NCT02359149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

2.1 years

First QC Date

February 4, 2015

Last Update Submit

July 4, 2019

Conditions

Eye Diseases

Keywords

Intravitreal injectionsNursesPhysicians

Outcome Measures

Primary Outcomes (1)

  • change in visual acuity

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

    1 year

Secondary Outcomes (2)

  • incidence of ocular adverse events

    from baseline to 12 months

  • patient satisfaction

    12 months

Study Arms (2)

nurse

EXPERIMENTAL

intravitreal injections with anti-VEGF agents given by a nurse

Procedure: intravitreal injections given by a nurseProcedure: Intravitreal injectionsDrug: Anti-VEGF agents

physician

ACTIVE COMPARATOR

intravitreal injections with anti-VEGF agents given by a physician

Procedure: intravitreal injections given by a physicianProcedure: Intravitreal injectionsDrug: Anti-VEGF agents

Interventions

intravitreal injections given by a nursePROCEDURE
nurse
intravitreal injections given by a physicianPROCEDURE
physician
Intravitreal injectionsPROCEDURE
nursephysician
Anti-VEGF agentsDRUG
Also known as: anti vasculer endothelial growth factor
nursephysician

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital, Department of Ophthalmology

Trondheim, Norway

Location

Related Publications (3)

  • Austeng D, Morken TS, Bolme S, Follestad T, Halsteinli V. Nurse-administered intravitreal injections of anti-VEGF: study protocol for noninferiority randomized controlled trial of safety, cost and patient satisfaction. BMC Ophthalmol. 2016 Oct 1;16(1):169. doi: 10.1186/s12886-016-0348-4.

    PMID: 27716253BACKGROUND

  • Bolme S, Morken TS, Follestad T, Sorensen TL, Austeng D. Task shifting of intraocular injections from physicians to nurses: a randomized single-masked noninferiority study. Acta Ophthalmol. 2020 Mar;98(2):139-144. doi: 10.1111/aos.14184. Epub 2019 Jul 3.

    PMID: 31267688RESULT

  • Bolme S, Austeng D, Morken TS, Follestad T, Halsteinli V. Cost consequences of task-shifting intravitreal injections from physicians to nurses in a tertiary hospital in Norway. BMC Health Serv Res. 2023 Mar 8;23(1):229. doi: 10.1186/s12913-023-09186-0.

    PMID: 36890535DERIVED

MeSH Terms

Conditions

Eye Diseases

Interventions

Intravitreal Injections

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Marit Fagerli, md

    St. Olavs University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 9, 2015

Study Start

March 1, 2015

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)