Retinopathy of PrematurityNCT02484989
UK Surveillance of Treated Retinopathy of Prematurity
An observational study of Retinopathy of Prematurity, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Surviellance card
- How many people
- 270 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to Jul 2015
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Babies with retinopathy
Who may be able to join
- 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)
Who cannot join
- None; we will monitor data to exclude duplication of cases which may arise from children being transferred between neonatal units or consultants
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London, London, EC1V 2PD
About this study
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.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Surviellance card
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surviellance cardOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Surviellance card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of babies requiring treatment for retinopathy of prematurity in the UK
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Dahlmann-Noor, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484989
- Sponsor's protocol ID
- DALA1012
- Status last verified
- Mar 2016
- First submitted
- 25 Jun 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28325857
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UK Surveillance of Treated Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT02484989
- Acronym / sponsor ID
- DALA1012
- Conditions
- Retinopathy of Prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinopathy of prematurity | – | Other: Surviellance cardAny 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) |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies with retinopathy
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- None; we will monitor data to exclude duplication of cases which may arise from children being transferred between neonatal units or consultants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surviellance card | Other | Retinopathy of prematurity |
Primary outcome
Incidence of babies requiring treatment for retinopathy of prematurity in the UK
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Derived from this study: PubMed 28325857Adams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annegret Dahlmann-Noor principal investigator
Moorfields Eye Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy of Prematurity, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of babies requiring treatment for retinopathy of prematurity in the UK (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.