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Completed

NCT Number: NCT03479853

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

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

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Key information

Conditions

Ocular Rosacea Conjunctival Diseases Conjunctivitis Corneal Diseases Eye Diseases Eyelid Diseases Keratitis Keratoconjunctivitis Meibomian Gland Dysfunction Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)

Procedure

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.

Primary outcomes

  1. 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.

  2. Meibographic severity

    Time frame: Day of inclusion

    The meibographic severity is determined by the level of Meibomian gland atrophy, data obtained with the Lipiview

  3. 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

  4. Number of abortive blinks

    Time frame: Day of inclusion

    Number of abortive blinks during the Lipiview exam

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: MEIBO-ROSACEE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 27, 2018
Registry last updated
May 13, 2020

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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