Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy: a diagnostic accuracy study

Belfast Health and Social Care Trust0 sites401 target enrollmentAugust 3, 2017

Overview

Phase: 未知
Intervention: Not specified
Conditions: Proliferative diabetic retinopathy (PDR) and diabetic macular oedema (DMO)
Sponsor: Belfast Health and Social Care Trust
Enrollment: 401
Status: Completed
Last Updated: 2 years ago

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31256030 protocol (added 02/07/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34060440/ (added 02/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34083209/ cost analysis results (added 07/06/2021) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33130144/ primary and secondary results (added 19/09/2023)

Registry

who.int

Start Date

August 3, 2017

End Date

December 23, 2019

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

•Current participant inclusion criteria as of 12/03/2019:
•1\. Adults (18 years of age or older)
•2\. Type 1 or 2 diabetes
•3\. Previously successfully treated DMO and/or PDR in one or both eyes and in whom, at the time of enrolment in the study
•4\. DMO and/or PDR may be active or inactive
•4\.1\. Active DMO will be defined as a central subfield retinal thickness (CRT) of \> 300 microns and/or presence of intraretinal/subretinal fluid on spectral domain OCT
•4\.2\. Inactive DMO will be defined as no intraretinal/subretinal fluid
•4\.3\. Active PDR will be defined by the presence of sub\-hyaloid/vitreous haemorrhage and/or active new vessels (new vessels with lack of fibrosis on them)
•4\.4\. Inactive PDR will be defined by the lack of preretinal/vitreous haemorrhage and lack of active new vessels
•Previous participant inclusion criteria: