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

NCT06955611 | Recruiting

• 1 other identifier: 323048
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus; Diabetic Retinopathy; Diabetic Maculopathy

Keywords

Feasibility; Randomised Control Trial; OCT; Screening

Outcome Measures

Primary Outcomes (1)

• Time from referral to treatment

  Time taken from referral to ophthalmology to first treatment in ophthalmology

  From referral to the time of treatment at 6 months

Secondary Outcomes (6)

• 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

Study Arms (2)

Control

ACTIVE COMPARATOR

Usual care - Hospital eye service based monitoring with ophthalmologist

Other: Usual Care

Intervention

EXPERIMENTAL

Community based optometry OCT imaging with virtual review by ophthalmologist

Other: Community based optometry with Virtual Review

Interventions

Community based optometry with Virtual Review OTHER

Community based OCT imaging with optometrist and virtual review by ophthalmologist

Intervention

Usual Care OTHER

Hospital eye services review conducted by an ophthalmologist

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with diabetes referred to the hospital eye services for review of suspected diabetic maculopathy or pre-proliferative diabetic retinopathy in HDdUHB

You may not qualify if:

• \<18 years
• People with diagnosed diabetic macular oedema
• People with proliferative diabetic retinopathy

Sponsors & Collaborators

• Hywel Dda Health Board: lead
• Swansea University: collaborator

Study Sites (1)

Hwyel Dda University Health Board

Haverfordwest, SA61 2PZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Study Officials

• Eirini Skiadaresi, MD

  Hywel Dda University Health Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

abigail Taylor

CONTACT

01437773823; abigail.taylor@wales.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: May 2, 2025
• Study Start: November 20, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)