Clinical trial NCT05099588: The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece
Official title: The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece: a Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Keywords: Retinopathy of prematurity
ROP
Treatment
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Athens General Children's Hospital "Pan.&Aglaia Kyriakou", Athens, Greece
name: Agia Sofia Children's Hospital, Athens, Greece
name: Attikon Hospital
name: Iaso Neonatology Clinic, Athens, Greece
name: REA Maternity Hospital, Athens, Greece
name: Ippokratio General Hospital, Thessaloniki, Greece
name: General University Hospital of Patras, Greece
name: General University Hospital of Larisa, Greece
name: University Hospital, Ioannina
name: General University Hospital of Heraklion, Greece
name: Venizeleio General Hospital of Heraklion, Greece
name: General University Hospital of Alexandroupoli, Greece
First posted: 2021-10-29
Enrollment: 43
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All preterm infants who underwent treatment for ROP in a public or private hospital in Greece during the 12-month study period.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of treatment-requiring ROP (TR-ROP) in Greece
timeFrame: During the study period (1 year, prospectively)
Secondary outcomes:
measure: The mean gestational age and birth weight of infants treated for ROP in Greece
timeFrame: During the study period (1 year, prospectively)
measure: The rate of participants treated with laser photocoagulation versus anti-VEGF injection
timeFrame: During the study period (1 year, prospectively)
measure: The failure and recurrence rate of applied treatments for ROP
timeFrame: During the follow-up period (6 months from treatment, prospectively)
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Papageorgiou General Hospital
Study officials:
References:
citation: 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.