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Dry Eye disease signs and symptoms are reduced in patients who receive topical steroids and topical hyaluronic acid.
AdOM's Tear Film Imager measurements are reproducible and it can diagnose the dry eye disease state in a single, non-invasive measurement. The Tear Film Imager can provide objective accurate measurements of the dry eye treatment effectiveness.
80 subjects will be enrolled , 40 of which with positive signs and symptoms of Dry eye and 40 healthy subjects without sign and no symptoms of Dry eye. Healthy and Dry eye groups will be age- matched.
Over a period of 4 weeks, the subjects diagnosed with dry eye will be treated and as follows:
Both groups will be examined at baseline and 4 weeks after baseline measurement.
Treatment results will be measured by both traditional methods and by Tear Film Imager.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry Eye Disease | Experimental | Subjects who will be diagnosed at baseline with Dry Eye Disease according to standard diagnosis |
|
| Healthy | Active Comparator | Subjects who will be diagnosed at baseline with no Dry Eye Disease according to standard diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tear Film Imager | Device | Tear Film Imager recording |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear film imager measurements with be assessed for reference values for objective tests of the disease with the Tear Film Imager | Tear film imager meuresmend will be assessed during the study visits | 1month |
| Verify repeatability of Tear film imager measurement | The repeatability of TFI will be evaluated by comparing the reported parameters of the two TFI measurements on first visit | 2 hours |
| Compare the clinical measurements of DES to the TFI measurements | The correlation between the clinician's measurements of Dry Eye and the corresponding Tear film imager reported parameters of interest will used to evaluate the association between the two assessments. | 1month |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the lipid layer thickness | Change from baseline of the lipid layer thickness as measured by the Tear film imager | from baseline to 1 month |
| Changes in the Macu-aqueous layer thickness |
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Inclusion Criteria:
Signed informed consent form.
Be at least 18 years of age at the time of enrollment of either sex or any race.
Best corrected visual acuity (BCVA) of 0.7 logMAR (ie, 20/100 vision) or better in each eye as measured using a Snellen chart
Intraocular pressure (IOP) in the range of 5 to 22 mmHg in both eyes.
DE subjects will be enrolled if they manifest symptoms (OSDI >=13) and signs of clinically active dry eye disease in either eye, by at least one of:
Control will be enrolled if they manifest NO symptoms (OSDI <13) and NO signs of clinically active dry eye disease in either eye, by meeting all the following criteria's:
A negative urine pregnancy test if female of childbearing potential.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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Blinding will take place at the reading center: the patient measurements will be unidentified. Adom's interpreter will not know to which group the examinee belonged to. After the conclusion of the study, the blindness will be removed, and a retrospective statistical analysis will be conducted.
Change from baseline of the Muco-aqueous layer thickness as measured by Tear film imager
| from baseline to 1 month |