Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03767530

Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction

Led by Universidad Autonoma de Nuevo Leon · Updated on 2026-05-08

42

Participants Needed

1

Research Sites

433 weeks

Total Duration

On this page

Sponsors

U

Universidad Autonoma de Nuevo Leon

Lead Sponsor

H

Hospital Universitario Dr. Jose E. Gonzalez

Collaborating Sponsor

AI-Summary

What this Trial Is About

Dry eye syndrome is a common eye disease that affects 1 to 2 out of 10 persons around the planet. One common cause of this disease is the meibomian gland dysfunction. Meibomian glands are very small glands located at the rim of the eyelids that produce an oily substance that prevents the evaporation of tears. When these glands are compromised, the tear film evaporates quickly and the eyes dry up. This disease presents as eye irritation, foreign body sensation, inflammation, etc. The treatment of choice for MGD is eyelid massage and warm compresses 2 times a day. However, these treatments not always work perfectly, and as a result, patients find it hard to follow doctor's orders. Another kind of treatment is thermal therapy. There are several devices that are designed to apply heat on the eyelids, such as Lipiflow, MiBo Thermoflo, and Blephasteam. In this study, we want to find out whether thermal therapy with MiBo Thermoflo works better than warm compresses and eyelid massage use in the treatment of dry eye caused by MGD. To do this, we will select several patients and will assign them randomly to either the group with thermal therapy with MiBo Thermoflo or to the group with warm compresses and eyelid massage. The Mibo group will receive 3 sessions of thermal therapy at 2 weeks interval and the control group warm compresses and eyelid massage 2 times per day. All subjects will have a follow up of 24 weeks and we will compare results for both groups at the end of the study.

CONDITIONS

Official Title

Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with dry eye syndrome due to meibomian gland dysfunction alone or combined with other dry eye types
  • Previously treated with eyelid massages and warm compresses without improvement
Not Eligible

You will not qualify if you...

  • Pregnant women
  • History of eye surgery within the last three months
  • History of eye trauma, infection, or inflammation within the last three months
  • Contact lens use within the last week
  • Active ocular allergic disease
  • Microbial keratitis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico, 64460

Actively Recruiting

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Research Team

K

Karim Mohamed-Noriega, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction | DecenTrialz