An interventional study of Thermal therapy device in Meibomian Gland Dysfunction and Dry Eye Disease, sponsored by UMay Care Inc.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-19.
Sponsored by UMay Care Inc. · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Heat application using at home thermal therapy device
Device: Thermal therapy device
Thermal therapy of blocked Meibomian glands
Also known as: umayREST
Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds
Ocular surface analysis of tear film evaporation
Time frame: Before and after 4 weeks of daily treatment
Change in Ocular Surface Disease Index (OSDI) Score
Standardized symptom questionnaire
Time frame: Before and after 4 weeks of daily treatment
Meibum Expressibility
Grade of Meibum oil expressibility from Meibomian Gland
Time frame: Before and after 4 weeks of daily treatment
Sleep Quality
Pittsburg Sleep Quality Index (PSQI)
Time frame: Before and after 4 weeks of daily treatment
State Trait and Anxiety
State-Trait Anxiety Index (STAI)
Time frame: Before and after 4 weeks of daily treatment
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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