The Effect of Eyelid Support Plate Assisted Eyelid Massage on Meibomian Gland Dysfunction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Mean change from baseline in Ocular Surface Disease Index (OSDI) score at week 8
研究概览
简要总结
This study aims to conduct a randomized controlled clinical trial to compare the efficacy of a new type of massage device - eyelid support plate and glass rod assisted eyelid massage in improving MGD related dry eye symptoms, and evaluate the comfort and efficiency of both treatments, providing evidence-based support for clinical work
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate and sign an informed consent form;
- •Age range: 18 to 60 years old;
- •Meet the diagnostic criteria for dry eye in the International Society of Tears and Ocular Surface (TFOS) Dry Eye Symposium (DEWS) II ;
- •1/3 or more of the meibomian gland openings are blocked or the secretion characteristics of the meibomian gland are abnormal;
- •The best corrected visual acuity for each eye is ≥ 0.5;
- •Eye pressure (IOP) ≥ 5mmHg and ≤ 21mmHg per eye;
- •Women with reproductive potential agree to use reliable contraceptive methods during the study period;
- •Willing and able to complete all planned research visits and follow the guidance of the researchers.
排除标准
- •Contact lens use: Having used contact lenses within 14 days prior to the screening visit, or refusing to commit to discontinuing contact lens use during the study period (within the next 2 months);
- •Had undergone corneal refractive surgery (e.g., LASIK/SMILE), other corneal surgeries, cataract surgery, anti-glaucoma surgery, or fundoscopic surgery within 12 months prior to enrollment screening;
- •Participation in other medical studies within 3 months prior to enrollment screening;
- •Presence of any of the following active ocular diseases at present or within 3 months prior to screening: I) Acute allergic conjunctivitis; II) Infection (by bacteria, viruses, fungi, etc.); III) Inflammation (e.g., keratitis, retinitis).
- •Meningitis, choroiditis, uveitis, scleritis, etc.;
- •Eyelid abnormalities affecting eyelid function (such as ptosis, blepharospasm, entropion, ectropion, etc.);
- •Extensive ocular surface scars or conditions that may compromise ocular surface integrity (e.g., Stevens-Johnson syndrome, history of chemical burns, persistent corneal epithelial defects, history of ocular trauma, etc.);
- •Currently or previously diagnosed with glaucoma, or undergoing treatment with anti-glaucoma medications;
- •Has used any of the following ocular medications within the past 1 month: immunosuppressants, nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, or perfluorohexyloctane;
- •Has received any of the following non-pharmacological treatments for dry eye within the past month: meibomian gland massage, deep eyelid margin cleansing, intense pulsed light therapy, or thermal pulsation therapy;
- •During pregnancy or lactation;
- •Neurological or psychiatric disorders (moderate to severe anxiety, depression, and sleep disorders);
- •Uncontrolled ocular or systemic diseases;
- •History of epilepsy;
- •The investigator determines that the subject is not suitable for participation in this study.
结局指标
主要结局
Mean change from baseline in Ocular Surface Disease Index (OSDI) score at week 8
时间窗: Baseline, week 4, week 8
The OSDI is a 12-item patient-reported outcomes questionnaire, which to provide a rapid assessment of the range of ocular surface symptoms, including symptoms related to chronic dry eye, their severity, and their impact on the patient's ability to function.Each item is rated based on the frequency of symptoms in the past week: never (0 points) → sometimes (1 point) → half the time (2 points) → most of the time (3 points) → always (4 points),total score 0-100 points.The higher the score, the more obvious the dry eye symptoms.
次要结局
- Change in first non-invasive tear film break time(Baseline, week 4, week 8)