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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02490254
Other study ID # DALA1021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2014
Est. completion date March 1, 2017

Study information

Verified date April 2022
Source Moorfields Eye Hospital NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 of the first year.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date March 1, 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 16 Years
Eligibility Inclusion Criteria: - Any child (aged 0-16 years) with a new diagnosis of uni or bilateral uveitis. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Surveillance card


Locations

Country Name City State
United Kingdom Moorfields Eye Hospital NHS Foundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
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