RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age
ConditionUveitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-16
SponsorMeyer Children's Hospital IRCCS
About this trial
Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of non-infectious chronic uveitis before the age of 16;
signed informed consent form.
Disqualifiers
Patients with a diagnosis of infectious uveitis
history of malignant pathology,
history of demyelinating pathology,
history of cerebral vasculitis
Trial population
The data of patients who have been under the care of the hospital since 2010 will be included, and new patients diagnosed from the date of Ethical Committee approval onwards for the next 10 years will also be included
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Describe a population of paediatric patients with chronic non-infectious uveitis
* Frequency of each aetiology of uveitis * Frequency of signs and symptoms at onset of uveitis * Frequency of laboratory findings * Frequency of each anatomical subtype of uveitis
Time frame
thorugh the study and after 1 year2
Describe a population of paediatric patients with chronic non-infectious uveitis
* Frequency of complications at onset, 6 months, 12 months, 2 years, then every year * Frequency of impaired visual acuity (LogMAR0.4-1) and blindness (LogMAR\>=1) at onset and at different time points (6 months, 12 months, 18 months, 2 years, then every year)
Time frame
6 months, 12 months, 2 years and then every year3
Identify any differences between the different forms of uveitis in terms of characteristics and outcomes
* Frequency of complications and impaired visual acuity * Description of laboratory characteristics
Time frame
thorugh the study and after 1 year4
Identify risk factors for a more severe course
Percentages of children with impaired visual acuity * Percentages of children with ocular complications
Time frame
thorugh the study and after 1 yearSponsors and contacts
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Source ClinicalTrials.gov