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

NCT ID: NCT03767530

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

Dry eye syndrome is considered one of the most important ophthalmologic diseases, affecting 10 to 20% of the general population. Of these, 3.7% to 70% of cases are due to meibomian gland dysfunction (MGD). MGD is a chronic diffuse disease characterized by terminal duct obstruction and/or qualitative/quantitative changes in gland secretion. This causes a disruption in the tear film, ocular irritation symptom, inflammation, and ocular surface symptoms. The gold standard for the treatment of meibomian dysfunction is the use of warm compresses and eyelid massage 2 times a day. These have variable results and consequently patient's adherence to treatment is low. An alternative treatment is the use of thermal therapy devices such as Lipiflow, MiBo Thermoflo, and Blephasteam. The objective of this study is to determine if the thermal device MiBo Thermoflo is more effective than warm compresses and eyelid massage in the treatment of dry eye secondary to MGD. Participants will be randomly assigned to one of two groups: 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 follow up of 24 weeks and we will compare results for both groups at the end of the study. During the protocol patients in both groups will continue with their standard treatment for dry eye as needed.

Conditions

Meibomian Gland Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mibo Thermoflo (thermal device)

3 sessions at 2 weeks interval (basal, week 2, week 4)of 11 minutes per eye of thermal therapy with Mibo Thermoflo.

Group Type: EXPERIMENTAL

Mibo Thermoflo

Intervention Type: DEVICE

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

Warm compresses and eyelid massage

2 times per day, 11 minutes per eye.

Group Type: ACTIVE_COMPARATOR

Warm compresses and eyelid massage

Intervention Type: OTHER

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

Interventions

Mibo Thermoflo

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

Intervention Type: DEVICE

Warm compresses and eyelid massage

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with:

• Dry eye syndrome with meibomian gland dysfunction alone or in combination of other type of dry eye.
• Patients who were previously treated with eyelid massages and warm compresses without any improvement.

Exclusion Criteria

• Pregnant women.
• History of ocular surgery within three months prior to inclusion.
• History of trauma, infection or inflammation within three months prior to inclusion.
• Contact lens use in the last week before inclusion.
• Patients with active ocular allergic disease.
• Patient with microbial keratitis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez

OTHER

Sponsor Role: collaborator

Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role: lead

Responsible Party

Karim Mohamed-Noriega

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karim Mohamed-Noriega, M.D.

Role: PRINCIPAL_INVESTIGATOR

Departamento de Oftalmologia, Hospital Universitario Dr. Jose Eleuterio Gonzalez

Locations

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

Monterrey, Nuevo León, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Karim Mohamed-Noriega, M.D.

Role: CONTACT

karim.mohamednrg@uanl.edu.mx,drkmohamed1@gmail.com

+52 8183469259

Facility Contacts

Karim Mohamed-Noriega, M.D.

Role: primary

karim.mohamednrg@uanl.edu.mx, drkmohamed1@gmail.com

+52 81 83469259

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Other Identifiers

OF18-00006

Identifier Type: -

Identifier Source: org_study_id