Effectiveness of multimodal imaging for the evaluation of retinal oedema and new vessels in diabetic retinopathy

Not Applicable

Completed

• Conditions: Proliferative diabetic retinopathy (PDR) and diabetic macular oedema (DMO); Eye Diseases; 1. Proliferative diabetic retinopathy (PDR)2. Diabetic macular edema (DME)

• Registration Number: ISRCTN10856638
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-03
• Study Completion: 2019-12-23
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR is assessed by evaluating the Case Report Forms (CRFs) at baseline

Secondary Outcome Measures

Name	Time	Method
1. Specificity, concordance (agreement) between the new pathway (ophthalmic grader pathway) and the standard care pathway, positive and negative likelihood ratios are assessed by evaluating the CRFs at baseline<br>2. Cost-effectiveness is assessed by evaluating the CRFs and the EQ-5D questionnaire at baseline<br>3. Acceptability is assessed by evaluating the Focus Group Discussion feedback at baseline<br>4. Proportion of patients requiring subsequent full clinical assessment is assessed by evaluating the CRFs at baseline<br>5. Proportion of patients unable to undergo imaging, with inadequate quality images or indeterminate findings, is assessed by evaluating the CRFs at baseline