The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece

NCT ID: NCT05099588

Last Updated: 2023-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2023-01-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Retinopathy of Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infants treated for ROP

Other: observational study

Intervention Type OTHER

Observational study

Interventions

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Other: observational study

Observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Weeks

Maximum Eligible Age

50 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Athens General Children's Hospital "Pan.&Aglaia Kyriakou", Athens, Greece

UNKNOWN

Sponsor Role collaborator

Agia Sofia Children's Hospital, Athens, Greece

UNKNOWN

Sponsor Role collaborator

Attikon Hospital

OTHER

Sponsor Role collaborator

Iaso Neonatology Clinic, Athens, Greece

UNKNOWN

Sponsor Role collaborator

REA Maternity Hospital, Athens, Greece

UNKNOWN

Sponsor Role collaborator

Ippokratio General Hospital, Thessaloniki, Greece

UNKNOWN

Sponsor Role collaborator

General University Hospital of Patras, Greece

UNKNOWN

Sponsor Role collaborator

General University Hospital of Larisa, Greece

UNKNOWN

Sponsor Role collaborator

University Hospital, Ioannina

OTHER

Sponsor Role collaborator

General University Hospital of Heraklion, Greece

UNKNOWN

Sponsor Role collaborator

Venizeleio General Hospital of Heraklion, Greece

UNKNOWN

Sponsor Role collaborator

General University Hospital of Alexandroupoli, Greece

UNKNOWN

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Asimina Mataftsi

Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Papageorgiou General Hospital

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 28325857 (View on PubMed)

Other Identifiers

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280/15-04-2020

Identifier Type: -

Identifier Source: org_study_id

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