Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa

Blepharitis Clinical Trial

— INNOV-EYE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02386774
• Other study ID #: 1208180
• Secondary ID: 2015-A00331-48
• Status: Completed
• Phase: N/A
• Start date: March 21, 2016
• Est. completion date: September 28, 2020

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 28, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharitis
• Corneal Disease
• Corneal Diseases
• Lacrimal Apparatus Diseases

Intervention

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
• 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.

Locations

Country	Name	City	State
France	Chu de Saint Etienne	Saint Etienne	Dermatology
France	Chu de Saint Etienne	Saint Etienne	Ophtalmology

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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