Cytokine Assay in Tears of Healthy Children and With Vernal Keratoconjunctivitis: Case Control Study and Monitoring of Cases at 6 Months

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT02057822

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The ocular surface may be the seat of an inflammatory process in many pathology as vernal keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells themselves and the constituent cells of the target organ, are the main factors that cause inflammation. The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.

Condition or Disease	Intervention/Treatment	Phase
Vernal Keratoconjunctivitis Healthy Children	Procedure: Cytokins assay in tears

Detailed Description

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Time Perspective:

Prospective

Official Title:

Cytokine Assay in Tears of Healthy Children and With Vernal Keratocunjonctivitis: Case Control Study and Monitoring of Cases at 6 Months

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
vernal keratoconjunctivitis The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjonctivitis and in control subjects	Procedure: Cytokins assay in tears
healthy children The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects	Procedure: Cytokins assay in tears

Arm

Intervention/Treatment

vernal keratoconjunctivitis

The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjonctivitis and in control subjects

Procedure: Cytokins assay in tears

healthy children

The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects

Procedure: Cytokins assay in tears

Outcome Measures

Primary Outcome Measures

Concentration of 40 cytokines in tears [at time 0]
Comparaison of concentration of 40 cytokines in tears between healthy children and children with vernal keratoconjunctivitis

Secondary Outcome Measures

Validation of normal range of cytokines in tears of healthy children [at 6 month]
Modification of the inflammatory profile according to the clinical severity and treatment [at 6 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Childrens between 3 and 18 years
Affiliated at system of French social security
Signed by the holders of parental authority of the sheet and written consent to participate in this study
First consultation at Clermont-Ferrand Hospital for vernal keratocunjunctivitis

Exclusion Criteria:

Subject suffering from acute or chronic eye disease in which the physician investigator resound with the results: uveitis, glaucoma, retinopathy
Subject who had undergone eye surgery
Subject having an infection the day of collection: ENT, digestive, urinary
Subject with cancer, mental illness or any other condition in which the physician investigator sound informed consent and / or the results
Pregnant subject
Subject with contact lenses
Subject who judged by the investigating physician not enough cooperating to allow a safe collection