Trials / Completed
CompletedNCT02386774
Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Handheld 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 |
| DEVICE | Multifluorescence 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 |
| PROCEDURE | microangiography | realization of the microangiography with intravenous injection of fluoresceine and indocyanine green. |
Timeline
- Start date
- 2016-03-21
- Primary completion
- 2020-09-28
- Completion
- 2020-09-28
- First posted
- 2015-03-12
- Last updated
- 2024-01-08
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02386774. Inclusion in this directory is not an endorsement.