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

Primary Purpose

Corneal Disease, Blepharitis, Lacrimal Apparatus Diseases

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)

microangiography

About this trial

This is an interventional diagnostic trial for Corneal Disease focused on measuring In vivo confocal microscopy, corneal disease, Blepharitis, Lacrimal Apparatus Diseases, Microscopy, Confocal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chu de Saint EtienneRecruiting
Chu de Saint EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

an ocular or ocular adnexa disease

diabetic patients

Arm Description

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

Outcomes

Primary Outcome Measures

Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases

Secondary Outcome Measures

handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases

handheld IVCM : positive and negative predictive values in each 8 subgroups of diseases

handheld IVCM : AUC of the ROC curve in each 8 subgroups of diseases

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)

handheld IVCM : determining the limits of the tumor

(in the particular case of tumors requiring surgery)

fluorescence : staining patterns obtained for each disease group

fluorescence : characteristics of the micro-angiography

characteristics of the conjunctival vessels in normal and diabetic patients

Full Information

NCT ID

NCT02386774

First Posted

February 20, 2015

Last Updated

June 2, 2023

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

1. Study Identification

Unique Protocol Identification Number

NCT02386774

Brief Title

Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 21, 2016 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corneal Disease, Blepharitis, Lacrimal Apparatus Diseases

Keywords

In vivo confocal microscopy, corneal disease, Blepharitis, Lacrimal Apparatus Diseases, Microscopy, Confocal

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

an ocular or ocular adnexa disease

Arm Type

Other

Arm Description

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

Arm Title

diabetic patients

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

microangiography

Intervention Description

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

Primary Outcome Measure Information:

Title

Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases

Time Frame

1 year

Secondary Outcome Measure Information:

Title

handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases

Time Frame

1 year

Title

handheld IVCM : positive and negative predictive values in each 8 subgroups of diseases

Time Frame

1 year

Title

handheld IVCM : AUC of the ROC curve in each 8 subgroups of diseases

Time Frame

1 year

Title

handheld IVCM : factors influencing image quality

Description

using a scale to 3 levels (2 : optic diagnosis ; 1 : presence of artifacts but possible optic diagnosis ; 0 :impossible optic diagnosis)

Time Frame

1 year

Title

handheld IVCM : determining the limits of the tumor

Description

(in the particular case of tumors requiring surgery)

Time Frame

1 year

Title

fluorescence : staining patterns obtained for each disease group

Time Frame

1 year

Title

fluorescence : characteristics of the micro-angiography

Description

characteristics of the conjunctival vessels in normal and diabetic patients

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gilles THURET, MD PhD

Phone

04 77 12 75 40

Ext

+33

gilles.thuret@univ-st-etienne.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Carine LABRUYERE

Phone

04 77 12 04 69

Ext

+33

carine.labruyere@chu-st-etienne.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilles THURET, MD PhD

Organizational Affiliation

CHU de St Etienne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chu de Saint Etienne

City

Saint Etienne

State/Province

Dermatology

ZIP/Postal Code

42055

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean Luc PERROT, MD

First Name & Middle Initial & Last Name & Degree

Bruno LABEILLE, MD

First Name & Middle Initial & Last Name & Degree

Elisa CINOTTI, MD

First Name & Middle Initial & Last Name & Degree

Frederic CAMBAZARD, MD PhD

Facility Name

Chu de Saint Etienne

City

Saint Etienne

State/Province

Ophtalmology

ZIP/Postal Code

42055

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe GAIN, MD PhD

First Name & Middle Initial & Last Name & Degree

Damien GRIVET, MD

First Name & Middle Initial & Last Name & Degree

Gilles THURET, MD-PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa

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