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Clinical Trial Summary

VKC is more common in males and tends to resolve with pubertal development. Clinical observation was not followed by an investigation that clarified whether there is a correlation between the hormonal pattern and the evolution of the disease, in particular it is not defined whether there is a correlation between the hormonal pattern and the resolution of the disease. This study aims to evaluate the hormonal pattern in patients with VKC and, in particular, the possible role of these hormones in the resolution of this condition in puberty.


Clinical Trial Description

The study presents a retrospective and prospective transversal observational design, non-pharmacological, monocentric, non-profit. It is based on the collection of clinical, laboratory and therapy data on databases of patients affected by Vernal keratoconjunctivitis. Participation in the study will be proposed to parents of patients with VKC over 10 years of age at puberty (B2 according to Tanner for females and G2 according to Tanner for males), based on endocrinological evaluation. Patients, differentiated by gender, will be divided into two groups: patients with active VKC and patients with resolved VKC. Both study groups will be offered a blood sample to determine the serum levels of LH, FSH, estradiol, DHEAS, androstenedione, total testosterone, SHBG, DHT, 17OH-progesterone, TSH-R, albumin, ACTH and cortisol. In postpuberal females, the sample must be taken in the first 5 days of the menstrual cycle. This study provides for the enrollment of patients diagnosed with VKC followed at the Allergy Outpatient Clinic of the UOSD Pediatrics High Intensity of Care - IRCCS Ca 'Granda Foundation Ospedale Maggiore Policlinico di Milano. The source documentation of the data will be the medical record and the reports of the examinations, provided for by the study, performed at the Institute. On the same day, a blood sample and a pubertal stage assessment will be performed. An allergy / ophthalmological examination for VKC will be carried out only if it had not been performed in the 12 months prior to the execution of the blood sample. There is no follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05038241
Study type Observational
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact
Status Recruiting
Phase
Start date April 1, 2021
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT00328653 - Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC) Phase 2/Phase 3
Recruiting NCT03186755 - Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis Phase 4