Blepharitis, Corneal Disease, Lacrimal Apparatus Diseases
Conditions
Keywords
In vivo confocal microscopy, corneal disease, Blepharitis, Lacrimal Apparatus Diseases, Microscopy, Confocal
Brief summary
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)
Interventions
DEVICEHandheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml
used anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml
DEVICEMultifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)
used for Multifluorescence IVCM * anesthesic eyedrop : oxybuprocaïne (1,6 mg/0,4 ml) * Fluorescein 0,5%, Rose Bengal , Infracyanine
PROCEDUREmicroangiography
realization of the microangiography with intravenous injection of fluoresceine and indocyanine green.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year | using a scale to 3 levels (2 : optic diagnosis ; 1 : presence of artifacts but possible optic diagnosis ; 0 :impossible optic diagnosis) |
| handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases | 1 year | — |
| fluorescence : staining patterns obtained for each disease group | 1 year | — |
| fluorescence : characteristics of the micro-angiography | 1 year | characteristics of the conjunctival vessels in normal and diabetic patients |
| handheld IVCM : determining the limits of the tumor | 1 year | (in the particular case of tumors requiring surgery) |
Countries
France
Outcome results
None listed