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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Mexico
Departamento de Oftalmologia, Hospital Universitario Dr. Jose Eleuterio Gonzalez
RECRUITING
Monterrey
Contact Information
Primary
Karim Mohamed-Noriega, M.D.
karim.mohamednrg@uanl.edu.mx,drkmohamed1@gmail.com
+52 8183469259
Time Frame
Start Date: 2019-09-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 42
Treatments
Experimental: 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.
Active_comparator: Warm compresses and eyelid massage
2 times per day, 11 minutes per eye.
Related Therapeutic Areas
Sponsors
Leads: Universidad Autonoma de Nuevo Leon
Collaborators: Hospital Universitario Dr. Jose E. Gonzalez

This content was sourced from clinicaltrials.gov