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Completed

NCT Number: NCT02386774

Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Saint Etienne, Saint-Etienne, Dermatology, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

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

microangiography

Procedure

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

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

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

    Time frame: 1 year

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

    Time frame: 1 year

  4. handheld IVCM : factors influencing image quality

    Time frame: 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

    Time frame: 1 year

    (in the particular case of tumors requiring surgery)

  6. fluorescence : staining patterns obtained for each disease group

    Time frame: 1 year

  7. fluorescence : characteristics of the micro-angiography

    Time frame: 1 year

    characteristics of the conjunctival vessels in normal and diabetic patients

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Acronym: INNOV-EYE

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2015
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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