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Single-center, Prospective, Open Label, with Before-After Study Design, to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease.
Single-center, Prospective, Open Label, with Before-After Study Design. Up to 15 subjects will be enrolled in the study to provide at least 10 evaluable subjects.
All subjects will undergo 3 treatments two weeks apart (2 weeks (+/-3 days) from the previous treatment).
Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Demaod VR system tratment | Experimental | Non-invasive light pulse generated by a non-contacting device for treating the symptoms of dry eyes and MDG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR system by Demaod | Device | non-invasive light pulse generated by a non-contacting device for the treatment of the symptoms of dry eyes and MDG |
|
| Measure | Description | Time Frame |
|---|---|---|
| 4 weeks TBUT change from baseline | Change from baseline to the 4-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater. | up to 4 weeks post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| OSDI changes from baseline to 4 and 12 weeks FU | Change from baseline in patient symptoms using Ocular Surface Disease Index (OSDI) at 4-weeks and 12-weeks follow-up exam. | up to 12 weeks post last treatment |
| 12 weeks TBUT change from baseline |
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Inclusion Criteria:
Exclusion:
Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hila Kfir, b.sc | Contact | 0523313350 | Kfirclinical@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemek Medical Center | Recruiting | Afula | 3824674 | Israel |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Single-center, Prospective, Open Label, with Before-After Study Design
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no masking during this study.
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Changes from baseline to the 12-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.
| 12 weeks post last treatment |