UK Surveillance of Treated Retinopathy of Prematurity
1 other identifier
observational
270
1 country
1
Brief Summary
Currently, there is little recent data on regional variations in treatment methods, neonatal units that provide retinopathy (ROP) treatment, facilities for treatment available at each unit including anaesthetic support for such preterm babies, facilities to transfer babies to units that offer treatment etc. While some parts of the UK have established neonatal networks and agreements among units for ROP treatment, in other parts, such arrangements are illdefined. The number of babies needing ROP treatment may be higher since the introduction of revised guidelines in 2008 as earlier treatment has been shown to be beneficial. Collecting epidemiological data through the British Ophthalmic Surveillance Unit (BOSU) on the incidence of treatable ROP, the treatment methods used and facilities for treatment will provide the foundation for effective planning of resources and manpower to deal with the additional demand.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 25, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMarch 16, 2016
March 1, 2016
2.2 years
June 25, 2015
March 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of babies requiring treatment for retinopathy of prematurity in the UK
1 year
Study Arms (1)
Retinopathy of prematurity
Any baby with ROP who is treated or referred to another unit for treatment either in the form of laser therapy, cryotherapy, antiVEGF agent or vitrectomy/scleral buckling (or a combination of above treatments)
Interventions
Eligibility Criteria
Babies with retinopathy
You may qualify if:
- Any baby with ROP who is treated or referred to another unit for treatment either in the form of laser therapy, cryotherapy, antiVEGF agent or vitrectomy/scleral buckling (or a combination of above treatments)
You may not qualify if:
- None; we will monitor data to exclude duplication of cases which may arise from children being transferred between neonatal units or consultants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moorfields Eye Hospital NHS Foundation Trust
London, London, EC1V 2PD, United Kingdom
Related Publications (1)
Adams GG, Bunce C, Xing W, Butler L, Long V, Reddy A, Dahlmann-Noor AH. Treatment trends for retinopathy of prematurity in the UK: active surveillance study of infants at risk. BMJ Open. 2017 Mar 21;7(3):e013366. doi: 10.1136/bmjopen-2016-013366.
PMID: 28325857DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annegret Dahlmann-Noor
Moorfields Eye Hospital NHS Foundation Trust
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2015
First Posted
June 30, 2015
Study Start
May 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
March 16, 2016
Record last verified: 2016-03