[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hywel Dda Health Board\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100589530","is-community-based-monitoring-of-diabetic-maculopathy-and-pre-proliferative-diabetic-retinopathy-safe-100589530",false,"NCT06955611","Is Community Based Monitoring of Diabetic Maculopathy and Pre-proliferative Diabetic Retinopathy Safe?","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)","FARSight-DM","Inclusion Criteria:\n\n* People with diabetes referred to the hospital eye services for review of suspected diabetic maculopathy or pre-proliferative diabetic retinopathy in HDdUHB\n\nExclusion Criteria:\n\n* \\\u003C18 years\n* People with diagnosed diabetic macular oedema\n* People with proliferative diabetic retinopathy",true,"ALL","18 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"NA","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?\n\nScreening 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.\n\nDiagnosing 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.\n\nCurrently 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.\n\nThe 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.",[28,29,30],"Diabetes Mellitus","Diabetic Retinopathy","Diabetic Maculopathy",[32,33,34,35],"Feasibility","Randomised Control Trial","OCT","Screening","RECRUITING","2025-04-24",{"date":39,"type":40},"2025-05-02","ACTUAL",{"date":42,"type":40},"2024-11-20",{"date":44,"type":22},"2025-09",{"name":46,"class":47},"Hywel Dda Health Board","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100586392","investigating-the-metabolic-and-lipidomic-profiles-that-are-associated-with-varying-grades-of-diabetic-maculopathy-and-retinopathy-in-south-wales-100586392","NCT06914778","Investigating the Metabolic and Lipidomic Profiles That Are Associated With Varying Grades of Diabetic Maculopathy and Retinopathy in South Wales","IMLADRIS","Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus\n* Male or female aged 18 - 80 inclusive\n\nExclusion Criteria:\n\n* Participant unable or unwilling to consent to inclusion in the study\n* Prior treatment with intravitreal therapies for DMO\n* Potential participant with a known infective disease that may put the study team at risk (eg. TB, HIV, hepatitis)\n* Age 17 yo or less or 81 yo or older\n* Known underlying genetic condition affecting lipid metabolism","80 Years",{"count":58,"type":22},120,"OBSERVATIONAL","Diabetes mellitus is a disorder of sugar and fat metabolism which results in damage to the small blood vessels in various organs, this includes the retina - the part of the eye that processes light into a nerve impulse. This leads to damage and blindness via various different mechanisms that are not fully understood.\n\nIn this study the objective is to recruit people with diabetes and various stages of diabetic eye disease and measure a large number of different chemicals within the blood that might be associated with damage and dysfunction within the retina. Additionally, it will examine the different bacteria within the gut that might affect disease in the eye via chemicals circulating in the blood. This will require participants to have blood samples taken and to provide urine samples. The blood will be analysed with specialised instruments to identify specific molecules circulating within the blood. Participants will also need to allow researchers to look at their medical records, previous photographs and specialist scans of the back of the eye to grade their diabetic retinopathy. This will allow us to identify potential ways in which these could be targeted for future benefit for people with diabetes to hopefully prevent deterioration of their vision.",[62,63,64],"Diabetic Retinopathy (DR)","Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus","Diabetic Macular Edema (DME)",[66,67,68,69,70],"diabetic retinopathy","lipidomics","ophthalmology","diabetic maculopathy","metabolomics","2025-04-08",{"date":73,"type":40},"2025-04-10",{"date":75,"type":40},"2025-03-31",{"date":77,"type":22},"2030-01-01",{"name":46,"class":47},""]