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

NCT03767530 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-05-08

No results posted yet for this study

Summary

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

  • Meibomian Gland Dysfunction

Interventions

DEVICE

Mibo Thermoflo

Thermal therapy with Mibo Thermoflo for 11 minutes per eye, during each session.

OTHER

Warm compresses and eyelid massage

Warm compresses plus eyelid massage 2 times per day 11 minutes per eye.

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    collaborator OTHER

  • Universidad Autonoma de Nuevo Leon

    lead OTHER

Principal Investigators

  • Karim Mohamed-Noriega, M.D. · Departamento de Oftalmologia, Hospital Universitario Dr. Jose Eleuterio Gonzalez

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2025-09-20
Completion
2027-12-20

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03767530 on ClinicalTrials.gov