Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa

Not Applicable

Completed

• Conditions: Lacrimal Apparatus Diseases; Corneal Disease; Blepharitis
• Interventions: Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig); Procedure: microangiography

• Registration Number: NCT02386774
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-12
• Study Start: 2016-03-21
• Primary Completion: 2020-09-28
• Study Completion: 2020-09-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
diabetic patients	microangiography	-
an ocular or ocular adnexa disease	Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)	patient presenting with an ocular or ocular adnexa disease in the Dermatology or Ophthalmology ward.
diabetic patients	Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)	-
an ocular or ocular adnexa disease	microangiography	patient presenting with an ocular or ocular adnexa disease in the Dermatology or Ophthalmology ward.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases	1 year

Secondary Outcome Measures

Name	Time	Method
fluorescence : characteristics of the micro-angiography	1 year	characteristics of the conjunctival vessels in normal and diabetic patients
handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases	1 year
handheld IVCM : positive and negative predictive values in each 8 subgroups of diseases	1 year
handheld IVCM : determining the limits of the tumor	1 year	(in the particular case of tumors requiring surgery)
fluorescence : staining patterns obtained for each disease group	1 year
handheld IVCM : AUC of the ROC curve in each 8 subgroups of diseases	1 year
handheld IVCM : factors influencing image quality	1 year	using a scale to 3 levels (2 : optic diagnosis ; 1 : presence of artifacts but possible optic diagnosis ; 0 :impossible optic diagnosis)

Trial Locations

Locations (1)

Chu de Saint Etienne; 🇫🇷 Saint Etienne, Ophtalmology, France