NCT06120348招募中不适用
Multi-center, Placebo-controlled, Randomized, Parallel Design, Superiority, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of Application of Electrical Stimulation Around Eye After Laser Keratoplasty (LASEK) in Patients With Dry Eye Syndrome.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 12
- 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 after laser keratoplasty (LASEK) in patients with dry eye syndrome.
详细描述
Duration of study period (per participant): Screening period (0-4weeks). Intervention period (12weeks).
Patient needs to visit site at least 8 times (Screening, baseline, 1 day, 3day, 1, 4, 8, 12weeks based on baseline). Baseline visit will be done on the day of surgery.
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 (Participant)
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
- •Men and women aged 19 to 60
- •Those who are scheduled to get LASEK surgery
- •Those who have had dry eye symptoms for more than 3 months.
- •According to the guidelines for diagnosing dry eye syndrome of Korean Corneal Disease Study Group, those who fall under Grade II or higher
- •Those who TBUT test results of less than 10 seconds
- •Those who OSDI score of 13 or higher
- •Those who agreed to use contraception using a medically acceptable method during the period of clinical trial among Women of child bearing potential (WOCBP).
- •A person who voluntarily agreed to participate in this clinical trial.
排除标准
- •A person who has applied cyclosporin for the treatment of dry eye syndrome, drugs such as lipid-containing eye drops, topical steroid eye drops, IPL, etc., and medical devices for the treatment of dry eye syndrome within one month from the screening
- •A person with an uncontrollable systemic chronic disease.
- •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, Punctal plug insertion, Pterygium surgery)
- •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
- •A person who takes systemic drugs (e.g., tetracycline derivatives, antihistamine, isotretinoin)
- •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).)
- •Those who wore contact lenses within 72 hours before screening or who must wear contact lenses during the clinical trial period
- •Those who have taken the relevant systemic drugs (steroids, immunosuppressants, omega-3 and anticholinergic drugs, etc.) within 30 days from the date of screening
- •Those who are judged to have problems attaching electrodes due to inflammatory reactions or other dermatological problems in the skin around the orbit where the electrodes of medical devices are attached
- •Those who participated in other clinical trial within 30 days from the screening date
结局指标
主要结局
Changes in Tear break-up time (T-BUT)
时间窗: baseline, 12 weeks
Check the changes in Tear break-up time (T-BUT)
Changes in Visual Analogue Scale (VAS) score
时间窗: baseline, 1 week
Check the changes in Visual Analogue Scale (VAS) score
次要结局
- Changes in Tear break-up time (T-BUT)(baseline, 1, 4, 8 weeks)
- Changes in 5-Item Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease Index (OSDI) score(baseline, 1, 4, 8, 12 weeks)
- Changes in Visual Analogue Scale (VAS) score(baseline, 3 days, 4, 8, 12 weeks)
- Changes in Tear Volume(baseline, 1, 4, 8, 12 weeks)
- Changes in Staining Score(baseline, 1, 4, 8, 12 weeks)
- Changes in the length of the aesthesiometer's filament in centimeters(baseline, 1, 4, 8, 12 weeks)
研究者
研究点 (12)
Loading locations...
相似试验
招募中
不适用
Study of Application of Transcutaneous Pulsed Electrical Stimulation Around Eye in Age-related Macular DegenerationEarly to Moderate Dry Age-Related Macular DegenerationNCT05259371Nu Eyne Co., Ltd.25
已完成
不适用
Study of Application of Pulse Electrical Stimulation Around Eye in Glaucoma PatientsGlaucomaNCT05159414Nu Eyne Co., Ltd.18
已完成
不适用
Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK SurgeryDry Eye DiseaseNCT05271422Nu Eyne Co., Ltd.24
招募中
不适用
BCI Driving FES and Hand Orthosis for Upper Limb Rehabilitation in Chronic StrokeStroke, CerebrovascularHemiplegia and HemiparesisStroke/Brain AttackNCT06179745University of Essex32
招募中
不适用
Effect of Percutaneous Acupoint Electrical Stimulation on DeliriumDelirium, PostoperativeNCT06360549Qin Zhang238