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

• Conditions: Vernal Keratoconjunctivitis; Healthy Children
• Interventions: Procedure: Cytokins assay in tears

• Registration Number: NCT02057822
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-25
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-06
• Last Update Submitted: 2014-02-06
• Study First Posted: 2014-02-07
• Last Update Posted: 2014-02-07
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
vernal keratoconjunctivitis	Cytokins assay in tears	The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjonctivitis and in control subjects
healthy children	Cytokins assay in tears	The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France