Dry Eye Disease, Meibomian Gland Dysfunction
Conditions
Keywords
Dry Eye, Thermal Therapy, Meibomian Gland Dysfunction
Brief summary
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
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.
Interventions
DEVICEThermal therapy device
Thermal therapy of blocked Meibomian glands
Sponsors
UMay Care Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds | Before and after 4 weeks of daily treatment | Ocular surface analysis of tear film evaporation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) Score | Before and after 4 weeks of daily treatment | Standardized symptom questionnaire |
| Meibum Expressibility | Before and after 4 weeks of daily treatment | Grade of Meibum oil expressibility from Meibomian Gland |
| Sleep Quality | Before and after 4 weeks of daily treatment | Pittsburg Sleep Quality Index (PSQI) |
| State Trait and Anxiety | Before and after 4 weeks of daily treatment | State-Trait Anxiety Index (STAI) |
Contacts
Primary ContactSharmin Habib, OD
Outcome results
None listed