The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye

Conditions
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MGD-Meibomian Gland Dysfunction

Intervention / Treatment
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* Procedure: Meibomian Glands Massage
* Procedure: Sham Meibomian Glands Massage
* Device: Meibomian Massage device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Individuals (age≥18Y) with MGD levels 2-3 that are capable to make an informed decision about their participation in the trial. Exclusion Criteria: pregnant women, subjects who received prior Meibomian gland massage.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>The study group will receive meibomian glands massage and artificial drops PRN | Procedure: Meibomian Glands Massage<br>* Meibomian gland expression<br>Device: Meibomian Massage device<br>* Meibomian glands expression with applicator<br>|
| Sham Comparator: Control Group<br>The control group will receive sham meibomian glands massage and artificial drops PRN. | Procedure: Sham Meibomian Glands Massage<br>* Touching the eyelids gently<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Tear Break up Time TBUT. | Tear break up time will be measured in seconds. The score is expected to be higher. | 1 month | 
| Improvement in Ocular Surface Disease Index questionnaire score (OSDI) | 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. | 1 month |