RecruitingNot ApplicableNCT03767530

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


Sponsor

Universidad Autonoma de Nuevo Leon

Enrollment

42 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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.

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Interventions

DEVICEMibo Thermoflo

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

OTHERWarm compresses and eyelid massage

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


Locations(1)

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

Monterrey, Nuevo León, Mexico

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NCT03767530


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