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

Completed

• Conditions: Keratoconjunctivitis; Meibomian Gland Dysfunction; Ocular Rosacea
• Interventions: Procedure: Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)

• Registration Number: NCT03479853
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-03-27
• Study Start: 2018-04-02
• Primary Completion: 2020-03-12
• Status Verified: 2020-05
• Study Completion: 2020-05-11
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases : suffering from ocular or oculo-cutaneous rosacea	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.
Witnesses	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.

Primary Outcome Measures

Name	Time	Method
Clinical severity	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	Day of inclusion	The meibographic severity is determined by the level of Meibomian gland atrophy, data obtained with the Lipiview
Number of abortive blinks	Day of inclusion	Number of abortive blinks during the Lipiview exam
Interferometric severity	Day of inclusion	The interferometric severity is evaluated by the thickness of the lipid layer tear film, data obtained with the Lipiview

Trial Locations

Locations (1)

Fondation Ophtalmologique A. de Rothschild; 🇫🇷 Paris, France