Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa (INNOV-EYE)

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

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)

Study Overview

• Status: Completed
• Conditions: Lacrimal Apparatus Diseases; Blepharitis; Corneal Disease
• Intervention / Treatment: Device: Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml; Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig); Procedure: microangiography

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dermatology
    • Saint Etienne, Dermatology, France, 42055
      • Chu de Saint Etienne
  • Ophtalmology
    • Saint Etienne, Ophtalmology, France, 42055
      • Chu de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: an ocular or ocular adnexa disease; patient presenting with an ocular or ocular adnexa disease in the Dermatology or Ophthalmology ward.	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.
Other: diabetic patients	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 : AUC of the ROC curve in each 8 subgroups of diseases		1 year
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
handheld IVCM : determining the limits of the tumor	(in the particular case of tumors requiring surgery)	1 year
fluorescence : staining patterns obtained for each disease group		1 year
fluorescence : characteristics of the micro-angiography	characteristics of the conjunctival vessels in normal and diabetic patients	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Gilles THURET, MD PhD, CHU de St Etienne

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2016
• Primary Completion (Actual): September 28, 2020
• Study Completion (Actual): September 28, 2020

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: March 6, 2015
• First Posted (Estimated): March 12, 2015

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Blepharitis; Lacrimal Apparatus Diseases; Microscopy, Confocal; In vivo confocal microscopy; corneal disease
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Lacrimal Apparatus Diseases; Corneal Diseases; Blepharitis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ophthalmic Solutions; Benoxinate
• Other Study ID Numbers: 1208180; 2015-A00331-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO