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

Primary Purpose

MGD-Meibomian Gland Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Meibomian Glands Massage
Sham Meibomian Glands Massage
Meibomian Massage device
Sponsored by
Barzilai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MGD-Meibomian Gland Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Barzilai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Study Group

Control Group

Arm Description

The study group will receive meibomian glands massage and artificial drops PRN

The control group will receive sham meibomian glands massage and artificial drops PRN.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 14, 2017
Last Updated
January 19, 2018
Sponsor
Barzilai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03104894
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barzilai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MGD-Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
patient will be assigned to the study/control group by randomization soft ware. The results will be documented and kept by the doctor who preforms the meibomian glands massage/ sham massage. All patients will receive study number. Follow up examination will be preformed by another doctor.
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
The study group will receive meibomian glands massage and artificial drops PRN
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
The control group will receive sham meibomian glands massage and artificial drops PRN.
Intervention Type
Procedure
Intervention Name(s)
Meibomian Glands Massage
Intervention Description
Meibomian gland expression
Intervention Type
Procedure
Intervention Name(s)
Sham Meibomian Glands Massage
Intervention Description
Touching the eyelids gently
Intervention Type
Device
Intervention Name(s)
Meibomian Massage device
Intervention Description
Meibomian glands expression with applicator
Primary Outcome Measure Information:
Title
Improvement in Tear Break up Time TBUT.
Description
Tear break up time will be measured in seconds. The score is expected to be higher.
Time Frame
1 month
Title
Improvement in Ocular Surface Disease Index questionnaire score (OSDI)
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Barzilai Medical Center
City
Ashqelon
State/Province
Is
ZIP/Postal Code
78278
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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

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