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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00139-30 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Laboratoire Biologie, Ingénierie et Imagerie de la Greffe de Cornée (BiiGC) | UNKNOWN |
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In order to develop innovative biomarkers for the diagnosis of two ocular surface pathologies, Dry Syndrome (DS) and Limbic Stem Cell Deficiency (LSCD), human cells from the ocular surface will be collected in order to test these biomarkers ex vivo.
To collect them, cytological fingerprints of the ocular surface are made using filter paper applied to the surface using a commercially available EC (European Conformity)-marked medical device, called EYEPRIM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | 150 patients with eye diseases other than dry eye syndrome or limbal stem cell deficiency will be included. |
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| dry eye syndrome | 100 patients with dry eye syndrome will be included. |
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| limbal stem cell deficiency | 50 patients with limbal stem cell deficiency will be included. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EYEPRIM | Diagnostic Test | Collection of conjunctival impressions using the EC(European Conformity )-marked EYEPRIM device . This device enables cells to be collected the superficial ocular surface cells by applying a membrane for few seconds to the ocular surface. |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular surface impression cytology collected from patients suffering from dry eye syndrome, limbal stem cell deficiency or other pathologies (control). | Collection of cells from the ocular surface by performing a cytological imprint of the ocular surface | day one |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles THURET, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Etienne | Saint-Etienne | France |
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| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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