UNICORNS: Uveitis in Childhood Prospective National Cohort Study

Uveitis Clinical Trial

— UNICORNS  

Official title:

Uveitis in Childhood Prospective National Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05385757
• Other study ID #: 258638
• Status: Active, not recruiting
• Start date: October 22, 2020
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Childhood uveitis (inflammation inside the eye) is an uncommon disorder that carries the risk of blindness. Inadequate treatment of active inflammation has been shown to be related to a poor outcome. There has been no population-based, prospective longitudinal study of all-cause childhood uveitis, with resultant limitations in the evidence base used to counsel affected families, balance treatment decisions, or plan further research. The aim of the study is to describe the characteristics of childhood-onset uveitis and describe outcomes. The investigators shall also aim to identify the socio-demographic, clinical, biological and treatment-related determinants of outcome. Early (1-2 years following diagnosis) outcomes will be described in the first instance: However, through the creation of a national inception cohort, the investigators shall enable longer-term studies of outcome for affected children and families. There will be no change to routine clinical care.

Description:

Background:

Childhood uveitis descriptive term for a group of rare inflammatory eye disease, which are typically chronic, relapsing-remitting in nature, and of uncertain aetiology (idiopathic). Visual loss occurs due to structural damage caused by uncontrolled inflammation. Understanding of the determinants of long-term outcome is limited, particularly the predictors of therapeutic response or how to define disease control.

Aims:

To describe disease natural history and outcomes amongst a nationally representative group of children with non-infectious uveitis, describe the impact of disease course on quality of life for both child and family, and identify determinants of adverse visual, structural and developmental outcomes.

Methods:

UNICORNS is a prospective longitudinal multicentre cohort study of children newly diagnosed with uveitis about whom a core minimum clinical dataset will be collected. Participants and their families will also complete patient-reported outcome measures (PROMS) at study entry and annually from recruitment.

PROMS collected at baseline are:

• Strength and Difficulties Questionnaire (SDQ): this is to screen the emotional and behavioural aspects of the participants' lives

• Child Health Utility 9D (CHU9D): generic preference based measure of health related quality of life

• Children's Sleep Habits Questionnaire (CHSQ): this evaluates incidence of behaviours linked with typical paediatric sleep difficulties

• 100-mm General Evaluation (GE): visual analogue score 100mm long used to capture overall perception of the burden of disease

PROMS collected at year 1 and annually (subject to investigations of instrument redundancy) are:

• Child Health Utility 9D (CHU9D): generic preference based measure of health related quality of life

• 100-mm General Evaluation (GE): visual analogue score 100mm long used to capture overall perception of the burden of disease

• Paediatric Quality of life Score (PedsQL): a brief questionnaire used to evaluate health related quality of life in children

• Vision related quality of life metric - Children and Young People (VQoL_CYP): these instruments captures the functional and broader impacts of living with a visual disability The association of patient (child- and treatment- dependent) characteristics with outcome will be investigated using logistic and ordinal regression models which incorporate adjustment for within-child correspondence between eyes for those with bilateral disease and repeated outcomes measurement.

Discussion:

Through this population based, prospective longitudinal study of childhood uveitis, the investigators will describe the characteristics of childhood onset disease. Early (1-2 years following diagnosis) outcomes will be described in the first instance, and through the creation of a national inception cohort, longer term studies of outcome for affected children and families will be enabled.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Children newly diagnosed with uveitis (within previous 6 months)

• Age < 18years

Exclusion Criteria:

• Uveitis due to malignancy

• Uveitis due to ocular trauma (including iatrogenic, ie intraocular surgery)

• Uveitis due to confirmed ocular infection

• Children with developmental disorders or impairments which prevent their self-report of their function level or quality of life

Related Conditions & MeSH terms

• Uveitis

Locations

Country	Name	City	State
United Kingdom	Belfast Royal Victoria Hospital NHS Foundation Trust	Belfast
United Kingdom	Birmingham Women's and Children's Hospital NHS Foundation Trust	Birmingham
United Kingdom	Royal Bournemouth Christchurch Hospitals NHS Foundation Trust	Bournemouth
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust	Bradford
United Kingdom	University Hospitals Bristol NHS Foundation Trust	Bristol
United Kingdom	Cambridge University Hospital NHS Foundation Trust	Cambridge
United Kingdom	Cardiff and Vale University Health Board Hospitals	Cardiff
United Kingdom	Mid Essex Hospital Trust	Chelmsford
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Princess Alexandra Eye Pavilion	Edinburgh
United Kingdom	Royal Children's Hospital	Glasgow
United Kingdom	James Paget University Hospitals NHS Foundation Trust	Great Yarmouth
United Kingdom	Hull University Teaching Hospitals NHS Trust	Hull
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Alder Hey Hospital NHS Foundation Trust	Liverpool
United Kingdom	Great Ormond Street Hospital NHS Foundation Trust	London
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	St Thomas' Hospital	London
United Kingdom	Maidstone and Tunbridge Wells NHS Trust	Maidstone
United Kingdom	Manchester University NHS Foundation Trust	Manchester
United Kingdom	Newcastle Upon Tyne Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	Sussex Eye Hospital and Royal Alexandra Children's Hospital	Redhill
United Kingdom	Sheffield Children's Hospitals NHS Foundation Trust	Sheffield
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-on-Sea
United Kingdom	Royal London Hospital	Whitechapel
United Kingdom	York Teaching Hospital NHS Foundation Trust	York

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Child Health	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Kellett S, Rahi JS, Dick AD et al. UNICORNS: Uveitis in childhood prospective national cohort study protocol [version 1; peer review: awaiting peer review]. F1000Research 2020, 9:1196 (https://doi.org/10.12688/f1000research.26689.1)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ocular complications	New incident of sight threatening ocular complications, including glaucoma, cataract and macular oedema	Up to 3 years
Primary	Pediatric Quality of Life Inventory Score	Quality of life (patient reported outcomes) using Pediatric Quality of Life Inventory (PedsQL) in which items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life)	Up to 3 years
Secondary	Corticosteroid exposure	Total prescribed topical and systemic corticosteroid burden	Up to 3 years
Secondary	Attainment of disease control	Number of children achieving absolute control defined as absence of inflammation Relative control defined as the absence of inflammation greater than 0.5 The lowest grade of inflammation, with the use of less than one drop of topical corticosteroid	Up to 3 years
Secondary	Health Utility	Child Health Utility Metric (CHU9D), with scores ranging from 0.33 (worst health state) to 1.00 (best health state)	Up to 3 years
Secondary	Change in Pediatric Quality of Life Inventory Score	Change in child reported quality of life using Pediatric Quality of Life Inventory (PedsQL) in which items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life), and a change of greater than 5 is clinically meaningful	Over one year from baseline to year one

External Links

•   Study Video
•   Study Website