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The goal of this clinical trial is to evaluate the Eye Lipid Mobilizer (ELM) for the treatment of evaporative dry eye disease associated with meibomian gland dysfunction. The main questions aim to confirm that 1) the ELM can meet its intended use by validated patient reporting outcomes and 2) to confirm that the ELM device can be used safely by different users within a clinical environment as determined by review of any adverse events related to the use of the device.
The purpose of the clinical study is to evaluate the Eye Lipid Mobilizer for the treatment of evaporative Dry Eye Disease associated with Meibomian Gland Dysfunction. The objective of the study is to confirm that the Eye Lipid Mobilizer (ELM) can meet its intended use by validated patient reporting outcomes.
The secondary objective is the ELM device can be used safety with no adverse events. The Eye Lipid Mobilizer (ELM) System is intended for the application of localized heat and vibration therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ELM Treatment | Active Comparator | To undergo the ELM procedure, the subject will sit comfortably in an exam chair. The Headset and Eye Pads will be adjusted to fit comfortably over gently closed eyelids. The subject will rest their head back. The ELM will be turned on, and will be active for 15 minutes wherein patients will feel a warming sensation to their eyes and a gentle vibration. The ELM is then removed. |
|
| Daily ELM Treatment | Active Comparator | To undergo the ELM procedure, the subject will sit comfortably in an exam chair. The Headset and Eye Pads will be adjusted to fit comfortably over gently closed eyelids. The subject will rest their head back. The ELM will be turned on, and will be active for 15 minutes wherein patients will feel a warming sensation to their eyes and a gentle vibration. The ELM is then removed. Subject will take personalized ELM home and use it as directed on a daily basis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELM | Device | Treatment of dry eye with ELM device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related adverse events | Incidence of procedure-related adverse events will be assessed | one week, four weeks |
| Device-related adverse events | Incidence of device-related adverse events will be assessed | one week, four weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SPEED II Questionnaire for Dry Eye | Change in outcomes for SPEED II Questionnaire for Dry Eye compared to baseline | one week, four weeks |
| Slip Lamp Evaluation | Change of appearance of cornea under slit lamp evaluation compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Human Factors and Usability Evaluation | Patients will participate in an Acceptance VAS Questionnaire | one week, four weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CEO | Eyedetec | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EYEcenter Optometric | Citrus Heights | California | 95662 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25136628 | Result | Semeraro F, Forbice E, Braga O, Bova A, Di Salvatore A, Azzolini C. Evaluation of the efficacy of 50% autologous serum eye drops in different ocular surface pathologies. Biomed Res Int. 2014;2014:826970. doi: 10.1155/2014/826970. Epub 2014 Jul 22. | |
| 25030896 | Result | Finis D, Pischel N, Konig C, Hayajneh J, Borrelli M, Schrader S, Geerling G. [Comparison of the OSDI and SPEED questionnaires for the evaluation of dry eye disease in clinical routine]. Ophthalmologe. 2014 Nov;111(11):1050-6. doi: 10.1007/s00347-014-3042-z. German. |
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will not be publishing in ICMJE journals
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| one week, four weeks |
| Meibomian Gland Imaging | Change in meibomian gland under imaging compared to baseline | one week, four weeks |
| Lipid Layer Thickness | Change in thickness of lipid layer compared to baseline | one week, four weeks |
| Tear Break Up Time | Change in tear break up time compared to baseline | one week, four weeks |
| Corneal Fluorescein Staining | Change in appearance of fluorescein staining compared to baseline | one week, four weeks |
| 19668387 | Result | Savini G, Prabhawasat P, Kojima T, Grueterich M, Espana E, Goto E. The challenge of dry eye diagnosis. Clin Ophthalmol. 2008 Mar;2(1):31-55. doi: 10.2147/opth.s1496. |