Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa

Study Overview
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Brief Summary
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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)

Official Title
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Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa : Study of a Handheld in Vivo Confocal Microscope and of a Fluorescent in Vivo Confocal Microscope

Conditions
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Corneal Disease, Blepharitis, Lacrimal Apparatus Diseases

Intervention / Treatment
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* Device: Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml
* Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)
* Procedure: microangiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting with an ocular or ocular adnexa disease (infectious keratitis, stromal dystrophy, corneal surgery, ocular surface toxicity of eyedrops, cornea-conjunctival tumors, chronic blepharitis, eyelid tumors, diseases of the proximal lachrymal tract). For the microangiography: diabetic patients Exclusion Criteria: Allergy to one of the 3 dyes (fluorescein, indocyanine green, rose Bengal) Pregnancy and breast feeding Predicable impossible follow up For patient volunteer for intravenous injections: beta blockers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: an ocular or ocular adnexa disease<br>patient presenting with an ocular or ocular adnexa disease in the Dermatology or Ophthalmology ward. | Device: Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml<br>* used anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml<br>Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)<br>* used for Multifluorescence IVCM anesthesic eyedrop : oxybuprocaïne (1,6 mg/0,4 ml) Fluorescein 0,5%, Rose Bengal , Infracyanine<br>Procedure: microangiography<br>* realization of the microangiography with intravenous injection of fluoresceine and indocyanine green.<br>|
| Other: diabetic patients<br> | Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)<br>* used for Multifluorescence IVCM anesthesic eyedrop : oxybuprocaïne (1,6 mg/0,4 ml) Fluorescein 0,5%, Rose Bengal , Infracyanine<br>Procedure: microangiography<br>* realization of the microangiography with intravenous injection of fluoresceine and indocyanine green.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In vivo confocal microscopy, corneal disease, Blepharitis, Lacrimal Apparatus Diseases, Microscopy, Confocal