UveitisNCT02490254
Childhood Uveitis Initial Management and One-year Outcomes
An observational study of Uveitis, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators wish to establish a robust estimate of the incidence of inflammation inside the eye (uveitis) in children age 0-16 years in the UK, which hospitals children present to, where they are referred to, which treatment they receive during the first year after diagnosis, and how well they can see at the end… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Uveitis
- What is being tested?
- Surveillance card
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2014to 1 Mar 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis.
Who may be able to join
- Any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis.
Who cannot join
- In England/Wales/Northern Ireland, children who are known to have pre existing juvenile idiopathic arthritis (joint inflammation) will be excluded. No exclusions will apply to the Scotland cohort.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
About this study
Official title: Childhood Uveitis Not Associated With Juvenile Idiopathic Arthritis: Incidence, Initial Management and One-year Outcomes
The investigators wish to establish a robust estimate of the incidence of inflammation inside the eye (uveitis) in children age 0-16 years in the UK, which hospitals children present to, where they are referred to, which treatment they receive during the first year after diagnosis, and how well they can see at the end of the first year.
Read the detailed description
The investigators therefore propose to run a high quality surveillance study, together with the British Ophthalmological Surveillance Unit (BOSU) at the Royal College of Ophthalmologists and with the Scottish Ophthalmological Surveillance Unit (SOSU). BOSU and SOSU operate a monthly reporting card scheme. All UK consultant ophthalmologists and associate specialists receive a monthly 'report card' with a list of conditions being surveyed. Reporting clinicians will tick a box if they have seen a case of childhood uveitis in the preceding month, and return the card to BOSU/SOSU, who will inform us, the study investigators.
Following reporting of a new case, the investigators will directly contact reporting clinicians and send them a clinical proforma to collect clinical details about the case. At 12 months, a follow up questionnaire will be sent. The investigators will use only information available from patient case notes, with no direct patient contact. The investigators principal aim is to determine incidence of childhood uveitis in the UK. Secondary aims are to identify presentation patterns, referral pathways, associated medical conditions, management, and outcomes.
- Conditions
- Uveitis
- Being tested
- Surveillance card
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveillance cardOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis. Receives: Other: Surveillance card |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the total number of reported cases of uveitis.
A clinical proforma will be sent to the investigators collect clinical details about the case. At 12 months, a followup questionnaire will be sent.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study start1 Nov 2014
- Primary completionMar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Dahlmann-Noor, Dr Med PhD, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490254
- Sponsor's protocol ID
- DALA1021
- Status last verified
- Apr 2022
- First submitted
- 25 Jun 2015
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Uveitis Not Associated With Juvenile Idiopathic Arthritis: Incidence, Initial Management and One-year Outcomes
- ClinicalTrials.gov ID
- NCT02490254
- Acronym / sponsor ID
- DALA1021
- Conditions
- Uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 3 Jul 2015 (estimated)
- 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.
The investigators wish to establish a robust estimate of the incidence of inflammation inside the eye (uveitis) in children age 0-16 years in the UK, which hospitals children present to, where they are referred to, which treatment they receive during the first year after diagnosis, and how well they can see at the end of the first year.
Detailed description
The investigators therefore propose to run a high quality surveillance study, together with the British Ophthalmological Surveillance Unit (BOSU) at the Royal College of Ophthalmologists and with the Scottish Ophthalmological Surveillance Unit (SOSU). BOSU and SOSU operate a monthly reporting card scheme. All UK consultant ophthalmologists and associate specialists receive a monthly 'report card' with a list of conditions being surveyed. Reporting clinicians will tick a box if they have seen a case of childhood uveitis in the preceding month, and return the card to BOSU/SOSU, who will inform us, the study investigators.
Following reporting of a new case, the investigators will directly contact reporting clinicians and send them a clinical proforma to collect clinical details about the case. At 12 months, a follow up questionnaire will be sent. The investigators will use only information available from patient case notes, with no direct patient contact. The investigators principal aim is to determine incidence of childhood uveitis in the UK. Secondary aims are to identify presentation patterns, referral pathways, associated medical conditions, management, and outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Surveillance cardAny child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis.
Key inclusion criteria (1 listed)
- Any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis.
Key exclusion criteria (1 listed)
- In England/Wales/Northern Ireland, children who are known to have pre existing juvenile idiopathic arthritis (joint inflammation) will be excluded. No exclusions will apply to the Scotland cohort.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surveillance card | Other | 1 |
Primary outcome
The primary outcome measure will be the total number of reported cases of uveitis.
Time frame: 1 year
A clinical proforma will be sent to the investigators collect clinical details about the case. At 12 months, a followup questionnaire will be sent.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
Annegret Dahlmann-Noor, Dr Med PhD principal investigator
Moorfields Eye Hospital NHS Foundation Trust
1 site 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 Moorfields Eye Hospital NHS Foundation Trust at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome measure will be the total number of reported cases of uveitis. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2022.