The FENETRE study
Research type
Research Study
Full title
Quality-Assured Follow-up of quiEscent Neovascular agE-relaTed maculaR dEgeneration by non-medical practitioners: a randomised controlled trial The FENETRE study
IRAS ID
254025
Contact name
Konstantinos Balaskas
Contact email
Sponsor organisation
Moorfields Eye Hospital NHS Foundation Trust
ISRCTN Number
ISRCTN10447645
Clinicaltrials.gov Identifier
NCT03893474
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Neovascular Age-Related Macular Degeneration (nAMD) is a common vision threatening condition affecting mainly patients over the age of 65. At some point during follow-up the disease becomes inactive in many cases and does not need more injections. The risk of a flare-up is high, however, and patients need to continue to be seen every month for a significant period of time.
Hospital-based eye clinics are struggling to cope with current and expected workload for assessing and treating patients with nAMD. Transferring care of these patients to the community closer to home would ease the workload for hospital based clinics and offer a better experience of care to our patients.
In this study we will involve 742 patients with nAMD who have reached this inactive phase of the disease. Half of the patients that want to take part will continue to have their follow-up appointments in the hospital eye clinics as usual. The other half, chosen by chance, will have follow-up visits every month in a community optometrist practice by trained optometrists. The research team will provide the training for community optometrists.
The study will seek to show that the community based care is no less safe than hospital-based care.
We will also check what is the impact of this different way of offering care on the NHS budget and how the patients and practitioners perceive this. We will involve several hospital eye clinics across the country and several community optometrist practices. We will also hold meetings with patients to discuss their priorities and needs when looking at how to set up the community based eye clinics.
During meetings we had with patients in preparation for this research, they felt positively about the possibility to receive care closer to home.Lay summary of study results: Background Neovascular age-related macular degeneration (nAMD), a global leading cause of vision loss, typically requires long courses of intravitreal therapy while active, and regular monitoring during periods of quiescence (QnAMD). Currently, monitoring is hospital-based. Integrated‐care models redistributing chronic disease management between hospital and community settings have alleviated capacity pressures and maintained quality of care. Similarly, community optometry QnAMD monitoring, if safe, could broaden access and relieve pressures on ophthalmology services.
Methods
A multi-site non-inferiority RCT enrolled adults with QnAMD randomised 1:1 to monitoring by hospital eye services (control) or by accredited community optometrists (intervention) over 12 months. A structured, competency-based training programme of e-learning modules and expert-led webinars, followed by an accreditation test were completed by all participating community optometrists. At each visit, disease was classified as active or inactive (with a “suspicious” option in the community arm); active and suspicious cases triggered referral for hospital review. The primary outcome was the proportion of missed reactivations or new contralateral eye nAMD. A key secondary outcome was the rate of false-positive referrals.
Findings
Of 704 recruited participants, 635 completed follow-up (348 hospital, 287 community). Community optometrists had fewer missed reactivations (11/287 vs 27/348). False-positive referrals were higher in the community arm (24/287 vs 12/348).
Interpretation
Community-based QnAMD monitoring by trained optometrists is non-inferior to hospital monitoring for detecting reactivation, with an increase in unnecessary referrals that remained proportionately few. This approach may offer a transferable framework for evidence-generation in shared care clinical models, easing hospital demand and improving access without compromising safety.REC name
London - Bloomsbury Research Ethics Committee
REC reference
18/LO/2111
Date of REC Opinion
8 Feb 2019
REC opinion
Further Information Favourable Opinion