The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye
NCT ID: NCT03104894
Last Updated: 2018-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2015-08-31
2017-12-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Study Group
The study group will receive meibomian glands massage and artificial drops PRN
Meibomian Glands Massage
Meibomian gland expression
Meibomian Massage device
Meibomian glands expression with applicator
Control Group
The control group will receive sham meibomian glands massage and artificial drops PRN.
Sham Meibomian Glands Massage
Touching the eyelids gently
Interventions
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Meibomian Glands Massage
Meibomian gland expression
Sham Meibomian Glands Massage
Touching the eyelids gently
Meibomian Massage device
Meibomian glands expression with applicator
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Barzilai Medical Center
OTHER
Responsible Party
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Locations
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Barzilai Medical Center
Ashkelon, Is, Israel
Countries
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Other Identifiers
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0137-13-BRZ
Identifier Type: -
Identifier Source: org_study_id
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