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RECRUITINGINTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - People with diabetes referred to the hospital eye services for review of suspected diabetic maculopathy or pre-proliferative diabetic retinopathy in HDdUHB Who Should NOT Join This Trial: - \<18 years - People with diagnosed diabetic macular oedema - People with proliferative diabetic retinopathy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * People with diabetes referred to the hospital eye services for review of suspected diabetic maculopathy or pre-proliferative diabetic retinopathy in HDdUHB Exclusion Criteria: * \<18 years * People with diagnosed diabetic macular oedema * People with proliferative diabetic retinopathy

Treatments Being Tested

OTHER

Community based optometry with Virtual Review

Community based OCT imaging with optometrist and virtual review by ophthalmologist

OTHER

Usual Care

Hospital eye services review conducted by an ophthalmologist

Locations (1)

Hwyel Dda University Health Board
Haverfordwest, United Kingdom