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

Universidad Autonoma de Nuevo Leon

Status: Enrolling

Conditions: Meibomian Gland Dysfunction

Treatments: Other: Warm compresses and eyelid massage; Device: Mibo Thermoflo

Study type: Interventional

Funder types: Other

Identifiers

NCT03767530

OF18-00006

Details and patient eligibility

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

42 participants in 2 patient groups

Mibo Thermoflo (thermal device)

Experimental group

Description:

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

Treatment:

Device: Mibo Thermoflo

Warm compresses and eyelid massage

Active Comparator group

Description:

2 times per day, 11 minutes per eye.

Treatment:

Other: Warm compresses and eyelid massage