Clinical, Meibographic and Interferometric Evaluation of Phlyctenular Keratitis in Children – MEIBO-ROSACEE

Overview

The aim of this study is to describe the clinical, meibographic and interferometric manifestations of phlyctenular keratitis in children.

Full Title of Study: “Clinical, Meibographic and Interferometric Evaluation of Phlyctenular Keratitis in Children – MEIBO-ROSACEE”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 12, 2020

Detailed Description

The investigators are conducting a monocentric, transversal, epidemiologic study. 100 patients should be included: 50 children suffering from ocular rosacea, and 50 children with no palpebral or Meibomian disease. Witnesses will be matched on the age of the cases. Patient and controls will undergo a classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, the child will go through a meibographic and interferometric evaluation of his two inferior eyelids. This evaluation is made by an optometrist with the Lipiview device, and lasts a few minutes.

Interventions

  • Procedure: Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)
    • Classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, meibographic and interferometric evaluation of his two inferior eyelids with the Lipiview device.

Arms, Groups and Cohorts

  • Cases : suffering from ocular or oculo-cutaneous rosacea
    • Classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, meibographic and interferometric evaluation of his two inferior eyelids with the Lipiview device.
  • Witnesses
    • Without any present or past palpebral meibomian Gland Dysfunction Classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, meibographic and interferometric evaluation of his two inferior eyelids with the Lipiview device.

Clinical Trial Outcome Measures

Primary Measures

  • Clinical severity
    • Time Frame: Day of inclusion
    • Clinical severity is determined with a composite score, by the presence of chalazia, corneal lesions, neovascularization, phlyctena, loss of vision, superficial keratitis, anterior and posterior keratitis, meibomitis, palpebral margin keratinization, lagophthalmos, long term use of azithromycin treatment, treatment by ciclosporin eyedrops, intense cutaneous or ocular symptoms, long time evolution of the disease.
  • Meibographic severity
    • Time Frame: Day of inclusion
    • The meibographic severity is determined by the level of Meibomian gland atrophy, data obtained with the Lipiview
  • Interferometric severity
    • Time Frame: Day of inclusion
    • The interferometric severity is evaluated by the thickness of the lipid layer tear film, data obtained with the Lipiview
  • Number of abortive blinks
    • Time Frame: Day of inclusion
    • Number of abortive blinks during the Lipiview exam

Participating in This Clinical Trial

Inclusion Criteria

  • Recruited from a specialized ophthalmologic consultation Rothschild Ophthalmologic Foundation, Paris, France. – Cases : suffering from ocular or oculo-cutaneous rosacea – Witnesses : without any present or past palpebral or meibomian disease Exclusion Criteria:

  • Unable to achieve the meibographic and interferometric examination (Lipiview)

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondation Ophtalmologique Adolphe de Rothschild
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Serge DOAN, MD, Principal Investigator, Fondation Ophtalmologique A. de Rothschild

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.