NCT05099588

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2.6 years

First QC Date

October 19, 2021

Last Update Submit

February 9, 2023

Conditions

Retinopathy of Prematurity

Keywords

Retinopathy of prematurityROPTreatment

Outcome Measures

Primary Outcomes (1)

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

    During the study period (1 year, prospectively)

Secondary Outcomes (3)

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

    During the study period (1 year, prospectively)

  • The rate of participants treated with laser photocoagulation versus anti-VEGF injection

    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)

Study Arms (1)

Infants treated for ROP

Other: Other: observational study

Interventions

Other: observational studyOTHER

Observational study

Infants treated for ROP

Eligibility Criteria

Age30 Weeks - 50 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • Preterm infants undergoing screening for ROP, who developed TR-ROP and were treated for ROP in one or two eyes.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papageorgiou General Hospital

Thessaloniki, 56429, Greece

Location

Related 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.

    PMID: 28325857BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus

Study Record Dates

First Submitted

October 19, 2021

First Posted

October 29, 2021

Study Start

June 1, 2020

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)