Clinical trial NCT03104894: The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye
Official title: The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MGD-Meibomian Gland Dysfunction
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Tear Break up Time TBUT.
timeFrame: 1 month
measure: Improvement in Ocular Surface Disease Index questionnaire score (OSDI)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ashqelon
country: Israel
facility: Barzilai Medical Center
state: Is
Study officials:
References: