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Clinical Trials/NCT02359149
NCT02359149
Completed
Not Applicable

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

St. Olavs Hospital1 site in 1 country328 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Anti-VEGF agents
Conditions
Eye Diseases
Sponsor
St. Olavs Hospital
Enrollment
328
Locations
1
Primary Endpoint
change in visual acuity
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
March 31, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Arms & Interventions

physician

intravitreal injections with anti-VEGF agents given by a physician

Intervention: Anti-VEGF agents

nurse

intravitreal injections with anti-VEGF agents given by a nurse

Intervention: intravitreal injections given by a nurse

nurse

intravitreal injections with anti-VEGF agents given by a nurse

Intervention: Intravitreal injections

nurse

intravitreal injections with anti-VEGF agents given by a nurse

Intervention: Anti-VEGF agents

physician

intravitreal injections with anti-VEGF agents given by a physician

Intervention: intravitreal injections given by a physician

physician

intravitreal injections with anti-VEGF agents given by a physician

Intervention: Intravitreal injections

Outcomes

Primary Outcomes

change in visual acuity

Time Frame: 1 year

Mean change in visual acuity from baseline to 12 months, tested on ETDRS letter chart

Secondary Outcomes

  • incidence of ocular adverse events(from baseline to 12 months)
  • patient satisfaction(12 months)

Study Sites (1)

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