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The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05099588
Acronym
GR-ROP
Enrollment
43
Registered
2021-10-29
Start date
2020-06-01
Completion date
2023-01-15
Last updated
2023-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of prematurity, ROP, Treatment

Brief summary

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.

Interventions

OTHEROther: observational study

Observational study

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Weeks to 50 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The incidence of treatment-requiring ROP (TR-ROP) in GreeceDuring the study period (1 year, prospectively)

Secondary

MeasureTime frame
The mean gestational age and birth weight of infants treated for ROP in GreeceDuring the study period (1 year, prospectively)
The rate of participants treated with laser photocoagulation versus anti-VEGF injectionDuring the study period (1 year, prospectively)
The failure and recurrence rate of applied treatments for ROPDuring the follow-up period (6 months from treatment, prospectively)

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026