Clinical trial NCT05385757: UNICORNS: Uveitis in Childhood Prospective National Cohort Study
Official title: Uveitis in Childhood Prospective National Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Uveitis
Keywords: Quality of life
Child
Prospective Cohort
Vision
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2022-05-23
Enrollment: 250
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children those aged under 18 years old (at diagnosis) who are newly diagnosed with uveitis newly diagnosed with uveitis (within previous 6 months)

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of ocular complications
timeFrame: Up to 3 years
measure: Pediatric Quality of Life Inventory Score
timeFrame: Up to 3 years
Secondary outcomes:
measure: Corticosteroid exposure
timeFrame: Up to 3 years
measure: Attainment of disease control
timeFrame: Up to 3 years
measure: Health Utility
timeFrame: Up to 3 years
measure: Change in Pediatric Quality of Life Inventory Score
timeFrame: Over one year from baseline to year one
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast Royal Victoria Hospital NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: Birmingham Women's and Children's Hospital NHS Foundation Trust
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Christchurch Hospitals NHS Foundation Trust
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board Hospitals
city: Chelmsford
country: United Kingdom
facility: Mid Essex Hospital Trust
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Edinburgh
country: United Kingdom
facility: Princess Alexandra Eye Pavilion
city: Glasgow
country: United Kingdom
facility: Royal Children's Hospital
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospitals NHS Foundation Trust
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: Alder Hey Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: St Thomas' Hospital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital NHS Foundation Trust
city: Maidstone
country: United Kingdom
facility: Maidstone and Tunbridge Wells NHS Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Redhill
country: United Kingdom
facility: Sussex Eye Hospital and Royal Alexandra Children's Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Westcliff-on-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
city: Whitechapel
country: United Kingdom
facility: Royal London Hospital
city: York
country: United Kingdom
facility: York Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: University College London (UCL) Great Ormond Street Institute of Child Health
name: Ameenat L Solebo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kellett S, Rahi JS, Dick AD, Knowles R, Tadic V, Solebo AL. UNICORNS: Uveitis in childhood prospective national cohort study protocol. F1000Res. 2023 Aug 30;9:1196. doi: 10.12688/f1000research.26689.2. eCollection 2020.