Intravitreal Injections by Nurses and Physicians Compared

Not Applicable

Completed

• Conditions: Eye Diseases
• Interventions: Procedure: intravitreal injections given by a nurse; Procedure: intravitreal injections given by a physician; Procedure: Intravitreal injections; Drug: Anti-VEGF agents

• Registration Number: NCT02359149
• Lead Sponsor: St. Olavs Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-09
• Study Start: 2015-03
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nurse	intravitreal injections given by a nurse	intravitreal injections with anti-VEGF agents given by a nurse
physician	Anti-VEGF agents	intravitreal injections with anti-VEGF agents given by a physician
physician	Intravitreal injections	intravitreal injections with anti-VEGF agents given by a physician
physician	intravitreal injections given by a physician	intravitreal injections with anti-VEGF agents given by a physician
nurse	Intravitreal injections	intravitreal injections with anti-VEGF agents given by a nurse
nurse	Anti-VEGF agents	intravitreal injections with anti-VEGF agents given by a nurse

Primary Outcome Measures

Name	Time	Method
change in visual acuity	1 year	Mean change in visual acuity from baseline to 12 months, tested on ETDRS letter chart

Secondary Outcome Measures

Name	Time	Method
incidence of ocular adverse events	from baseline to 12 months
patient satisfaction	12 months	questionnaire after the first treatment will be compared with questionnaire after 12 months

Trial Locations

Locations (1)

St Olavs Hospital, Department of Ophthalmology; 🇳🇴 Trondheim, Norway