The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece

Retinopathy of Prematurity Clinical Trial

— GR-ROP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05099588
• Other study ID #: 280/15-04-2020
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: January 15, 2023

Study information

• Verified date: February 2023
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 50 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Other:
• Other: observational study
Observational study

Locations

Country	Name	City	State
Greece	Papageorgiou General Hospital	Thessaloníki

Sponsors (13)

Lead Sponsor

Collaborator

Aristotle University Of Thessaloniki

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

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of treatment-requiring ROP (TR-ROP) in Greece		During the study period (1 year, prospectively)
Secondary	The mean gestational age and birth weight of infants treated for ROP in Greece		During the study period (1 year, prospectively)
Secondary	The rate of participants treated with laser photocoagulation versus anti-VEGF injection		During the study period (1 year, prospectively)
Secondary	The failure and recurrence rate of applied treatments for ROP		During the follow-up period (6 months from treatment, prospectively)