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Completed

NCT Number: NCT03104894

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

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.

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Key information

Conditions

MGD-Meibomian Gland Dysfunction Eye Diseases Eyelid Diseases Meibomian Gland Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barzilai Medical Center

Ashkelon, Is, 78278, Israel

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meibomian Glands Massage

Procedure

Meibomian gland expression

Sham Meibomian Glands Massage

Procedure

Touching the eyelids gently

Meibomian Massage device

Device

Meibomian glands expression with applicator

Primary outcomes

  1. Improvement in Tear Break up Time TBUT.

    Time frame: 1 month

    Tear break up time will be measured in seconds. The score is expected to be higher.

  2. Improvement in Ocular Surface Disease Index questionnaire score (OSDI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Barzilai Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2017
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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