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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Recruiting
CT.gov ID
NCT02386774
Collaborator
(none)
130
Enrollment
2
Locations
2
Arms
105.4
Anticipated Duration (Months)
65
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

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)

Condition or DiseaseIntervention/TreatmentPhase
  • 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
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Mar 21, 2016
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases [1 year]

Secondary Outcome Measures

  1. handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases [1 year]

  2. handheld IVCM : positive and negative predictive values in each 8 subgroups of diseases [1 year]

  3. handheld IVCM : AUC of the ROC curve in each 8 subgroups of diseases [1 year]

  4. 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)

  5. handheld IVCM : determining the limits of the tumor [1 year]

    (in the particular case of tumors requiring surgery)

  6. fluorescence : staining patterns obtained for each disease group [1 year]

  7. fluorescence : characteristics of the micro-angiography [1 year]

    characteristics of the conjunctival vessels in normal and diabetic patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Chu de Saint EtienneSaint EtienneDermatologyFrance42055
2Chu de Saint EtienneSaint EtienneOphtalmologyFrance42055

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Gilles THURET, MD PhD, CHU de St Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT02386774
Other Study ID Numbers:
  • 1208180
  • 2015-A00331-48
First Posted:
Mar 12, 2015
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022