Eye DiseasesNCT02359149
Intravitreal Injections by Nurses and Physicians Compared
A study testing intravitreal injections given by a nurse, intravitreal injections given by a physician and Intravitreal injections in people with Eye Diseases, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eye Diseases
- What is being tested?
- intravitreal injections given by a nurse, intravitreal injections given by a physician and Intravitreal injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2015to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravitreal Injections by Nurses or Physicians: a Randomized Controlled Trial Comparing Efficacy, Patient Satisfaction and Health Economy
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.
- Conditions
- Eye Diseases
- Being tested
- intravitreal injections given by a nurse, intravitreal injections given by a physician, Intravitreal injections, Anti-VEGF agents
- Keywords
- Intravitreal injections, Nurses, Physicians
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injections given by a nurseProcedure or surgery
intravitreal injections given by a physicianProcedure or surgery
Intravitreal injectionsProcedure or surgery
Anti-VEGF agentsDrug
Also called anti vasculer endothelial growth factor
| Study group | Role | What they receive |
|---|---|---|
| nurse | Experimental | intravitreal injections with anti-VEGF agents given by a nurse Receives: Procedure: intravitreal injections given by a nurse; Procedure: Intravitreal injections; Drug: Anti-VEGF agents |
| physician | Active comparator | intravitreal injections with anti-VEGF agents given by a physician Receives: Procedure: intravitreal injections given by a physician; Procedure: Intravitreal injections; Drug: Anti-VEGF agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in visual acuity
Mean change in visual acuity from baseline to 12 months, tested on ETDRS letter chart
Measured: 1 year
Secondary outcomes (2)
incidence of ocular adverse events
Measured: from baseline to 12 months
patient satisfaction
questionnaire after the first treatment will be compared with questionnaire after 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startMar 2015
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Marit Fagerli, md, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359149
- Sponsor's protocol ID
- 2014/1719
- Status last verified
- Jul 2019
- First submitted
- 4 Feb 2015
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27716253Bolme 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.
PubMed 31267688Bolme 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.
PubMed 36890535
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Injections by Nurses or Physicians: a Randomized Controlled Trial Comparing Efficacy, Patient Satisfaction and Health Economy
- ClinicalTrials.gov ID
- NCT02359149
- Acronym / sponsor ID
- 2014/1719
- Conditions
- Eye Diseases
- Keywords
- Intravitreal injections, Nurses, Physicians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Mar 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nurse | Experimental | Procedure: intravitreal injections given by a nurse, Procedure: Intravitreal injections, Drug: Anti-VEGF agentsintravitreal injections with anti-VEGF agents given by a nurse |
| physician | Active comparator | Procedure: intravitreal injections given by a physician, Procedure: Intravitreal injections, Drug: Anti-VEGF agentsintravitreal injections with anti-VEGF agents given by a physician |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravitreal injections given by a nurse | Procedure or surgery | nurse |
| intravitreal injections given by a physician | Procedure or surgery | physician |
| Intravitreal injections | Procedure or surgery | nurse, physician |
| Anti-VEGF agentsAlso: anti vasculer endothelial growth factor | Drug | nurse, physician |
Primary outcome
change in visual acuity
Time frame: 1 year
Mean change in visual acuity from baseline to 12 months, tested on ETDRS letter chart
2 secondary outcomes
incidence of ocular adverse events
Time frame: from baseline to 12 months
patient satisfaction
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Background: PubMed 27716253Austeng 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 publication: PubMed 31267688Bolme 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.
- Derived from this study: PubMed 36890535Bolme 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marit Fagerli, md study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravitreal injections given by a nurse, intravitreal injections given by a physician and Intravitreal injections in people with Eye Diseases, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in visual acuity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02359149, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.