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 个研究点目标入组 401 人开始时间: 2017年8月3日最近更新: 2023年10月3日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方: Belfast Health and Social Care Trust
入组人数: 401

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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)

研究设计

研究类型: Observational

入排标准

性别: All

入选标准

•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:
•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 a CRT of <300 microns and 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

排除标准

•1. Unable to provide informed consent
•2. Patients do not read, speak or understand English

研究者

发起方

Belfast Health and Social Care Trust

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