Using thermal devices to treat meibomian gland dysfunction

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

This study is testing if a new thermal therapy device can help people with dry eye caused by meibomian gland dysfunction feel better compared to regular warm compresses and eyelid massage.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universidad Autonoma de Nuevo Leon (other)
• Locations: 1 site (Monterrey, Nuevo León)
• Trial ID: NCT03767530 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of the MiBo Thermoflo thermal therapy device compared to traditional warm compresses and eyelid massage for treating meibomian gland dysfunction, a common cause of dry eye syndrome. Participants diagnosed with dry eye syndrome due to meibomian gland dysfunction will be randomly assigned to receive either thermal therapy or standard treatment. The study will involve three sessions of thermal therapy over a two-week period, with follow-ups extending for 24 weeks to assess outcomes. The goal is to determine if thermal therapy provides better relief from symptoms than conventional methods.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with dry eye syndrome specifically due to meibomian gland dysfunction who have not improved with standard treatments.

Not a fit: Patients with recent ocular surgery, active ocular infections, or those using contact lenses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and convenient option for patients suffering from meibomian gland dysfunction.

How similar studies have performed: Other studies have shown promise with thermal therapy for dry eye conditions, suggesting this approach may be effective.

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.

Where this trial is running

Monterrey, Nuevo León

• Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey, Nuevo León, Mexico (RECRUITING)

Study contacts

• Principal investigator: Karim Mohamed-Noriega, M.D. — Departamento de Oftalmologia, Hospital Universitario Dr. Jose Eleuterio Gonzalez
• Study coordinator: Karim Mohamed-Noriega, M.D.

Conditions: Meibomian Gland Dysfunction, Meibomian gland dysfunction, Mibo, MGD, Dry eye disease, Thermic devices