Intravitreal Injections by Nurses and Physicians Compared

Eye Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359149
• Other study ID #: 2014/1719
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: July 2019
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Eye Diseases

Intervention

Procedure:
• intravitreal injections given by a nurse

• intravitreal injections given by a physician

• Intravitreal injections

Drug:
• Anti-VEGF agents

Locations

Country	Name	City	State
Norway	St Olavs Hospital, Department of Ophthalmology	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View Citation

Bolme S, Morken TS, Follestad T, Sørensen TL, Austeng D. Task shifting of intraocular injections from physicians to nurses: a randomized single-masked noninferiority study. Acta Ophthalmol. 2019 Jul 3. doi: 10.1111/aos.14184. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in visual acuity	Mean change in visual acuity from baseline to 12 months, tested on ETDRS letter chart	1 year
Secondary	incidence of ocular adverse events		from baseline to 12 months
Secondary	patient satisfaction	questionnaire after the first treatment will be compared with questionnaire after 12 months	12 months