Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-05 @ 1:12 AM
Study NCT ID:
NCT05385757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-04
First Post:
2020-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UNICORNS: Uveitis in Childhood Prospective National Cohort Study
Sponsor:
Institute of Child Health
Organization:
Study Overview
Official Title:
Uveitis in Childhood Prospective National Cohort Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UNICORNS
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: