Clinical Trial: Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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)

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Current Primary Outcome: Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases [ Time Frame: 1 year ]
  • handheld IVCM : positive and negative predictive values in each 8 subgroups of diseases [ Time Frame: 1 year ]
  • handheld IVCM : AUC of the ROC curve in each 8 subgroups of diseases [ Time Frame: 1 year ]
  • 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)
  • handheld IVCM : determining the limits of the tumor [ Time Frame: 1 year ]
    (in the particular case of tumors requiring surgery)
  • fluorescence : staining patterns obtained for each disease group [ Time Frame: 1 year ]
  • fluorescence : characteristics of the micro-angiography [ Time Frame: 1 year ]
    characteristics of the conjunctival vessels in normal and diabetic patients


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Saint Etienne

Dates:
Date Received: February 20, 2015
Date Started: March 2016
Date Completion: February 2019
Last Updated: April 7, 2017
Last Verified: October 2016