeks after baseline visit.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be 19 to 60 years of age, at the time of screening
- •Those who are scheduled to get LASEK surgery
- •According to the guidelines for diagnosing dry eye syndrome of Korean Corneal Disease Study Group, those who fall under Grade II or higher
- •Those with an OSDI score of 13 or higher
- •A person who has no pregnancy plan during the clinical trial period and has agreed to an effective contraceptive plan for Women of child bearing potential (WOCBP) by a doctor
- •A person who voluntarily agreed to participate in this clinical trial
排除标准
- •Patients who meet any of the exclusion criteria are excluded from this clinical trial.
- •A person with an uncontrollable systemic chronic disease (diabetes mellitus)
- •Those who are allergic to drugs such as Fluorescein Solution or ophthalmic anesthetics
- •In a case where there is a history of receiving ophthalmic surgery known to affect the tear layer within the last 6 months (e.g., Cataract, Pterygium surgery)
- •A person who takes systemic drugs (e.g., tetracycline derivatives, antihistamine, isotretinoin)
- •A person who has eyelid diseases or structural abnormalities
- •A person with acute eye infection or inflammation of the eyeball not related to Meibomian gland dysfunction
- •A person with abnormalities in the eyelids or eyelashes
- •A person with an eye condition or ophthalmic disease that is considered unsuitable for surgery (e.g., detachment of the retina, cataract)
- •Pregnant or lactating women
- •Those who can't understand or read the consent form of this clinical trial (e.g., illiterate or foreigners)
- •Any other cases that PI considers hard to participate in this clinical trial (e.g., heart-related problems, seizure, epilepsy. Patients transplanted metal or electronic device in head & neck. Patient suffering from unknown pain. Patients who are warned not to use our clinical trial device or is prohibited from using it (e.g., pacemaker user).)
结局指标
主要结局
Changes in Tear break-up time (T-BUT)
时间窗: Time Frame: baseline, 1, 4, 12 weeks
Check the changes in Tear break-up time (T-BUT)
Changes in Ocular Surface Disease Index (OSDI) score
时间窗: baseline, 1, 4, 12 weeks
Check the changes in Ocular Surface Disease Index (OSDI) score
次要结局
- Changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)(baseline, 1, 4, 12 weeks)
- Changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score(baseline, 1, 4, 12 weeks)
- Changes in LipiView Eye Lipid Layer Thickness(baseline, 4, 12 weeks)
- Changes in Matrix Metalloproteinase-9 (MMP-9) level(baseline, 4, 12 weeks)
- Changes in Tear Volume(baseline, 1, 4, 12 weeks)
- Changes in Visual Analogue Scale (VAS) score(baseline, 1 day, 3 days, 7 days)
- Changes in Staining Score(baseline, 1, 4, 12 weeks)
- Changes in Tear Osmolarity(baseline, 4, 12 weeks)
- Changes in the length of the aesthesiometer's filament in centimeters(baseline, 1, 4, 12 weeks)
研究者
研究点 (2)
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