The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece
Completed
- Conditions
- Retinopathy of Prematurity
- Registration Number
- NCT05099588
- Lead Sponsor
- Aristotle University Of Thessaloniki
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of treatment-requiring ROP (TR-ROP) in Greece During the study period (1 year, prospectively)
- Secondary Outcome Measures
Name Time Method The rate of participants treated with laser photocoagulation versus anti-VEGF injection During the study period (1 year, prospectively) The mean gestational age and birth weight of infants treated for ROP in Greece During the study period (1 year, prospectively) The failure and recurrence rate of applied treatments for ROP During the follow-up period (6 months from treatment, prospectively)
Trial Locations
- Locations (1)
Papageorgiou General Hospital
🇬🇷ThessalonÃki, Greece