Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 13
- 主要终点
- Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR, using the standard care pathway as the reference standard.
研究概览
简要总结
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.
详细描述
- 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:
- 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.
- Assess acceptability of the new surveillance pathway.
- Determine the proportion of patients requiring subsequent full clinical assessment by an ophthalmologist under the new pathway.
- Determine the proportion of patients unable to undergo imaging tests, with images of inadequate quality and indeterminate findings under the new pathway.
- Establish relative cost-effectiveness of the new surveillance pathway.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Unable to provide informed consent
- •Patients do not read, speak or understand English
结局指标
主要结局
Sensitivity of the new pathway (ophthalmic grader pathway) in detecting active DMO/PDR, using the standard care pathway as the reference standard.
时间窗: 30 months
Sensitivity analysis
次要结局
- Cost-effectiveness(30 months)
- Proportions of patients unable to undergo imaging, with inadequate quality images or indeterminate findings.(30 months)
- Acceptability(30 months)
- Proportion of patients requiring subsequent full clinical assessment(30 months)
- Specificity, concordance (agreement) between new pathway (ophthalmic grader pathway) and the standard care pathway, positive and negative likelihood ratios(30 months)