An observational study in Ocular Rosacea, Keratoconjunctivitis and Meibomian Gland Dysfunction, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 1 site in France. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-05-13.
Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational
The aim of this study is to describe the clinical, meibographic and interferometric manifestations of phlyctenular keratitis in children.
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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 102 is below the median of 265 across 23 observational studies indexed under Rosacea.
Browse Rosacea studies →Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.
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Children aged between 2 and 16 : Cases, suffering from ocular or oculo-cutaneous rosacea and Witnesses without any present or past palpebral or meibomian disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Procedure: Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)
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.
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.
Clinical severity
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.
Time frame: Day of inclusion
Meibographic severity
The meibographic severity is determined by the level of Meibomian gland atrophy, data obtained with the Lipiview
Time frame: Day of inclusion
Interferometric severity
The interferometric severity is evaluated by the thickness of the lipid layer tear film, data obtained with the Lipiview
Time frame: Day of inclusion
Number of abortive blinks
Number of abortive blinks during the Lipiview exam
Time frame: Day of inclusion
Plan to share: Undecided
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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