RecruitingNAINTERVENTIONAL

Is Community Based Monitoring of Diabetic Maculopathy and Pre-proliferative Diabetic Retinopathy Safe?

This study is investigating a new way to check for eye problems like diabetic maculopathy, which can be caused by diabetes. Instead of always going to the hospital, trained opticians in local practices will use special 3D cameras to take pictures of your eye. These pictures will then be reviewed by a hospital eye doctor online. The research wants to see if this new approach is safe, works well, and is acceptable to people with diabetes. It could make eye checks more convenient for you, reduce pressure on hospital eye clinics, and help use NHS resources more efficiently. The goal is to improve how we care for diabetic eye conditions.

At a glance

Status

Recruiting

Phase

Sponsor

Hywel Dda Health Board

Enrolment target

150

Start

20 Nov 2024

Estimated completion

01 Sep 2025

Diabetes Mellitus Diabetic Retinopathy Diabetic Maculopathy

What is this study about?

Diabetes can sometimes affect your eyes, leading to conditions like diabetic retinopathy and diabetic maculopathy. These can cause blurry vision or even loss of sight if not caught and treated early. Currently, routine eye checks for diabetes in Wales involve taking 2D pictures of the back of your eye. However, a specific problem called maculopathy, which is swelling at the very centre of your vision, can't always be seen clearly with these 2D pictures.

To properly diagnose maculopathy, a special 3D scan called an OCT (Optical Coherence Tomography) is needed. Right now, if your 2D scan suggests a possible problem, you're usually sent to a hospital eye clinic for this 3D scan. Many people who go to the hospital for this still don't have maculopathy that needs treatment, meaning their hospital appointment could have been used by someone else who really needed it.

This study is testing a new way of doing things. It involves trained opticians, who already have OCT cameras in their local practices, doing these 3D scans and initial checks. These scans and your records would then be sent electronically to a hospital eye doctor for them to review from the hospital. The doctor would then decide on the best plan for you. The study wants to find out if this new system is safe, helps people get checked closer to home, and is a good use of NHS resources.

Key takeaways

Tests a new way to check for diabetic eye problems using local opticians.
Aims to make eye care more convenient and closer to your home.
Special 3D scans (OCT) would be taken by opticians, then reviewed by hospital doctors.
Could help reduce pressure on hospital eye clinics.
Focuses on safety and effectiveness for people with diabetes.
This study evaluates a process, not a new medicine or treatment.

Who may be eligible?

To join this study, you must have diabetes and have been referred to the hospital eye services because doctors suspect you might have diabetic maculopathy or a type of diabetic retinopathy called pre-proliferative diabetic retinopathy.

However, you cannot take part if you are under 18 years old. Also, if you have already been diagnosed with diabetic macular oedema (another name for diabetic maculopathy) or a more advanced form of diabetic retinopathy called proliferative diabetic retinopathy, this study won't be suitable for you.

Quick self-check

Do I have diabetes?
Have I been referred to hospital eye services for suspected diabetic maculopathy or pre-proliferative diabetic retinopathy?
Am I 18 years old or older?
Have I NOT already been diagnosed with diabetic macular oedema?
Have I NOT already been diagnosed with proliferative diabetic retinopathy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The description does not provide specific details on participation, such as the number of visits, assessments, or overall duration for those taking part in the study. It focuses on the new 'pathway' being investigated rather than the participant journey within the study itself.

Potential risks and benefits

This study aims to find a more convenient and efficient way for you to receive care for your diabetic eye condition, potentially reducing hospital visits and allowing you to be seen closer to home. There are no direct medical benefits to participating in this research as it is evaluating a process rather than a new treatment. The study is particularly interested in whether this new pathway is safe; trained professionals will be involved in every step to ensure your eye health is carefully monitored. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Hwyel Dda University Health Board
Haverfordwest, United Kingdom· Recruiting

Common questions

What is diabetic maculopathy?

It's swelling in the central part of the retina at the back of your eye, caused by diabetes, which can affect your detailed vision.

What is an OCT scan?

It's a special 3D camera that creates detailed pictures of the layers inside your eye, helping doctors see problems like swelling that 2D pictures might miss.

Why are opticians involved?

Many opticians already have the special OCT cameras, and training them to do the initial checks could make eye care more accessible and ease the burden on hospitals.

Will my hospital doctor still be involved?

Yes, once the optician takes the scans, a hospital eye doctor will review them online and decide on the best next steps for your care.

Could this mean fewer hospital visits for me?

That's one of the main goals of this study – to see if this new pathway can reduce the need for hospital trips for initial assessments.

How to find out more

abigail Taylor

abigail.taylor@wales.nhs.uk 01437773823 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.