The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Improvement in Tear Break up Time TBUT.
研究概览
简要总结
The study aims to investigate whether combined treatment of MGD massage and artificial tears will improve signs and symptoms of dry eye compared to artificial tears alone.
The meibomian glands secrete meibum which is the oily component of the tear film layer. The meibum plays a pivotal role in preventing tear evaporation and smoothening the tears film .
Meibomian gland dysfunction is a common condition that affects 39%-50% of the population. It is part of inflammatory disease of the eyelids called blepharitis. Associated syndromes are rosacea and dry eye syndrome .
Sign and symptoms are: irritation, hyperemia, burning sensation, photophobia, epiphora and blur.
Spectrometry analysis shows change it the fatty acids conformation such as increase in levels of branched-chain fatty acids and decrease in saturated fatty acids .
Subsequently the clotted meibum results in glands blockage that can be graded in 0-4 grade scale: grade 2- meibum secretion thick and oily, grade 3- meibum secretion granular-toothpaste like.
Although MGD is not often accompanied with inflammatory signs it is a common cause for evaporative dry eye.
详细描述
In order to investigate the relation between meibomian gland massage outcomes and signs and symptoms of dry eye, randomized prospective study will be conducted. Patients, who arrive to Barzilai Medical Center out patients' clinic, are diagnosed with MGD 2-3 and signed informed consent form shall be included in the trial, then randomized to study group or control group.
The study group will receive meibomian glands massage and artificial drops PRN, whereas the control group will receive sham massage and artificial drops. Each visit at the clinic will include dry examinations and questionnaire.
Follow up examination are due after one week, monthly visits up to 4 months, then after half year, 8 months and one year.
Statistical methods: in order to evaluate to treatment effect T-Test analysis will be calculated, significant result is when P<0.05.
Data will be recorded into to electronic sheets. Subjects' confidentiality will be assured by masking any identifying details and a random number will be assigned prior results analysis stage
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
patient will be assigned to the study/control group by randomization soft ware. The results will be documented and kept by the doctor who preforms the meibomian glands massage/ sham massage. All patients will receive study number. Follow up examination will be preformed by another doctor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult Individuals (age≥18Y) with MGD levels 2-3 that are capable to make an informed decision about their participation in the trial.
排除标准
- •pregnant women, subjects who received prior Meibomian gland massage.
研究组 & 干预措施
Study Group
The study group will receive meibomian glands massage and artificial drops PRN
干预措施: Meibomian Glands Massage (Procedure)
Study Group
The study group will receive meibomian glands massage and artificial drops PRN
干预措施: Meibomian Massage device (Device)
Control Group
The control group will receive sham meibomian glands massage and artificial drops PRN.
干预措施: Sham Meibomian Glands Massage (Procedure)
结局指标
主要结局
Improvement in Tear Break up Time TBUT.
时间窗: 1 month
Tear break up time will be measured in seconds. The score is expected to be higher.
Improvement in Ocular Surface Disease Index questionnaire score (OSDI)
时间窗: 1 month
OSDI score will be calculated according a formula: (sum of scores) X 25 divided by the number of questions answered. The score is expected to be lower.
次要结局
未报告次要终点