The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece (GR-ROP)

February 9, 2023 updated by: Asimina Mataftsi, Aristotle University Of Thessaloniki

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

43

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

  • Greece
      • Thessaloníki, Greece, 56429
        • Papageorgiou General Hospital

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

6 months to 11 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All preterm infants who underwent treatment for ROP in a public or private hospital in Greece during the 12-month study period.

Description

Inclusion Criteria:

  • Preterm infants undergoing screening for ROP, who developed TR-ROP and were treated for ROP in one or two eyes.

Exclusion Criteria:

  • None.

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
Infants treated for ROP
Other: Other: observational study
Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of treatment-requiring ROP (TR-ROP) in Greece
Time Frame: During the study period (1 year, prospectively)
During the study period (1 year, prospectively)

Secondary Outcome Measures

Outcome Measure
Time Frame
The mean gestational age and birth weight of infants treated for ROP in Greece
Time Frame: During the study period (1 year, prospectively)
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)
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)
During the follow-up period (6 months from treatment, prospectively)

Collaborators and Investigators

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

Sponsor

Aristotle University Of Thessaloniki

Collaborators

Athens General Children's Hospital "Pan.&Aglaia Kyriakou", Athens, Greece
Agia Sofia Children's Hospital, Athens, Greece
Attikon General Hospital, Athens, Greece
Iaso Neonatology Clinic, Athens, Greece
REA Maternity Hospital, Athens, Greece
Ippokratio General Hospital, Thessaloniki, Greece
General University Hospital of Patras, Greece
General University Hospital of Larisa, Greece
General University Hospital of Ioannina, Greece
General University Hospital of Heraklion, Greece
Venizeleio General Hospital of Heraklion, Greece
General University Hospital of Alexandroupoli, Greece

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 (ACTUAL)

June 1, 2020

Primary Completion (ACTUAL)

January 15, 2023

Study Completion (ACTUAL)

January 15, 2023

Study Registration Dates

First Submitted

October 19, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (ACTUAL)

October 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 280/15-04-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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