HORMONES IN VERNAL KERATOCONJUNCTIVITIS

NCT05038241 | Completed

• 1 other identifier: 1965
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Conjunctivitis, Vernal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  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.

  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.

  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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

dr. Daniele Giovanni Ghiglioni

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 9, 2021
• Study Start: April 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 22, 2022

Record last verified: 2021-08

Locations

IT (1)