The Incidence of Treatment-requiring Retinopathy of Prema... | NCT05099588

Studies
The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece

NCT05099588

Sponsor

Aristotle University Of Thessaloniki

Status

Completed

Last Update Posted

Feb 10, 2023Actual

Enrollment

43Actual

Phase

Not provided

Conditions

Retinopathy of Prematurity

Interventions

Other: observational study

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Jan 15, 2023Actual

Completion Date

Jan 15, 2023Actual

First Submitted Date

Oct 19, 2021

First Submission Date that Met QC Criteria

Oct 19, 2021

First Posted Date

Oct 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2023

Last Update Posted Date

Feb 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Asimina Mataftsi, Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus, Aristotle University Of ThessalonikiPrincipal Investigator

Lead Sponsor

Aristotle University Of ThessalonikiOTHER

Collaborators

Name	Class
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"	OTHER
Aghia Sophia Children's Hospital of Athens	OTHER
Attikon Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infants treated for ROP			Other: Other: observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Other: observational study	Other	Observational study	Infants treated for ROP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of treatment-requiring ROP (TR-ROP) in Greece		During the study period (1 year, prospectively)

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Weeks

Maximum Age

50 Weeks

Standard Ages

Child

Study Population

All preterm infants who underwent treatment for ROP in a public or private hospital in Greece during the 12-month study period.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Papageorgiou General Hospital		Thessaloniki		56429	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28325857	Background	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.

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases