Implementation of the Intravitreal Injection Administered by Nurses

NCT06511700 | Enrolling By Invitation

• 1 other identifier: Intravitrial-injection2024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Intravitreal injections involve medication administration into the eye to treat ocular diseases and protect vision. Through an injection, the medication is introduced into the vitreous cavity, an area located at the back of the eye, behind the lens. The intravitreal injection (IVI) is a minimally invasive process administered at personalized regular intervals. It is a common procedure in ophthalmology for patients who require it. International experiences demonstrate that administering intravitreal injections, especially by nurses trained in aseptic techniques, is feasible without compromising patient safety. The project presented is based on a new care model rooted in interdisciplinary collaboration in the IVI process, operationalizing it as a functional unit. This is a great opportunity to expand the scope of practice for nurses and to demonstrate, as has been done in other countries, that the same procedure currently performed by ophthalmologists can be carried out with equal safety. Objective: To evaluate the safety of implementing a program incorporating nurses trained in administering intravitreal injections within the functional unit of Ophthalmology at Corporation Parc Tauli. Method: Observational evaluation study of a care process within the functional Ophthalmology Unit, consisting of protocol application for intravitreal injection by trained nurses. Data will be collected from users receiving care from the intravitreal injection service administered by nurses under a consensual procedure within the unit. Users meeting the inclusion criteria will be eligible. Nurses will be trained internally at CCSPT by the ophthalmology team. User participation will be voluntary. Informed consent will be obtained. Data collection during the process of care will include recording selected variables. Data collection will be carried out between 2024 and 2025. The study will be conducted over 3 years. Application and Impact: The development of this project will allow for a safe, more efficient redistribution of our resources. The functional unit is based on a group of professionals who work and make decisions jointly. The new distribution will enable ophthalmologists to expand their availability for more complex procedures. In the future, it is expected to increase the number of users who can benefit from the IVI service and to initiate advanced competencies in the role of the ophthalmology nurse.

Conditions

Macular Edema; Macular Degeneration; Diabetic Macular Edema

Keywords

Anti-VEGF; Intravitreal injection; Nurse; Age-related macular degeneration; Retinal vein occlusion; Diabetic macular edema; safety

Outcome Measures

Primary Outcomes (2)

• Complications presented during the IIV technique

  Complications presented during IIV 1.1 Pain from the placement of the blepharostat: It will be recorded as: 0=No ; 1=Yes 1.2 Pain during the injection: It will be recorded as: 0=No ; 1=Yes 1.3 Subconjunctival haemorrhage. It will be recorded as: 0=No ; 1=Yes 1.4 Post-injection ocular hypertension: It will be recorded as: 0=No ; 1=Yes 1.5 Other Complications (specified with free text)

  In each injection during and after the procedure until the end of treatment

• Late post-procedure complications

  Complications that arise when users leave the service. In this case, users will be asked in subsequent visits about the complications presented. They can also be reviewed from the patient's medical history. 2.1. Pain: If pain appeared in the first 48h. It will be recorded using a Likert scale from 0 to 10, where 0 is no pain and 10 maximum pain. 2.2 Subconjunctival haemorrhage: It will be recorded as: 0=No ; 1=Yes 2.3. Ocular hypertension: It will be recorded as: 0=No ; 1=Yes 2.4. Visual ability to perform AVDs: To assess the current state of their vision, we will be asked if they currently notice that they can do their usual activities better or not. It will be recorded as: 0= Worsening ; 1= Maintenance; 2= Improvement 2.5. Visit to the emergency room (or ophthalmology service) for problems after the IIV. It will be recorded as: 0=No ; 1=Yes, and free text that answer to what problem did they present.

  In each injection during and after the procedure until the end of treatment

Secondary Outcomes (13)

• Sociodemographic variables

  At the beginning of treatment

• Date of treatment indication

  At the beginning of treatment

• Ocular Diagnosis

  At the beginning of treatment

• Ocular comorbidity

  At the beginning of treatment

• Previous experience

  At the beginning of treatment

Interventions

It is a implementation a program incorporating nurses trained in administering intravitreal injections within the functional unit of Ophthalmology following the usual technique PROCEDURE

Internationally, some experiences demonstrate that the administration of intravitreal injections, especially by nurses trained in aseptic techniques, is feasible without compromising patient safety. Although there is already some experience in Spain, it is a new procedure within the nursing field of the Ophthalmology service for which no results have been reported.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People who require intravitreal therapy in the ophthalmology service of the Corporation Parc Tauli

You may qualify if:

• \- People over 18 years of age who require intravitreal therapy in the ophthalmology service

You may not qualify if:

• Non-collaborators in the technique for physical, psychological or nystagmus reasons.
• Have recent evidence of blepharitis or conjunctivitis ≤15 days (ex, red eye or thick discharge) to avoid the risk of introducing infection into the eyeball.
• Suffer ischemic heart disease or recent stroke ≤3 months to avoid the risk of precipitating another vascular ischemic attack.
• With intravitreal steroid implant.
• Pregnant women: Due to the potential teratogenic effect of anti-FCEV

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Corporation Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Macular Edema; Macular Degeneration; Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse, Phd Health of Science

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 22, 2024
• Study Start: January 15, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

ES (1)