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

NCT03104894 | Completed

• 1 other identifier: 0137-13-BRZ
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

MGD-Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Study Group

EXPERIMENTAL

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

Procedure: Meibomian Glands Massage; Device: Meibomian Massage device

Control Group

SHAM COMPARATOR

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

Procedure: Sham Meibomian Glands Massage

Interventions

Meibomian Glands Massage PROCEDURE

Meibomian gland expression

Study Group

Sham Meibomian Glands Massage PROCEDURE

Touching the eyelids gently

Control Group

Meibomian Massage device DEVICE

Meibomian glands expression with applicator

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Individuals (age≥18Y) with MGD levels 2-3 that are capable to make an informed decision about their participation in the trial.

You may not qualify if:

• pregnant women, subjects who received prior Meibomian gland massage.

Sponsors & Collaborators

• Barzilai Medical Center: lead

Study Sites (1)

Barzilai Medical Center

Ashkelon, Is, 78278, Israel

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: April 7, 2017
• Study Start: August 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 23, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)