GR-ROP: The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05099588
• Collaborator: Athens General Children's Hospital "Pan.&Aglaia Kyriakou", Athens, Greece (Other), Agia Sofia Children's Hospital, Athens, Greece (Other), Attikon General Hospital, Athens, Greece (Other), Iaso Neonatology Clinic, Athens, Greece (Other), REA Maternity Hospital, Athens, Greece (Other), Ippokratio General Hospital, Thessaloniki, Greece (Other), General University Hospital of Patras, Greece (Other), General University Hospital of Larisa, Greece (Other), General University Hospital of Ioannina, Greece (Other), General University Hospital of Heraklion, Greece (Other), Venizeleio General Hospital of Heraklion, Greece (Other), General University Hospital of Alexandroupoli, Greece (Other)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retinopathy of Prematurity	Other: Other: observational study

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Incidence of Treatment-requiring Retinopathy of Prematurity in Greece: a Multicenter Prospective Cohort Study
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Infants treated for ROP	Other: Other: observational study; Observational study

Outcome Measures

Primary Outcome Measures

1. The incidence of treatment-requiring ROP (TR-ROP) in Greece [During the study period (1 year, prospectively)]

Secondary Outcome Measures

1. The mean gestational age and birth weight of infants treated for ROP in Greece [During the study period (1 year, prospectively)]

2. The rate of participants treated with laser photocoagulation versus anti-VEGF injection [During the study period (1 year, prospectively)]

3. The failure and recurrence rate of applied treatments for ROP [During the follow-up period (6 months from treatment, prospectively)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Weeks to 50 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Papageorgiou General Hospital	Thessaloníki		Greece	56429

Sponsors and Collaborators

• Aristotle University Of Thessaloniki
• Athens General Children's Hospital "Pan.&Aglaia Kyriakou", Athens, Greece
• Agia Sofia Children's Hospital, Athens, Greece
• Attikon General Hospital, Athens, Greece
• Iaso Neonatology Clinic, Athens, Greece
• REA Maternity Hospital, Athens, Greece
• Ippokratio General Hospital, Thessaloniki, Greece
• General University Hospital of Patras, Greece
• General University Hospital of Larisa, Greece
• General University Hospital of Ioannina, Greece
• General University Hospital of Heraklion, Greece
• Venizeleio General Hospital of Heraklion, Greece
• General University Hospital of Alexandroupoli, Greece

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Asimina Mataftsi, Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus, Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT05099588
• Other Study ID Numbers: 280/15-04-2020
• First Posted: Oct 29, 2021
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Asimina Mataftsi, Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus, Aristotle University Of Thessaloniki: Retinopathy of prematurity; ROP; Treatment
• Additional relevant MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth

Study Results

No Results Posted as of Feb 15, 2022