NCT02386774

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

March 21, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

4.5 years

First QC Date

February 20, 2015

Last Update Submit

January 4, 2024

Conditions

Corneal DiseaseBlepharitisLacrimal Apparatus Diseases

Keywords

In vivo confocal microscopycorneal diseaseBlepharitisLacrimal Apparatus DiseasesMicroscopy, Confocal

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (7)

  • 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

    1 year

  • handheld IVCM : determining the limits of the tumor

    1 year

  • +2 more secondary outcomes

Study Arms (2)

an ocular or ocular adnexa disease

OTHER

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 mlDevice: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)Procedure: microangiography

diabetic patients

OTHER
Device: Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)Procedure: microangiography

Interventions

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

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

an ocular or ocular adnexa disease
Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)DEVICE

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

an ocular or ocular adnexa diseasediabetic patients
microangiographyPROCEDURE

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

an ocular or ocular adnexa diseasediabetic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chu de Saint Etienne

Saint-Etienne, Dermatology, 42055, France

Location

Chu de Saint Etienne

Saint-Etienne, Ophtalmology, 42055, France

Location

MeSH Terms

Conditions

Corneal DiseasesBlepharitisLacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Eye DiseasesEyelid Diseases

Study Officials

  • Gilles THURET, MD PhD

    CHU de St Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2015

First Posted

March 12, 2015

Study Start

March 21, 2016

Primary Completion

September 28, 2020

Study Completion

September 28, 2020

Last Updated

January 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)