Investigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction

Study Overview
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Brief Summary
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The purpose of this pilot study is to determine the feasibility of at home thermal therapy with a wireless, portable device, as an effective management of Meibomian Gland Dysfunction. This will be done by assessing patients for improvement in symptoms and ocular oil gland function after 4 weeks of a daily thermal therapy application.

Detailed Description
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This study will be a non-randomized, open label study of subjects with documented MGD. All subjects will be sent home with a wireless, portable thermal therapy device and examined pre and post treatment period. Subjects will be asked to use the device at bedtime for 5 minutes daily for 4 weeks. After treatment subjects will be re-examined and measured for clinical and symptomatic change in their MGD as well as changes to their sleep quality and anxiety index. Subjects will also be followed after treatment has been completed.

Official Title
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PILOT STUDY: The Effect of Thermal Therapy Using a Rechargeable, Wireless Device on Meibomian Gland Dysfunction

Conditions
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Meibomian Gland Dysfunction, Dry Eye Disease

Intervention / Treatment
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* Device: Thermal therapy device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of MGD Minimum age 18 years Exclusion Criteria: History of ocular disease, trauma, surgery (other than refractive), orbital cancer 3 month history of ocular infection and/or ocular inflammation not associated with dry eye 3 month history of any active physician administered or prescription dry eye treatment Pregnant, potentially pregnant or nursing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermal Therapy<br>Heat application using at home thermal therapy device | Device: Thermal therapy device<br>* Thermal therapy of blocked Meibomian glands<br>* Other names: umayREST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds | Ocular surface analysis of tear film evaporation | Before and after 4 weeks of daily treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ocular Surface Disease Index (OSDI) Score | Standardized symptom questionnaire | Before and after 4 weeks of daily treatment | 
| Meibum Expressibility | Grade of Meibum oil expressibility from Meibomian Gland | Before and after 4 weeks of daily treatment | 
| Sleep Quality | Pittsburg Sleep Quality Index (PSQI) | Before and after 4 weeks of daily treatment | 
| State Trait and Anxiety | State-Trait Anxiety Index (STAI) | Before and after 4 weeks of daily treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Thermal Therapy, Meibomian Gland Dysfunction