Clinical trial NCT05038241: HORMONES IN VERNAL KERATOCONJUNCTIVITIS
Official title: HORMONAL ROLE IN VERNAL KERATOCONJUNCTIVITIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conjunctivitis, Vernal
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 88
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of VKC assessed by an allergologist or ophthalmologist over 10 years of age

Exclusion Criteria:

* Presence of pre-existing pathologies of the endocrine system.

Primary outcomes:
measure: To assess the difference in serum total testosterone levels between the population of subjects with active VKC and the population of subjects with resolved VKC.
timeFrame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for the determination of plasma testosterone. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
Secondary outcomes:
measure: To evaluate the difference in serum levels of the other hormones investigated between the population of subjects with active VKC and the population of subjects with resolved VKC.
timeFrame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for the determination of plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
measure: To assess the correlation between serum hormone levels and VKC activity.
timeFrame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
measure: To evaluate the possible presence of a serum hormone marker that may be related to the resolution of ocular symptoms.
timeFrame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
Other outcomes:
Locations:
city: Milano
country: Italy
facility: dr. Daniele Giovanni Ghiglioni
Study officials:
References: