An interventional study of Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml and Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig) in Corneal Disease, Blepharitis and Lacrimal Apparatus Diseases, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-08.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Diagnostic
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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This study's enrollment of 112 is above the median of 40 across 132 interventional studies indexed under Corneal Diseases.
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Exclusion Criteria:
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 · Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig) · Procedure: microangiography
Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig) · Procedure: microangiography
used anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml
used for Multifluorescence IVCM * anesthesic eyedrop : oxybuprocaïne (1,6 mg/0,4 ml) * Fluorescein 0,5%, Rose Bengal , Infracyanine
realization of the microangiography with intravenous injection of fluoresceine and indocyanine green.
Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases
Time frame: 1 year
handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases
Time frame: 1 year
handheld IVCM : positive and negative predictive values in each 8 subgroups of diseases
Time frame: 1 year
handheld IVCM : AUC of the ROC curve in each 8 subgroups of diseases
Time frame: 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)
Time frame: 1 year
handheld IVCM : determining the limits of the tumor
(in the particular case of tumors requiring surgery)
Time frame: 1 year
fluorescence : staining patterns obtained for each disease group
Time frame: 1 year
fluorescence : characteristics of the micro-angiography
characteristics of the conjunctival vessels in normal and diabetic patients
Time frame: 1 year
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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