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

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ClinicalTrials.gov Identifier: NCT03479853
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Ocular Rosacea Keratoconjunctivitis Meibomian Gland Dysfunction 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
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical, Meibographic and Interferometric Evaluation of Phlyctenular Keratitis in Children - MEIBO-ROSACEE
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Clinical severity [ Time Frame: 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.

  2. Meibographic severity [ Time Frame: Day of inclusion ]
    The meibographic severity is determined by the level of Meibomian gland atrophy, data obtained with the Lipiview

  3. Interferometric severity [ Time Frame: Day of inclusion ]
    The interferometric severity is evaluated by the thickness of the lipid layer tear film, data obtained with the Lipiview

  4. Number of abortive blinks [ Time Frame: Day of inclusion ]
    Number of abortive blinks during the Lipiview exam



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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479853


Contacts
Contact: Laurence SALOMON, MD 0148036431 ext +33 lsalomon@for.paris

Locations
France
Fondation Ophtalmologique A. de Rothschild Recruiting
Paris, France, 75019
Contact: Serge DOAN, MD       serge.doan@gmail.com   
Contact: Tiphanie AUDELAN       tiphanie.audelan@gmail.com   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Serge DOAN, MD Fondation Ophtalmologique A. de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03479853     History of Changes
Other Study ID Numbers: SDN_2017_26
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Ocular Rosacea
Keratoconjunctivitis
Meibomian Gland
Interferometry
Child

Additional relevant MeSH terms:
Rosacea
Keratoconjunctivitis
Keratitis
Skin Diseases
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases