UK Surveillance of Treated Retinopathy of Prematurity

March 15, 2016 updated by: Moorfields Eye Hospital NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Babies with retinopathy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Other: Surviellance card

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of babies requiring treatment for retinopathy of prematurity in the UK
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moorfields Eye Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Annegret Dahlmann-Noor, Moorfields Eye Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DALA1012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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