The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece

Aristotle University Of Thessaloniki43 enrolled

Overview

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

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

Conditions

Retinopathy of Prematurity

Interventions

Other: observational studyOTHER

Observational study

Eligibility

Sex: ALLMin age: 30 WeeksMax age: 50 Weeks

Medical Language ↔ Plain English

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.

Locations (1)

Papageorgiou General Hospital

Thessaloniki, Greece

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

Time frame: 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)

The failure and recurrence rate of applied treatments for ROP

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

Data from ClinicalTrials.gov

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