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Trial record 23 of 293 for:    retinopathy of prematurity

UK Surveillance of Treated Retinopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT02484989
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Retinopathy of Prematurity Other: Surviellance card

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Study Type : Observational [Patient Registry]
Actual Enrollment : 270 participants
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Study Start Date : May 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015


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



Primary Outcome Measures :
  1. Incidence of babies requiring treatment for retinopathy of prematurity in the UK [ Time Frame: 1 year ]


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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Babies with retinopathy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484989


Locations
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United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Annegret Dahlmann-Noor Moorfields Eye Hospital NHS Foundation Trust

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02484989     History of Changes
Other Study ID Numbers: DALA1012
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases