NCT03479853

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

April 2, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

1.9 years

First QC Date

March 14, 2018

Last Update Submit

May 12, 2020

Conditions

Ocular RosaceaKeratoconjunctivitisMeibomian Gland Dysfunction

Keywords

Ocular RosaceaKeratoconjunctivitisMeibomian GlandInterferometryChild

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

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)

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)

Interventions

Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)PROCEDURE

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.

Cases : suffering from ocular or oculo-cutaneous rosaceaWitnesses

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Unable to achieve the meibographic and interferometric examination (Lipiview)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

RosaceaKeratoconjunctivitisMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesEyelid Diseases

Study Officials

  • Serge DOAN, MD

    Fondation Ophtalmologique A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 27, 2018

Study Start

April 2, 2018

Primary Completion

March 12, 2020

Study Completion

May 11, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Locations

FR(1)