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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03490318
Other study ID # 17020NL-AS
Secondary ID 1085663817/NI/01
Status Completed
Phase
First received
Last updated
Start date October 26, 2017
Est. completion date December 23, 2019

Study information

Verified date February 2022
Source Belfast Health and Social Care Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Given the high number of people with DMO and PDR, the need for patients to be seen at short follow-up intervals, the need for frequent treatments and the requirement for long-term follow-up, there is a very large workload in Hospital Eye Services related to DMO/PDR which is making it difficult for the NHS to cope with the demand, in particular, due to shortage of ophthalmologists. This is only expected to get worse given the increasing prevalence of DM. Identifying new ways of increasing the NHS capacity and efficiency without compromising the quality of care would greatly benefit the NHS. The purpose of this study is to determine whether successfully treated patients with DMO and PDR could be followed up without a face-to-face examination by an ophthalmologist. EMERALD will evaluate a new care pathway which will include multimodal retinal imaging and separate image assessment by trained ophthalmic graders. This new pathway will be compared to the current standard care pathway: for DMO: ophthalmologist evaluating patients in clinic by slit-lamp biomicroscopy and with access to OCT images; for PDR ophthalmologists evaluating patients in clinic by slit-lamp biomicroscopy. EMERALD will compare how accurate the new pathway is at determining which patients have active or inactive disease. The costs and acceptability of current and new models of care will also be compared.


Description:

1. Research Hypothesis The hypothesis is that the new form of surveillance for people with stable DMO and/or PDR will be as sensitive as the current standard of care but at a lower cost. 2. Study Aim EMERALD aims to determine the diagnostic performance and cost-effectiveness of a new form of surveillance for people with stable DMO and/or PDR, using the current standard of care as the reference standard. 3. Study Objectives The specific objectives of this study are to evaluate the new surveillance pathway to: 1. Quantify and compare the diagnostic accuracy (in terms of sensitivity, specificity, overall agreement, positive and negative likelihood ratios) of the new pathway of surveillance (ophthalmic grader pathway) using the current standard of care pathway as the reference standard. This will be done separately for DMO and PDR. 2. Assess acceptability of the new surveillance pathway. 3. Determine the proportion of patients requiring subsequent full clinical assessment by an ophthalmologist under the new pathway. 4. Determine the proportion of patients unable to undergo imaging tests, with images of inadequate quality and indeterminate findings under the new pathway. 5. Establish relative cost-effectiveness of the new surveillance pathway. 4. Outcome measures 4.1 Primary outcome The primary outcome measure is: • Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR, using the standard care pathway as the reference standard. 4.2 Secondary outcomes There are a number of secondary outcomes which will be measured and include: - Specificity, concordance (agreement) between new pathway (ophthalmic grader pathway) and the standard care pathway, positive and negative likelihood ratios - Cost-effectiveness - Acceptability - Proportion of patients requiring subsequent full clinical assessment - Proportions of patients unable to undergo imaging, with inadequate quality images or indeterminate findings. 5. STUDY DESIGN 5.1 Study Design EMERALD is a prospective, cross-sectional diagnostic study of patients with diabetic retinopathy and DMO or PDR (or both) who had been previously successfully treated and who, at the time of enrolment in the study, may have active or inactive disease (both are required to evaluate the diagnostic performance of the new pathway). Specifically, EMERALD will have a case-referent cross-sectional diagnostic study design with both sampling (selection) of patients and data collection carried out prospectively (18). This approach provides both a cost-efficient study design while also having a low risk of bias in terms of diagnostic accuracy (19) 5.2 Study Setting Specialist Hospital Eye Services (HES) in the UK. All centres involved have extensive experience with the management of patients with diabetic retinopathy, DMO and PDR. 6. End of Study For the purposes of submitting the end of trial notification to the Sponsor and the Research Ethics Committee (REC), the end of trial will be considered to be when the database lock occurs for the final analysis. The trial will be stopped prematurely if: - Mandated by the REC - Mandated by the Sponsor (e.g. following recommendations from the Trial Steering Committee (TSC) - Funding for the trial ceases The REC that originally gave a favourable opinion of the trial will be notified in writing when the trial has been concluded or if it is terminated early.


Recruitment information / eligibility

Status Completed
Enrollment 401
Est. completion date December 23, 2019
Est. primary completion date December 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults (18 years of age or older) with type 1 or 2 diabetes with previously successfully treated DMO and/or PDR in one or both eyes and in whom, at the time of enrolment in the study, DMO and/or PDR may be active or inactive. - 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. - Inactive DMO will be defined as no intraretinal/subretinal fluid - 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) - Inactive PDR will be defined by the lack of preretinal/vitreous haemorrhage and lack of active new vessels. Exclusion Criteria: - Unable to provide informed consent - Patients do not read, speak or understand English

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Royal Victoria Hospital Belfast
United Kingdom Bradford Royal Infirmary Bradford
United Kingdom Bristol Eye Hospital Bristol
United Kingdom Queen Margaret Hospital Dunfermline Scotland
United Kingdom Frimley Park Hospital Frimley
United Kingdom Gloucestershire Royal Hospital Gloucester
United Kingdom King's College Hospital London
United Kingdom Moorfields eye Hospital London
United Kingdom Manchester Eye Hospital Manchester
United Kingdom James Cook University Hopsital Middlesbrough North Yorkshire
United Kingdom Oxford John Radcliffe Hospital Oxford
United Kingdom Sheffield Eye Hospital Sheffield
United Kingdom City Hopsitals Sunderland Sunderland

Sponsors (2)

Lead Sponsor Collaborator
Belfast Health and Social Care Trust National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR, using the standard care pathway as the reference standard. Sensitivity analysis 30 months
Secondary Specificity, concordance (agreement) between new pathway (ophthalmic grader pathway) and the standard care pathway, positive and negative likelihood ratios specificity, concordance, positive and negative likelihood ratios 30 months
Secondary Cost-effectiveness specificity analysis, QALY 30 months
Secondary Acceptability specificity, concordance, positive and negative likelihood ratios 30 months
Secondary Proportion of patients requiring subsequent full clinical assessment specificity, concordance, positive and negative likelihood ratios 30 months
Secondary Proportions of patients unable to undergo imaging, with inadequate quality images or indeterminate findings. specificity, concordance, positive and negative likelihood ratios 30 months
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