UNICORNS: Uveitis in Childhood Prospective National Cohort Study
NCT ID: NCT05385757
Last Updated: 2024-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
250 participants
OBSERVATIONAL
2020-10-22
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Risk Factors for Therapeutic Failure in Chronic Non-Infectious Uveitis After First-Line Immunosuppressive Therapy
NCT06821971
Evaluation and Treatment of Patients With Inflammatory Eye Diseases
NCT00006188
The Cohort Study of Uveitis Patients
NCT05727540
Biomarkers in Ocular Inflammation and Uveitis
NCT04690829
Immune Responses to Antigens in Non-infectious Eye Inflammatory Diseases
NCT00357071
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Childhood Uveitis
Children \<18 years old newly diagnosed with non-infectious uveitis
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age \< 18years
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute for Health Research, United Kingdom
OTHER_GOV
Institute of Child Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ameenat L Solebo
Role: PRINCIPAL_INVESTIGATOR
University College London (UCL) Great Ormond Street Institute of Child Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
St Thomas' Hospital
London, , United Kingdom
Great Ormond Street Hospital NHS Foundation Trust
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, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Study Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
258638
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.