UK Surveillance of Treated Retinopathy of Prematurity

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Other: Surviellance card

• Registration Number: NCT02484989
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-06-30
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retinopathy of prematurity	Surviellance card	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)

Primary Outcome Measures

Name	Time	Method
Incidence of babies requiring treatment for retinopathy of prematurity in the UK	1 year

Trial Locations

Locations (1)

Moorfields Eye Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom