UNICORNS: Uveitis in Childhood Prospective National Cohort Study

• Sponsor: Institute of Child Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05385757
• Collaborator: National Institute for Health Research, United Kingdom (Other)
• Enrollment: 250
• Locations: 31
• Anticipated Duration (Months): 41.3
• Patients Per Site: 8.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Uveitis in Childhood Prospective National Cohort Study
• Actual Study Start Date: Oct 22, 2020
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Childhood Uveitis Children <18 years old newly diagnosed with non-infectious uveitis

Outcome Measures

Primary Outcome Measures

1. Incidence of ocular complications [Up to 3 years]

   New incident of sight threatening ocular complications, including glaucoma, cataract and macular oedema

2. Pediatric Quality of Life Inventory Score [Up to 3 years]

   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)

Secondary Outcome Measures

1. Corticosteroid exposure [Up to 3 years]

   Total prescribed topical and systemic corticosteroid burden

2. Attainment of disease control [Up to 3 years]

   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

3. Health Utility [Up to 3 years]

   Child Health Utility Metric (CHU9D), with scores ranging from 0.33 (worst health state) to 1.00 (best health state)

4. Change in Pediatric Quality of Life Inventory Score [Over one year from baseline to year one]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Belfast Royal Victoria Hospital NHS Foundation Trust	Belfast		United Kingdom	BT9 7AB
2	Birmingham Women's and Children's Hospital NHS Foundation Trust	Birmingham		United Kingdom	B4 6NH
3	Royal Bournemouth Christchurch Hospitals NHS Foundation Trust	Bournemouth		United Kingdom	BH7 7DW
4	Bradford Teaching Hospitals NHS Foundation Trust	Bradford		United Kingdom	BD9 6RJ
5	University Hospitals Bristol NHS Foundation Trust	Bristol		United Kingdom	BS1 3NU
6	Cambridge University Hospital NHS Foundation Trust	Cambridge		United Kingdom	CB2 0QQ
7	Cardiff and Vale University Health Board Hospitals	Cardiff		United Kingdom	CF14 4XW
8	Mid Essex Hospital Trust	Chelmsford		United Kingdom	CM1 7ET
9	Ninewells Hospital	Dundee		United Kingdom	DD1 9SY
10	Princess Alexandra Eye Pavilion	Edinburgh		United Kingdom	EH1 3EG
11	Royal Children's Hospital	Glasgow		United Kingdom	G51 4TF
12	James Paget University Hospitals NHS Foundation Trust	Great Yarmouth		United Kingdom	NR31 6LA
13	Hull University Teaching Hospitals NHS Trust	Hull		United Kingdom	HU3 2JZ
14	Leeds Teaching Hospitals NHS Trust	Leeds		United Kingdom	LS9 7TF
15	Alder Hey Hospital NHS Foundation Trust	Liverpool		United Kingdom	L12 2AP
16	Moorfields Eye Hospital NHS Foundation Trust	London		United Kingdom	EC1V 2PD
17	Royal Free London NHS Foundation Trust	London		United Kingdom	NW3 2QG
18	St Thomas' Hospital	London		United Kingdom	SE1 7EH
19	Great Ormond Street Hospital NHS Foundation Trust	London		United Kingdom	WC1N 3JH
20	Maidstone and Tunbridge Wells NHS Trust	Maidstone		United Kingdom	ME16 9QQ
21	Manchester University NHS Foundation Trust	Manchester		United Kingdom	M13 9WL
22	Newcastle Upon Tyne Hospitals NHS Foundation Trust	Newcastle		United Kingdom	NE1 4LP
23	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich		United Kingdom	NR4 7UY
24	Nottingham University Hospitals NHS Trust	Nottingham		United Kingdom	NG7 2UH
25	Oxford University Hospitals NHS Foundation Trust	Oxford		United Kingdom	OX3 9DU
26	Sussex Eye Hospital and Royal Alexandra Children's Hospital	Redhill		United Kingdom	RH1 5RH
27	Sheffield Children's Hospitals NHS Foundation Trust	Sheffield		United Kingdom	S10 2TH
28	University Hospital Southampton NHS Foundation Trust	Southampton		United Kingdom	SO16 6YD
29	Southend University Hospital NHS Foundation Trust	Westcliff-on-Sea		United Kingdom	SS0 0RY
30	Royal London Hospital	Whitechapel		United Kingdom	E1 1FR
31	York Teaching Hospital NHS Foundation Trust	York		United Kingdom	YO31 8HE

Sponsors and Collaborators

• Institute of Child Health
• National Institute for Health Research, United Kingdom

Investigators

• Principal Investigator: Ameenat L Solebo, University College London (UCL) Great Ormond Street Institute of Child Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 15, 2020

More Information

Additional Information:

• Study Website
• Study Video

Publications

• 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)

• Responsible Party: Institute of Child Health
• ClinicalTrials.gov Identifier: NCT05385757
• Other Study ID Numbers: 258638
• First Posted: May 23, 2022
• Last Update Posted: May 23, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institute of Child Health: Quality of life; Child; Prospective Cohort; Vision
• Additional relevant MeSH terms: Uveitis

Study Results

No Results Posted as of May 23, 2022