Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa (INNOV-EYE)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Blepharitis; Lacrimal Apparatus Diseases; Corneal Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02386774

2015-A00331-48 (Other Identifier)

1208180

Details and patient eligibility

About

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)

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

an ocular or ocular adnexa disease

Other group

Description:

patient presenting with an ocular or ocular adnexa disease in the Dermatology or Ophthalmology ward.

Treatment:

Procedure: microangiography

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)

diabetic patients

Other group

Treatment:

Procedure: microangiography

Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)