Intravitreal Injections by Nurses and Physicians Compared

Study Overview
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Brief Summary
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Anti-VEGF agents are given for a variety of previously untreatable eye diseases. The last years indications for their use and consequently the number of patients needing treatment, have been increasing. Most patients require multiple injections. This has resulted in many eye departments administering thousands of injections per year, also at St Olavs University Hospital Trondheim. To cope with this increase in workload, it would be helpful if injections would be given not only by the physicians but also by the nurses. This study's objective is to compare efficiency, patient satisfaction and cost per patient of injections given by nurses and physicians.

Official Title
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Intravitreal Injections by Nurses or Physicians: a Randomized Controlled Trial Comparing Efficacy, Patient Satisfaction and Health Economy

Conditions
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Eye Diseases

Intervention / Treatment
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* Procedure: intravitreal injections given by a nurse
* Procedure: intravitreal injections given by a physician
* Procedure: Intravitreal injections
* Drug: Anti-VEGF agents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referred to the eye clinic for treatment of age related macular degeneration, diabetes retinopathy or retinal vein occlusion with anti-vascular endothelium growth factor Ability to provide written informed consent ability to comply with study assessments for the full duration of the study Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nurse<br>intravitreal injections with anti-VEGF agents given by a nurse | Procedure: intravitreal injections given by a nurse<br> <br> Procedure: Intravitreal injections<br> <br> Drug: Anti-VEGF agents<br> <br> * Other names: anti vasculer endothelial growth factor;|
| Active Comparator: physician<br>intravitreal injections with anti-VEGF agents given by a physician | Procedure: intravitreal injections given by a physician<br> <br> Procedure: Intravitreal injections<br> <br> Drug: Anti-VEGF agents<br> <br> * Other names: anti vasculer endothelial growth factor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in visual acuity | Mean change in visual acuity from baseline to 12 months, tested on ETDRS letter chart | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of ocular adverse events |  | from baseline to 12 months | 
| patient satisfaction | questionnaire after the first treatment will be compared with questionnaire after 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravitreal injections, Nurses, Physicians