HORMONES IN VERNAL KERATOCONJUNCTIVITIS
Condition: Conjunctivitis, Vernal
MeSH terms: Conjunctivitis; Keratoconjunctivitis; Conjunctivitis, Allergic
Study type: Observational

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.
    

Detailed 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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study involves the enrollment of 2 groups of subjects: pubertal patients with active
        VKC and pubertal / postpuberal patients who have suffered from VKC in the past years, but
        no longer in 2021. To all the subjects under examination, both males both females, a blood
        sample is performed for the determination of hormonal levels, an allergological /
        ophthalmological evaluation to determine the phase of activity of the VKC and an
        endocrinological evaluation to determine the degree of pubertal development.