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The goal of this study is to compare which treatment - BlephEx or MiBoFlo - will be a better option for patients suffering from dry eye secondary to Meibomian Gland dysfunction.
The investigators have previously studied the effect of the BlephEx instrument (debridement of lid debris) in relieving signs and symptoms of blepharitis (Connor CG et al, ARVO 2014). This previous study demonstrated positive results from the BlephEx treatment. Warming the eyelids (e.g., using warm wash cloths) still remains a viable treatment option for this disease. However, patients are often non-compliant with warm compress therapy due to the requirement of performing it at least twice per day. The MiBoflo delivers uniform and consistent amounts of heat to the eyelid. It is suggested that two treatments over 30 days is adequate to relieve signs and symptoms of Meibomian gland dysfunction. This equipment is currently used in optometric practices in this country.
There are no clinical studies comparing BlephEx and MiBoflo as treatment options for blepharitis. Hence, the current study will provide new and useful information on which treatment option may be better for treating blepharitis and Meibomian gland dysfunction. Part of this study will also investigate if a combination of BlephEx and MiBoflo treatments is more beneficial to the patient. The data generated will directly benefit clinical practice and impact several millions of patients who suffer from this Blepharitis and / or Meibomian gland dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BlephEx treatment | Active Comparator | Treatment with the BlephEx instrument (lid margin exfoliation) |
|
| MiBoFlo treatment | Active Comparator | Treatment with the MiboFlo equipment (heat therapy to eyelids) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blephex | Device | Lid margin exfoliation |
| |
| MiboFlo |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular irritation symptoms (OSDI Questionnaire score) | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Tear break-up | one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srihari Narayanan, OD, PhD | University of the Incarnate Word | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rosenberg School of Optometry | San Antonio | Texas | 78229 | United States |
No plan to share IPD to other researchers
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 29, 2020 | |
| Reset | Apr 10, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 29, 2020 | Apr 10, 2020 |
| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| Device |
Lid warming treatment |
|