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Completed

NCT Number: NCT05099588

The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece

A prospective observational study of the incidence of treatment-requiring ROP (TR-ROP), at a national level, in Greece.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

30 week–50 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Papageorgiou General Hospital

Thessaloniki, 56429, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Other: observational study

Other

Observational study

Primary outcomes

  1. The incidence of treatment-requiring ROP (TR-ROP) in Greece

    Time frame: During the study period (1 year, prospectively)

Secondary outcomes

  1. The mean gestational age and birth weight of infants treated for ROP in Greece

    Time frame: During the study period (1 year, prospectively)

  2. The rate of participants treated with laser photocoagulation versus anti-VEGF injection

    Time frame: During the study period (1 year, prospectively)

  3. The failure and recurrence rate of applied treatments for ROP

    Time frame: During the follow-up period (6 months from treatment, prospectively)

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Aghia Sophia Children's Hospital of Athens
  • Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
  • Attikon Hospital
  • General Hospital of Larissa
  • General University Hospital of Alexandroupoli, Greece
  • Iaso Neonatology Clinic, Athens, Greece
  • Ippokratio General Hospital, Thessaloniki, Greece
  • REA Maternity Hospital, Athens, Greece
  • University General Hospital of Heraklion
  • University Hospital, Ioannina
  • Venizeleio General Hospital of Heraklion, Greece

Registry information

Official study title

The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece: a Multicenter Prospective Cohort Study

Acronym: GR-ROP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2021
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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