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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03479853
Acronym
MEIBO-ROSACEE
Enrollment
102
Registered
2018-03-27
Start date
2018-04-02
Completion date
2020-05-11
Last updated
2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconjunctivitis, Meibomian Gland Dysfunction, Ocular Rosacea

Keywords

Ocular Rosacea, Keratoconjunctivitis, Meibomian Gland, Interferometry, Child

Brief summary

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

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

PROCEDUREOphthalmologic 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.

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of abortive blinksDay of inclusionNumber of abortive blinks during the Lipiview exam
Clinical severityDay of inclusionClinical 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 severityDay of inclusionThe meibographic severity is determined by the level of Meibomian gland atrophy, data obtained with the Lipiview
Interferometric severityDay of inclusionThe interferometric severity is evaluated by the thickness of the lipid layer tear film, data obtained with the Lipiview

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026