UveitisUNICORNSNCT05385757
UNICORNS: Uveitis in Childhood Prospective National Cohort Study
An observational study of Uveitis, run by Institute of Child Health at 31 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Uveitis
- How many people
- 250 participants
- Where
- 31 sitesUnited Kingdom
- Study dates
- 22 Oct 2020to Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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)
Who may be able to join
- Children newly diagnosed with uveitis (within previous 6 months)
- Age < 18years
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United Kingdom31 sites
Belfast Royal Victoria Hospital NHS Foundation Trust
Belfast, BT9 7AB
Birmingham Women's and Children's Hospital NHS Foundation Trust
Birmingham, B4 6NH
Royal Bournemouth Christchurch Hospitals NHS Foundation Trust
Bournemouth, BH7 7DW
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ
University Hospitals Bristol NHS Foundation Trust
Bristol, BS1 3NU
Cambridge University Hospital NHS Foundation Trust
Cambridge, CB2 0QQ
Cardiff and Vale University Health Board Hospitals
Cardiff, CF14 4XW
Mid Essex Hospital Trust
Chelmsford, CM1 7ET
Ninewells Hospital
Dundee, DD1 9SY
Princess Alexandra Eye Pavilion
Edinburgh, EH1 3EG
Royal Children's Hospital
Glasgow, G51 4TF
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Alder Hey Hospital NHS Foundation Trust
Liverpool, L12 2AP
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
Royal Free London NHS Foundation Trust
London, NW3 2QG
St Thomas' Hospital
London, SE1 7EH
Great Ormond Street Hospital NHS Foundation Trust
London, WC1N 3JH
Maidstone and Tunbridge Wells NHS Trust
Maidstone, ME16 9QQ
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE1 4LP
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
Sussex Eye Hospital and Royal Alexandra Children's Hospital
Redhill, RH1 5RH
Sheffield Children's Hospitals NHS Foundation Trust
Sheffield, S10 2TH
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, SS0 0RY
Royal London Hospital
Whitechapel, E1 1FR
York Teaching Hospital NHS Foundation Trust
York, YO31 8HE
About this study
Official title: Uveitis in Childhood Prospective National Cohort Study
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.
Read the 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.
- Conditions
- Uveitis
- Keywords
- Quality of life, Child, Prospective Cohort, Vision
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Childhood Uveitis | Children <18 years old newly diagnosed with non-infectious uveitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ocular complications
New incident of sight threatening ocular complications, including glaucoma, cataract and macular oedema
Measured: Up to 3 years
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)
Measured: Up to 3 years
Secondary outcomes (4)
Corticosteroid exposure
Total prescribed topical and systemic corticosteroid burden
Measured: Up to 3 years
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
Measured: Up to 3 years
Health Utility
Child Health Utility Metric (CHU9D), with scores ranging from 0.33 (worst health state) to 1.00 (best health state)
Measured: Up to 3 years
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
Measured: Over one year from baseline to year one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start22 Oct 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Ameenat L Solebo, Principal investigator, University College London (UCL) Great Ormond Street Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385757
- Sponsor's protocol ID
- 258638
- Acronym
- UNICORNS
- Status last verified
- Sep 2024
- First submitted
- 16 Oct 2020
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Authorised collaborators will be granted access to aggregated anonymised data, following review of their research protocol study PI and Co-Is. Data and material transfer agreements will be required to be completed, in order to ensure regulatory compliance and that the interests of the participants are upheld and respected throughout.
Publications
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.
PubMed 38435080
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uveitis in Childhood Prospective National Cohort Study
- ClinicalTrials.gov ID
- NCT05385757
- Acronym / sponsor ID
- UNICORNS / 258638
- Conditions
- Uveitis
- Keywords
- Quality of life, Child, Prospective Cohort, Vision
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Childhood Uveitis | – | –Children <18 years old newly diagnosed with non-infectious uveitis |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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)
Key inclusion criteria (2 listed)
- Children newly diagnosed with uveitis (within previous 6 months)
- Age < 18years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of ocular complications
Time frame: Up to 3 years
New incident of sight threatening ocular complications, including glaucoma, cataract and macular oedema
Pediatric Quality of Life Inventory Score
Time frame: 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)
4 secondary outcomes
Corticosteroid exposure
Time frame: Up to 3 years
Attainment of disease control
Time frame: Up to 3 years
Health Utility
Time frame: Up to 3 years
Change in Pediatric Quality of Life Inventory Score
Time frame: Over one year from baseline to year one
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 38435080Kellett 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.
- Study WebsiteLink provided by the sponsor.
- Study VideoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Authorised collaborators will be granted access to aggregated anonymised data, following review of their research protocol study PI and Co-Is. Data and material transfer agreements will be required to be completed, in order to ensure regulatory compliance and that the interests of the participants are upheld and respected throughout.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ameenat L Solebo principal investigator
University College London (UCL) Great Ormond Street Institute of Child Health
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by Institute of Child Health at 31 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ocular complications (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05385757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.