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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00331-48 | Other Identifier | ANSM |
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In vivo confocal microscopy (IVCM) used in tertiary care ophthalmology centers is performed with two reflectance microscopes attached on a mounting with limited movement along the XYZ axes. Consequently, ocular diseases in the central area have been described (mostly cornea and adjacent conjunctiva). Two dermatology IVCM (an handheld small IVCM and a multifluorescent one) present significant innovations that the investigators want to assess in ophthalmology for the diagnosis of conjunctiva, cornea, eyelid and lachrymal tract diseases. The handheld IVCM have unlimited degrees of freedom and a small diameter objective. It could dramatically increase the area accessible to IVCM (whole conjunctiva, eyelids, proximal lachrymal tract) (part 1 of the present study). The fluorescent IVCM allows the use of a wide range of fluorescent markers liable to increase the specificity of the diagnosis by revealing staining patterns corresponding to a specific disease and not to others (part 2 of the study)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| an ocular or ocular adnexa disease | Other | patient presenting with an ocular or ocular adnexa disease in the Dermatology or Ophthalmology ward. |
|
| diabetic patients | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml | Device | used anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases | 1 year | |
| handheld IVCM : positive and negative predictive values in each 8 subgroups of diseases | 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles THURET, MD PhD | CHU de St Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Saint Etienne | Saint-Etienne | Dermatology | 42055 | France | ||
| Chu de Saint Etienne |
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| Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig) | Device | used for Multifluorescence IVCM
|
|
| microangiography | Procedure | realization of the microangiography with intravenous injection of fluoresceine and indocyanine green. |
|
| handheld IVCM : AUC of the ROC curve in each 8 subgroups of diseases |
| 1 year |
| handheld IVCM : factors influencing image quality | using a scale to 3 levels (2 : optic diagnosis ; 1 : presence of artifacts but possible optic diagnosis ; 0 :impossible optic diagnosis) | 1 year |
| handheld IVCM : determining the limits of the tumor | (in the particular case of tumors requiring surgery) | 1 year |
| fluorescence : staining patterns obtained for each disease group | 1 year |
| fluorescence : characteristics of the micro-angiography | characteristics of the conjunctival vessels in normal and diabetic patients | 1 year |
| Saint-Etienne |
| Ophtalmology |
| 42055 |
| France |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D001762 | Blepharitis |
| D007766 | Lacrimal Apparatus Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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