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

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Completed
• CT.gov ID: NCT03479853
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Actual Duration (Months): 25.3
• Patients Per Site Per Month: 4

Study Details

Study Description

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	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 102 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: Apr 2, 2018
• Actual Primary Completion Date: Mar 12, 2020
• Actual Study Completion Date: May 11, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Meibographic severity [Day of inclusion]

   The meibographic severity is determined by the level of Meibomian gland atrophy, data obtained with the Lipiview

3. Interferometric severity [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 [Day of inclusion]

   Number of abortive blinks during the Lipiview exam

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation Ophtalmologique A. de Rothschild	Paris		France	75019

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

• Principal Investigator: Serge DOAN, MD, Fondation Ophtalmologique A. de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT03479853
• Other Study ID Numbers: SDN_2017_26
• First Posted: Mar 27, 2018
• Last Update Posted: May 13, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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: Meibomian Gland Dysfunction; Keratitis; Keratoconjunctivitis; Rosacea

Study Results

No Results Posted as of May 13, 2020