Clinical trial NCT02386774: Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Disease
Blepharitis
Lacrimal Apparatus Diseases
Keywords: In vivo confocal microscopy
corneal disease
Blepharitis
Lacrimal Apparatus Diseases
Microscopy, Confocal
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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)


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases
timeFrame: 1 year
Secondary outcomes:
measure: handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases
timeFrame: 1 year
measure: handheld IVCM : positive and negative predictive values in each 8 subgroups of diseases
timeFrame: 1 year
measure: handheld IVCM : AUC of the ROC curve in each 8 subgroups of diseases
timeFrame: 1 year
measure: handheld IVCM : factors influencing image quality
timeFrame: 1 year
measure: handheld IVCM : determining the limits of the tumor
timeFrame: 1 year
measure: fluorescence : staining patterns obtained for each disease group
timeFrame: 1 year
measure: fluorescence : characteristics of the micro-angiography
timeFrame: 1 year
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
state: Dermatology
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
state: Ophtalmology
Study officials:
affiliation: CHU de St Etienne
name: Gilles THURET, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: