UK Surveillance of Treated Retinopathy of Prematurity

Retinopathy of Prematurity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484989
• Other study ID #: DALA1012
• Status: Completed
• Phase: N/A
• First received: June 25, 2015
• Last updated: March 15, 2016
• Start date: May 2013
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scotland: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• None; we will monitor data to exclude duplication of cases which may arise from children being transferred between neonatal units or consultants

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Other:
• Surviellance 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	Incidence of babies requiring treatment for retinopathy of prematurity in the UK		1 year	No