Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-21

Study Completion Date

2020-09-28

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)

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Detailed Description

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Conditions

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Corneal Disease Blepharitis Lacrimal Apparatus Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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an ocular or ocular adnexa disease

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

Group Type OTHER

Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml

Intervention Type DEVICE

used anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml

Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)

Intervention Type DEVICE

used for Multifluorescence IVCM

* anesthesic eyedrop : oxybuprocaïne (1,6 mg/0,4 ml)
* Fluorescein 0,5%, Rose Bengal , Infracyanine

microangiography

Intervention Type PROCEDURE

realization of the microangiography with intravenous injection of fluoresceine and indocyanine green.

diabetic patients

Group Type OTHER

Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)

Intervention Type DEVICE

used for Multifluorescence IVCM

* anesthesic eyedrop : oxybuprocaïne (1,6 mg/0,4 ml)
* Fluorescein 0,5%, Rose Bengal , Infracyanine

microangiography

Intervention Type PROCEDURE

realization of the microangiography with intravenous injection of fluoresceine and indocyanine green.

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

microangiography

realization of the microangiography with intravenous injection of fluoresceine and indocyanine green.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No