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

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

Study Overview

• Status: Completed
• Conditions: Keratoconjunctivitis; Meibomian Gland Dysfunction; Ocular Rosacea
• Intervention / Treatment: Procedure: Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)

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 Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation Ophtalmologique A. De Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day of inclusion
Meibographic severity	The meibographic severity is determined by the level of Meibomian gland atrophy, data obtained with the Lipiview	Day of inclusion
Interferometric severity	The interferometric severity is evaluated by the thickness of the lipid layer tear film, data obtained with the Lipiview	Day of inclusion
Number of abortive blinks	Number of abortive blinks during the Lipiview exam	Day of inclusion

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Serge DOAN, MD, Fondation Ophtalmologique A. De Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): May 11, 2020

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Child; Keratoconjunctivitis; Meibomian Gland; Ocular Rosacea; Interferometry
• Additional Relevant MeSH Terms: Skin Diseases; Eye Diseases; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Eyelid Diseases; Rosacea; Keratitis; Meibomian Gland Dysfunction; Keratoconjunctivitis
• Other Study ID Numbers: SDN_2017_26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No