Retinopathy of PrematurityGR-ROPNCT05099588
The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece
An observational study of Retinopathy of Prematurity, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
A prospective observational study of the incidence of treatment-requiring ROP (TR-ROP), at a national level, in Greece. Read more about this study
- Who is it for?
- Ages 30 to 50 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Other: observational study
- How many people
- 43 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2020to 15 Jan 2023
- 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 30 to 50 weeks
- All sexes
- No healthy volunteers
- Child
Study population: All preterm infants who underwent treatment for ROP in a public or private hospital in Greece during the 12-month study period.
Who may be able to join
- Preterm infants undergoing screening for ROP, who developed TR-ROP and were treated for ROP in one or two eyes.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece: a Multicenter Prospective Cohort Study
A prospective observational study of the incidence of treatment-requiring ROP (TR-ROP), at a national level, in Greece.
Read the detailed description
The purpose of this observational study is to prospectively collect data on ROP cases necessitating treatment at a national level. Each and every ROP screening unit in Greece (collaborating centers) report their new TR-ROP cases, their demographics and treatment characteristics, monthly, for a 12-month period. A reminder email is sent to avoid under-reporting due to neglect. Data are collected by the Responsible Party and will be analyzed together with national registry data on all preterm births in the same 12-month period.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Other: observational study
- Keywords
- Retinopathy of prematurity, ROP, Treatment
- 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.
Other: observational studyOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Infants treated for ROP | Not described Receives: Other: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of treatment-requiring ROP (TR-ROP) in Greece
Measured: During the study period (1 year, prospectively)
Secondary outcomes (3)
The mean gestational age and birth weight of infants treated for ROP in Greece
Measured: During the study period (1 year, prospectively)
The rate of participants treated with laser photocoagulation versus anti-VEGF injection
Measured: During the study period (1 year, prospectively)
The failure and recurrence rate of applied treatments for ROP
Measured: During the follow-up period (6 months from treatment, prospectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Jun 2020
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
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.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Aghia Sophia Children's Hospital of Athens, Attikon Hospital, Iaso Neonatology Clinic, Athens, Greece, REA Maternity Hospital, Athens, Greece, Ippokratio General Hospital, Thessaloniki, Greece, General Hospital of Larissa, University Hospital, Ioannina, University General Hospital of Heraklion, Venizeleio General Hospital of Heraklion, Greece, General University Hospital of Alexandroupoli, Greece
- Responsible party
- Principal investigator, Asimina Mataftsi, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099588
- Sponsor's protocol ID
- 280/15-04-2020
- Acronym
- GR-ROP
- Status last verified
- Feb 2023
- First submitted
- 19 Oct 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05099588
- Acronym / sponsor ID
- GR-ROP / 280/15-04-2020
- Conditions
- Retinopathy of Prematurity
- Keywords
- Retinopathy of prematurity, ROP, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Athens General Children's Hospital "Pan. & Aglaia Kyriakou", Aghia Sophia Children's Hospital of Athens, Attikon Hospital, Iaso Neonatology Clinic, Athens, Greece, REA Maternity Hospital, Athens, Greece, Ippokratio General Hospital, Thessaloniki, Greece, General Hospital of Larissa, University Hospital, Ioannina, University General Hospital of Heraklion, Venizeleio General Hospital of Heraklion, Greece, General University Hospital of Alexandroupoli, Greece
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 29 Oct 2021 (actual)
- 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.
A prospective observational study of the incidence of treatment-requiring ROP (TR-ROP), at a national level, in Greece.
Detailed description
The purpose of this observational study is to prospectively collect data on ROP cases necessitating treatment at a national level. Each and every ROP screening unit in Greece (collaborating centers) report their new TR-ROP cases, their demographics and treatment characteristics, monthly, for a 12-month period. A reminder email is sent to avoid under-reporting due to neglect. Data are collected by the Responsible Party and will be analyzed together with national registry data on all preterm births in the same 12-month period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants treated for ROP | – | Other: Other: observational study |
Who may qualify
- Ages
- 30 to 50 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All preterm infants who underwent treatment for ROP in a public or private hospital in Greece during the 12-month study period.
Key inclusion criteria (1 listed)
- Preterm infants undergoing screening for ROP, who developed TR-ROP and were treated for ROP in one or two eyes.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Other: observational studyObservational study | Other | Infants treated for ROP |
Primary outcome
The incidence of treatment-requiring ROP (TR-ROP) in Greece
Time frame: During the study period (1 year, prospectively)
3 secondary outcomes
The mean gestational age and birth weight of infants treated for ROP in Greece
Time frame: During the study period (1 year, prospectively)
The rate of participants treated with laser photocoagulation versus anti-VEGF injection
Time frame: During the study period (1 year, prospectively)
The failure and recurrence rate of applied treatments for ROP
Time frame: During the follow-up period (6 months from treatment, prospectively)
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 10 Feb 2023.
- Background: 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aristotle University Of Thessaloniki at 1 site in Greece.
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 10 Feb 2023. 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 Greece. 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?
The incidence of treatment-requiring ROP (TR-ROP) in Greece (time frame: During the study period (1 year, prospectively)). 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 NCT05099588, 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 10 Feb 2023.