Feasibility of an Alternative Pathway for Hospital Referrals From Diabetic Eye Screening Wales (DESW) for People Suspected With Sight-threatening Diabetic Eye Disease Diabetic Maculopathy (FARSight-DM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Time from referral to treatment
研究概览
简要总结
To assess a pathway using opticians based in their practices and a 'virtual' review by a consultant ophthalmologist, based in the hospital to assess suspected diabetic maculopathy. We want to know if this pathway works, is it acceptable to people with diabetes and what the changes might mean in terms of the outcomes for patients and NHS resources and cost?
Screening by Diabetic Eye Service Wales currently involves taking and as-sessing 2-D (dimensional) digital photographs of the back of the eye (reti-na). Leakage from damaged blood vessels can cause swelling within the central part of the retina, known as maculopathy. This swelling cannot be seen on traditional 2-D images.
Diagnosing maculopathy requires a 3-D camera and a technique known as Optical Coherence Tomography (OCT). OCT is not part of routine screening but, is available in the Hospital Eye Service (HES) and many optician prac-tices. If any changes are seen in the macular region of the retina on 2-D images, the patient will require an OCT scan to see if there is any in-creased thickness. Many patients do not have increased thickness and not everyone with diabetic retinopathy has maculopathy.
Currently after screening, patients who have macular changes that suggest possible maculopathy are referred to the HES for OCT imaging. Many of these patients will not have increased thickness and the appointment could have been better used to see a different patient with increased thickness that requires treatment.
The new pathway that will be investigated in this study involves trained opticians in practices that have an OCT camera taking the required 3-D images and carrying out the initial examination. The images and patient record will then be reviewed by an ophthalmologist working virtually, to decide the management plan. If this pathway is safe and acceptable to people with diabetes, it would reduce the pressure on HES clinics. It will also develop new skills for opticians and allow people to be seen closer to their home, reducing the stress that referrals can create and lowering the carbon footprint of the service.
详细描述
1 Background Diabetes mellitus, as estimated by the International Diabetes Federation (IDF), affects 537 mil-lion people globally which is expected to increase to 783 million by 2045. DED is amongst the commonest and most feared complications of diabetes consisting of diabetic retinopathy and diabetic macular oedema. In 2020, world-wide, 103 million people were estimated to have DED, 15 million with vision threatening DED and 29 million having diabetic macular oedema, projected to reach 161 million, 45 million and 77 million respectively by 2045.
Until recently, DED has been the leading cause of blindness (Severe Sight Impairment, SSI) in the working age population in developed countries. However, since the introduction of screening for DED in the UK, along with improvements in diabetes and ophthalmological care, DED is no longer the leading cause of SSI in the UK. In Wales, new certifications for both sight impairment (SI) and SSI have fallen by 50% since screening commenced.
Screening for DED in Wales is performed by the DESW, utilising digital photography performed by trained photographers and the images are graded by trained readers, utilising standardised protocols and quality assurance. All cases of sight-threatening diabetic retinopathy (DR) i.e., severe pre-proliferative DR, proliferative DR and diabetic maculopathy require referral to ophthalmology for review and/or treatment. However, 2-dimensional (2-D) digital photography used by DESW, whilst adequate for assessing diabetic retinopathy lesions, cannot determine the presence of diabetic macular oedema (increased retinal thickness). Current screening uses surrogate markers for suspecting the presence of maculopathy such as exudates within 1 disc diameter of the fovea or microaneurysms and haemorrhages with an unexplained visual acuity of 6/12 or worse. Diagnosing diabetic maculopathy requires a 3-D camera using OCT technology to determine whether treatment or monitoring is required. On OCT imaging, a substantial number with suspected diabetic maculopathy do not have maculopathy and are either dis-charged back to DESW or remain under monitoring for years in HES without ever having treatment.
Many HES departments experience lack of specialists and available space to cope with the ever-increasing patient numbers, which has led to significant delays in treatment and in some cases irreversible SSI. Therefore, there is a need to consider new ways of conducting ophthalmology services and to allocate certain elements into the primary care sector. Examples already exist such as the national Eye Health Examinations Wales (EHEW) service, and the national low Vision Service Wales. Increasingly, Health Boards are developing locally enhanced primary eye care pathways in partnership with the HES, such as Ophthalmic Diagnostic and Treatment Centres for glaucoma and age-related macular degeneration. In some parts of England, OCT surveillance clinics have been incorporated into diabetic eye screening, requiring additional funding. Currently, due to the increasing workload and Covid-19 related disruption, DESW cannot take on this extra work.
The Covid-19 pandemic made pre-existing pressures on the HES more evident and whilst services are returning to normal, the backlog and pressure from the numbers of new patients make it extremely difficult for the already stretched HES and DESW to continue seeing patients and to catch up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
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
- •People with diabetes referred to the hospital eye services for review of suspected diabetic maculopathy or pre-proliferative diabetic retinopathy in HDdUHB
排除标准
- •<18 years
- •People with diagnosed diabetic macular oedema
- •People with proliferative diabetic retinopathy
结局指标
主要结局
Time from referral to treatment
时间窗: From referral to the time of treatment at 6 months
Time taken from referral to ophthalmology to first treatment in ophthalmology
次要结局
- Time from referral to being seen(Time taken from enrollment ti first appointment within 3months)
- Prevalence(At baseline)
- Hospital to Community PREM questionnaire(Day 1)
- Total number of appointments in ophthalmology(through study completion, an average of 1 year)
- Travel distance from home to appointment(Through study completion, an average of 1 year)
- Costs associated with appointments(Through study completion, an average of 1 year)
