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

Meibomian Gland Dysfunction Clinical Trial

— MEIBO-ROSACEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479853
• Other study ID #: SDN_2017_26
• Status: Completed
• Start date: April 2, 2018
• Est. completion date: May 11, 2020

Study information

• Verified date: May 2020
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 11, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Keratitis
• Keratoconjunctivitis
• Meibomian Gland Dysfunction
• Ocular Rosacea
• Rosacea

Intervention

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.

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

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