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| Name | Class |
|---|---|
| American Academy of Optometry | OTHER |
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The purpose of this study is to compare electronic debridement of the eyelid margin (BlephEx) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to Meibomian gland dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BlephEx | Experimental | The subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument. |
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| Manual debridement | Experimental | The subjects who are enrolled in this arm will undergo manual lid margin debridement using a stainless steel ophthalmic golf spud. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BlephEx | Device | Electronic lid margin debridement |
| |
| Manual debridement |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic relief | Betterment of symptoms (improvement in contact lens discomfort) will be measured using two different surveys - Ocular Surface Disease Index (OSID) and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The OSDI scores can range from 0 to 100. The CLDEQ-8 scores can range from 0 to 37. In both the questionnaires, a lowering of the score during follow-up visits represents a betterment of symptoms suffered by the patient. The numerical change in the scores on these two questionnaires will be documented as the change in symptom profile of the patient (betterment / worsening / stability). | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Meibography | Meibomian gland imaging will be performed to document any changes in the Meibomian gland during the study period. | 60 days |
| Lissamine green staining grade of the lid margin | The lid margin will be stained with Lissamine green dye. For the purpose of this study, Lissamine green staining of the eyelid margins will be graded from 0 to 4. (Zero representing "normal" or "no" staining; Four representing the highest degree of staining). During the course of the study, a decrease in lid margin staining will indicate a betterment of the health of the eyelid margin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srihari Narayanan, OD, PhD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rosenberg School of Optometry | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24145633 | Result | Korb DR, Blackie CA. Debridement-scaling: a new procedure that increases Meibomian gland function and reduces dry eye symptoms. Cornea. 2013 Dec;32(12):1554-7. doi: 10.1097/ICO.0b013e3182a73843. |
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There is no plan to share IPD.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2020 | Apr 10, 2020 | 2 |
| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| Device |
Manual lid margin debridement |
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| 60 days |
| Inflammatory activity | The presence or absence of Matrix Metalloproteinase-9 (MMP-9) in the tear fluid will be documented during the study visits. Presence of MMP-9 in the tear fluid indicates the presence of inflammatory activity in the tear fluid. | 60 days |
| Tear break-up time | Improvement in non-invasive tear break-up time measurement will be an objective outcome of the study. | 60 days |