The Effect of Gland Expression on the Regeneration of Meibomian Gland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Meibomian gland dropout percentage
研究概览
简要总结
The goal of this clinical trial is to compare the percentage of meibomian gland (MG) dropout in patients who are treated with additional meibomian gland expression (MGX) and in patients who are not. The main question[s] it aims to answer are:
- Does additional MGX reverse MG dropout and support regeneration of MG?
- Does additional MGX have better effect on tear film stability, MG function, lid morphology, tear cytokines than lid hygiene alone?
Methods:
Participants will be randomly assigned into MGX group as a treatment group and control group to assess study outcomes. The basic treatment of the 2 groups included lid hygiene once daily and artificial tear. The treatment duration lasts for 12 weeks. Patients will be examined at baseline, at 4-week, 8-week, 12-week visit for MG dropout percentage, MG morphology, lid margin abnormalities, Meibum assessment, tear film, tear cytokines and pain score to see if additional MGX can regenerate MG better than lid hygiene alone.
详细描述
- Study design: an assessor-blinded, randomized, controlled trial
- Target population: MGD patients having mild to moderate MG dropout from Out-clinic at King Chulalongkorn Memorial Hospital (KCMH).
- Randomization and blinding Permuted block randomization will be used. After recruiting in this study, participants who meet the eligibility criteria will be divided into 2 groups by research assistant. There is an independent ophthalmologist (A.L) who is blinded to treatment allocation.
5)Data collection Demographic characteristics, numeric rating scale-11 (NRS-11) and ocular surface disease index (OSDI) will be collected by interviewing. Other parameters will be collected by slit lamp examination, specific machines or further investigations. All the data will be filled in the medical record. The participants will be identified on medical record by a unique research number, not by name or identification (ID) number (apart from on the consent form and enrollment log). Patient's ID, name, surname, and phone number will be stored in different file by the research assistant. The data will be locked up and destroyed 5 years after the study ends.
When the patients are recruited in the study, the patients will be provided information sheet and explained about the study. If the patients agree to participate in the study, they will be asked to sign the consent form. Then, they will be appointed to return to the Refractive Surgery Center in the next day for examination and tear collection between 1 pm to 3 pm because some cytokines are independent diurnal rhythms.
All outcome data will be collected by one single masked investigator (A.L). The data will be collected at 4 time points (day 0, week 4, week 8 and week 12). At baseline and 12-week post treatment, participants are required to be at the hospital on time within the period of 1 pm to 3 pm for tear collection. In each visit, the examination must be done in correct order in order not to avoid the results of outcomes. These steps include:
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of obstructive MGD
- •Visible Meibomian gland dropout of upper and lower eyelid from grade 1 to grade 2 (Arita's meiboscale)
- •If both eyes meet above criteria, only right eye is chosen
排除标准
- •Diagnosis with secondary MGD
- •Having any eyedrop other than eye lubricant within the last 3 months
- •Any kind of eyelid treatment related to MGD within the last 6 months
- •History of ocular trauma, ocular surface surgery or eyelid surgery
- •History of intraocular surgery less than 6 months
- •Eyelid botulinum toxin injection within the last 6 months
- •Ocular diseases other than dry eye
- •Pregnant or breast-feeding
- •Wearing contact lens
- •Using any hormones therapy, anti-inflammatory drugs, tetracycline and macrolides
- •Refuse to participate in the study
结局指标
主要结局
Meibomian gland dropout percentage
时间窗: Baseline, week 4, week 8, week 12
The dropout percentage of upper and lower eyelid is calculated by (Area of Meibomian gland dropout) / (Area of tarsal plate)\*100%. Non-contact infrared Meibography is carried out using Oculus Keratograph 5M with upper and lower eyelids everted consecutively. To calculate the dropout area percentage of each eyelid, the investigator analyzes the images by utilizing the ImageJ software.
次要结局
- Meibomian gland morphology(Baseline, week 4, week 8, week 12)
- Lipid layer thickness(Baseline, week 4, week 8, week 12)
- Lid margin abnormality(Baseline, week 4, week 8, week 12)
- Meibum quality(Baseline, week 4, week 8, week 12)
- Meibum expressibility(Baseline, week 4, week 8, week 12)
- Pain level(Baseline, week 2, week 4, week 6, week 8, week 10)
- Adverse events(week 4, week 8 and week 12)
研究者
Ngoc Van Anh Le, MD
Principal Investigator
Chulalongkorn University