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Intravitreal Injections by Nurses and Physicians Compared

Primary Purpose

Eye Diseases

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

intravitreal injections given by a nurse

intravitreal injections given by a physician

Intravitreal injections

Anti-VEGF agents

About this trial

This is an interventional supportive care trial for Eye Diseases focused on measuring Intravitreal injections, Nurses, Physicians

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

St Olavs Hospital, Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nurse

physician

Arm Description

intravitreal injections with anti-VEGF agents given by a nurse

intravitreal injections with anti-VEGF agents given by a physician

Outcomes

Primary Outcome Measures

change in visual acuity

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

Secondary Outcome Measures

incidence of ocular adverse events

patient satisfaction

questionnaire after the first treatment will be compared with questionnaire after 12 months

Full Information

NCT ID

NCT02359149

First Posted

February 4, 2015

Last Updated

July 4, 2019

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT02359149

Brief Title

Intravitreal Injections by Nurses and Physicians Compared

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

March 2015 (Actual)

Primary Completion Date

March 31, 2017 (Actual)

Study Completion Date

March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eye Diseases

Keywords

Intravitreal injections, Nurses, Physicians

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

328 (Actual)

8. Arms, Groups, and Interventions

Arm Title

nurse

Arm Type

Experimental

Arm Description

intravitreal injections with anti-VEGF agents given by a nurse

Arm Title

physician

Arm Type

Active Comparator

Arm Description

intravitreal injections with anti-VEGF agents given by a physician

Intervention Type

Procedure

Intervention Name(s)

intravitreal injections given by a nurse

Intervention Type

Procedure

Intervention Name(s)

intravitreal injections given by a physician

Intervention Type

Procedure

Intervention Name(s)

Intravitreal injections

Intervention Type

Drug

Intervention Name(s)

Anti-VEGF agents

Other Intervention Name(s)

anti vasculer endothelial growth factor

Primary Outcome Measure Information:

Title

change in visual acuity

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

incidence of ocular adverse events

Time Frame

from baseline to 12 months

Title

patient satisfaction

Description

questionnaire after the first treatment will be compared with questionnaire after 12 months

Time Frame

12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marit Fagerli, md

Organizational Affiliation

St Olavs University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

St Olavs Hospital, Department of Ophthalmology

City

Trondheim

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27716253

Citation

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.

Results Reference

background

PubMed Identifier

31267688

Citation

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.

Results Reference

result

Learn more about this trial

Intravitreal Injections by Nurses and Physicians Compared

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