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UnknownNCT03893474

Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners

Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners: a Randomised Controlled Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
742 (estimated)
Sponsor
Moorfields Eye Hospital NHS Foundation Trust · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

This is a prospective, randomised, multi-site clinical trial testing the non-inferiority of community optometry follow-up of participants with QnAMD over 12 months

Detailed description

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 patients. This study will recruit 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. The study 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. The study will involve several hospital eye clinics across the country and several community optometrist practices. Meetings will also be held with patients to discuss their priorities and needs when looking at how to set up the community based eye clinics. During meetings with patients in preparation for this research, they felt positively about the possibility to receive care closer to home.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTOCTOptical Coherence Tomography of study eye.
DIAGNOSTIC_TESTVisual AcuityVisual acuity measured by ETDRS

Timeline

Start date
2019-09-30
Primary completion
2022-05-01
Completion
2022-11-01
First posted
2019-03-28
Last updated
2021-09-17

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03893474. Inclusion in this directory is not an endorsement.