HORMONES IN VERNAL KERATOCONJUNCTIVITIS (HOR-VKC-2020)

HORMONAL ROLE IN VERNAL KERATOCONJUNCTIVITIS

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.

Study Overview

• Status: Completed
• Conditions: Conjunctivitis, Vernal

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.

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20122
    • dr. Daniele Giovanni Ghiglioni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Active VKC; All females and males of pubertal age with active VKC undergo a blood sample for the determination of serum hormone levels, an allergological evaluation and an endocrinological evaluation. All is done at the time of enrollment.
Previous active VKC; All females and males of pubertal age who suffered of VKC undergo a blood sample for the determination of serum hormone levels, an allergological evaluation and an endocrinological evaluation. All is done at the time of enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	A venous blood sample is taken from all enrolled subjects for the determination of plasma testosterone. This collection is made in the morning, between 8.30 and 9.30 am.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	A venous blood sample is taken from all enrolled subjects for the determination of hormones. This collection is made in the morning, between 8.30 and 9.30 am.	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.
To assess the correlation between serum hormone levels and VKC activity.	A venous blood sample is taken from all enrolled subjects for the determination of plasma hormones. This collection is made in the morning, between 8.30 and 9.30 am. VKC activity is determined by an allergologic evaluation at the time of enrollment.	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.
To evaluate the possible presence of a serum hormone marker that may be related to the resolution of ocular symptoms.	A venous blood sample is taken from all enrolled subjects for the determination of plasma hormones. This collection is made in the morning, between 8.30 and 9.30 am. VKC activity is determined by an allergologic evaluation at the time of enrollment.	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.

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 29, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Keratitis; Corneal Diseases; Conjunctivitis; Conjunctivitis, Allergic; Keratoconjunctivitis
• Other Study ID Numbers: 1965

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No