Meibomian Gland Dysfunction
Conditions
Keywords
Dry eye
Brief summary
This study plans to learn more about the effectiveness of the TearRestore eyelid warming mask on signs and symptoms of Meibomian Gland Dysfunction (MGD). MGD is a leading cause of dry eye symptoms. Warm compresses are a standard treatment recommended by physicians to treat those diagnosed with MGD. The study will investigate whether the TearRestore mask affects meibomian gland function and dry eye symptoms.
Detailed description
The study will evaluate the effectiveness of the TearRestore eyelid warming mask on signs and symptoms of MGD. Warm compress treatments have been recommended as part of the standard of care by eye physicians, and are an important means in treating MGD. However, current treatment options suffer from varied temperature maintenance and poor compliance. The TearRestore™ mask offers patients a unique experience through providing sustained heat and the ability to see throughout the treatment, which will improve efficacy through improved compliance. If shown to be effective in altering Meibomian gland secretions at a single visit, this novel treatment could potentially offer the millions of patients suffering from MGD a more convenient and effective way to treat the condition.
Interventions
DEVICETear Restore Mask
The Tear Restore Mask will be used for 10 minutes
Sponsors
University of Colorado, Denver
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Adult participants (age 18-89) of any race, gender or ethnicity, diagnosed with meibomian gland dysfunction * Symptom score greater than eight on the SPEED questionnaire * Less than 75nm lipid layer thickness (LLT) utilizing the Lipiview II * Less than 10 second tear break up time (average of 3 measurements)
Exclusion criteria
* Participants with less than 6/15 meibomian glands yielding liquid secretions in either eyelid * Diagnosed with a systemic autoimmune condition including but not limited to Sjogren's or Lupus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Patient Evaluation of Eye Dryness (SPEED) Questionnaire | Up to 60 days | The SPEED questionnaire will be completed by the subject prior to using the Tear Restore Mask and then repeated after the 10 minute session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Layer Thickness | Up to 60 days | The Lipid Layer Thickness will be measured prior to using the Tear Restore Mask using the Lipiview II machine and then repeated following the 10 minute session. |
| Tear Breakup Time | Up to 60 days | The Tear Breakup Time will be measured prior to using the Tear Restore Mask by the Clinician and then repeated following to 10 minute session. |
| Number of Meibomian Glands Yielding Liquid Secretions | Up to 60 days | The Number of Meibomian Glands Yielding Liquid Secretions will be counted by the clinician prior to using the Tear Restore Mask and then recounted by the clinician following to 10 minute session. |
Countries
United States
Outcome results
None listed