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Trial record 26 of 70 for:    Recruiting Studies | Diabetic Retinopathy

Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy (EMERALD)

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ClinicalTrials.gov Identifier: NCT03490318
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Belfast Health and Social Care Trust

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 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.


Condition or disease
Proliferative Diabetic Retinopathy Diabetic Macular Edema

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 416 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
Actual Study Start Date : October 26, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with DMO and/or PDR



Primary Outcome Measures :
  1. Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR, using the standard care pathway as the reference standard. [ Time Frame: 30 months ]
    Sensitivity analysis


Secondary Outcome Measures :
  1. Specificity, concordance (agreement) between new pathway (ophthalmic grader pathway) and the standard care pathway, positive and negative likelihood ratios [ Time Frame: 30 months ]
    specificity, concordance, positive and negative likelihood ratios

  2. Cost-effectiveness [ Time Frame: 30 months ]
    specificity analysis, QALY

  3. Acceptability [ Time Frame: 30 months ]
    specificity, concordance, positive and negative likelihood ratios

  4. Proportion of patients requiring subsequent full clinical assessment [ Time Frame: 30 months ]
    specificity, concordance, positive and negative likelihood ratios

  5. Proportions of patients unable to undergo imaging, with inadequate quality images or indeterminate findings. [ Time Frame: 30 months ]
    specificity, concordance, positive and negative likelihood ratios



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults with type 1 or type 2 diabetes with previously successfully treated DMO and/or PDR and in whom, at the time of enrolment in the study, DMO and/or PDR may be active or inactive.
Criteria

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 a CRT of <300 microns and 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490318


Contacts
Contact: Sorcha Finnegan, PhD +44 (0)28 9063 5794 EMERALD@nictu.hscni.net
Contact: Christine McNally +44 (0)28 9063 5794 EMERALD@nictu.hscni.net

Locations
United Kingdom
Queen Margaret Hospital Recruiting
Dunfermline, Scotland, United Kingdom, KY12 0SU
Contact: Caroline Styles         
Royal Victoria Hospital Recruiting
Belfast, United Kingdom
Contact: Noemi Lois         
Bradford Royal Infirmary Recruiting
Bradford, United Kingdom, BD9 6RJ
Contact: Faruque Ghanchi         
Bristol Eye Hospital Recruiting
Bristol, United Kingdom
Contact: Clare Bailey, MD FRCOphth    01173424771    Clare.bailey@bristol.ac.uk   
Frimley Park Hospital Recruiting
Frimley, United Kingdom
Contact: Geeta Menon, FRCS (Ophth)    01276 526982    Geeta.Menon@fhft.nhs.uk   
Gloucestershire Royal Hospital Recruiting
Gloucester, United Kingdom, GL53 7AN
Contact: Peter Scanlon         
Moorfields eye Hospital Recruiting
London, United Kingdom, EC1V 2PD
Contact: Sobha Sivaprasad         
King's College Hospital Recruiting
London, United Kingdom
Contact: Haralabos Eleftheriadis    0203 299 9000    h.eleftheriadis@nhs.net   
Manchester Eye Hospital Recruiting
Manchester, United Kingdom
Contact: Tariq Aslam, FRCSEd    0161 2761234    tariq.aslam@cmft.nhs.uk   
Oxford John Radcliffe Hospital Recruiting
Oxford, United Kingdom
Contact: Samia Fatum, MD    01865 231122    Samia.Fatum@ouh.nhs.uk   
Sheffield Eye Hospital Recruiting
Sheffield, United Kingdom
Contact: Nachiketa Acharya, FRCS    01142261469    Nachiketa.Acharya@sth.nhs.uk   
City Hopsitals Sunderland Recruiting
Sunderland, United Kingdom
Contact: David Steel Steel, FRCOphth    0191 5699039    david.steel@newcastle.ac.uk   
Sponsors and Collaborators
Belfast Health and Social Care Trust
National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: Noemi Lois, PhD, FRCS(Ed). FRCOphth. Queen's University, Belfast

Responsible Party: Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT03490318     History of Changes
Other Study ID Numbers: 17020NL-AS
10856638 ( Registry Identifier: ISRCTN )
17/NI/0124 ( Other Identifier: ORECNI )
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

15.4 Data Sharing Statement

Requests for data sharing will be reviewed on a case by case basis by the CI and TMG.

15.5 Data Access

Following the publication of the primary and secondary outcomes, there may be scope to conduct additional analyses on the data collected. In such instances, formal requests for data will need to be made in writing to the CI who will discuss this with the TMG. In the event of publications arising from such analyses, those responsible will need to provide the CI with a copy of any intended manuscript for approval prior to submission. Authorship will need to take the format of "[name] on behalf of the EMERALD Clinical Trial Group" or something similar, which will be agreed by the TMG.


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Diabetic Angiopathies
Edema
Macular Edema
Papilledema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases