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.

Study Overview

• Status: Completed
• Conditions: MGD-Meibomian Gland Dysfunction
• Intervention / Treatment: Procedure: Meibomian Glands Massage; Device: Meibomian Massage device; Procedure: Sham Meibomian Glands Massage

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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Is
    • Ashqelon, Is, Israel, 78278
      • Barzilai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Barzilai Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: April 2, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: 0137-13-BRZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No