Ignite Creation Date:
2024-05-06 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03490318
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2017-12-05
Brief Title:
Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
Sponsor:
Belfast Health and Social Care Trust
Organization:
Belfast Health and Social Care Trust
Study Overview
Official Title:
Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMERALD
Brief 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 DMOPDR 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
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
Detailed Description:
1 Research Hypothesis
The hypothesis is that the new form of surveillance for people with stable DMO andor 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 andor 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
41 Primary outcome
The primary outcome measure is
Sensitivity of the new pathway ophthalmic grader pathway in detecting active DMOPDR using the standard care pathway as the reference standard
42 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
51 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
52 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 eg 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
The hypothesis is that the new form of surveillance for people with stable DMO andor 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 andor 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
41 Primary outcome
The primary outcome measure is
Sensitivity of the new pathway ophthalmic grader pathway in detecting active DMOPDR using the standard care pathway as the reference standard
42 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
51 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
52 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17NI0124 | OTHER | ORECNI | None |
| 10856638 | REGISTRY | None | None |