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Clinical Trials/NCT02386774
NCT02386774
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country112 target enrollmentMarch 21, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Corneal Disease
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
112
Locations
1
Primary Endpoint
Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases
Status
Completed
Last Updated
2 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
March 21, 2016
End Date
September 28, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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

Outcomes

Primary Outcomes

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

Time Frame: 1 year

Secondary Outcomes

  • fluorescence : characteristics of the micro-angiography(1 year)
  • 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 : determining the limits of the tumor(1 year)
  • fluorescence : staining patterns obtained for each disease group(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)

Study Sites (1)

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