Nurse-administered intravitreal injections of anti-VEGF: study protocol for noninferiority randomized controlled trial of safety, cost and patient satisfaction.

BACKGROUND: Intravitreal injections (IVI) of anti-vascular endothelial growth factor (anti-VEGF) now improve or stabilize visual acuity in a number of previously untreatable eye diseases, of which the main are age-related macular degeneration, retinal vein occlusion and diabetic macular edema. Most patients require multiple injections over lengthy periods of time and the prevalence of treatable conditions is increasing. Anti-VEGF IVI normally administered by physicians, therefore represent a considerable workload on ophthalmologic clinics and will continue to do so in the near future. Nurse-administered IVI may relieve this workload, but the safety, cost and patient satisfaction of such an extended role for nurses in ophthalmologic clinics has not earlier been investigated. To investigate these outcomes following independent anti-VEGF IVI by trained nurses, a noninferiority randomized controlled trial is being conducted. METHODS/DESIGN: Patients eligible for anti-VEGF treatment, minimum 304, are recruited and randomized to IVI administration by either trained nurses or physicians. The primary outcome is safety, measured by difference in mean change in visual acuity between the two groups during an observation period of 12 months. Secondary outcomes are incidence of ocular adverse events, cost per patient and patient satisfaction. DISCUSSION: This study protocol describes the design of the first randomized controlled trial of nurse-administered IVI of anti-VEGF. The study is designed to examine safety, cost and patient satisfaction during 12 months follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT02359149 . Registered February 4, 2015.

Nurse specialists for the administration of anti-vascular endothelial growth factor intravitreal injections.

AIM: The number of individuals with chronic conditions such as age-related macular degeneration (AMD) is increasing, and consequently the treatment burden for anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections is also increasing. The use of nurse specialists to administer anti-VEGF intravitreal injections has been proposed to address this treatment burden. This was a prospective safety audit to determine the safety of nurse specialists for the delivery of anti-VEGF intravitreal injections. METHOD: A prospective safety audit was undertaken for a nurse specialist-delivered injection service in the Ophthalmology Clinic, Greenlane Clinical Centre. The department's senior medical retinal consultant supervised the nurse specialist training programme. The clinical safety of anti-VEGF intravitreal injections delivered by nurse specialists, and the impact of this programme on clinical capacity at our Institute was reviewed. RESULTS: The nurse specialists administered a total of 2,900 injections over an 18-month period. Two patients developed endophthalmitis post injection (1 infective, 1 non-infective). Two patients had a vitreous haemorrhage, and five patients had raised intraocular pressure. The incidence of post-injection endophthalmitis, vitreous haemorrhage and raised intraocular pressure was 0.07%, 0.07% and 0.17%, respectively. CONCLUSION: The nurse specialist-delivered injection service is a safe and effective service for treatment of wet AMD, diabetic macular oedema and vein occlusion.

Non-physician delivered intravitreal injection service is feasible and safe - a systematic review.

INTRODUCTION: Non-physicians such as nurses are trained to give injections into the vitreous body of the eye to meet the increasing demand for intravitreal therapy with vascular endothelial growth factor inhibitors against common eye diseases, e.g. age-related macular degeneration and diabetic retinopathy. We systematically reviewed the existing literature to provide an overview of the experiences in this transformational process. METHODS: We searched for literature on 22 September 2015 using PubMed, Embase, the Cochrane Library, CINAHL and the Web of Science. Eligible studies had to address any outcome based on non-physician delivered intravitreal therapy regardless of the study design. Being non-physician was defined as the injecting personnel not being a physician, but no further restrictions were made. RESULTS: Five studies were included with a total of 31,303 injections having been performed by 16 nurses. The studies found that having nurses perform the intravitreal injections produced to a short-term capacity improvement and liberated physicians for other clinical work. Training was provided through courses and direct supervision. The rates of endophthalmitis were 0-0.40‰, which is comparable to reported rates when the intravitreal therapy is given by physicians. CONCLUSION: Non-physician delivered intravitreal therapy seems feasible and safe.