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NCT06511700Enrolling by invitation

Implementation of the Intravitreal Injection Administered by Nurses

Implementation of the Intravitreal Injection Service Administered by Nurses: Safety and Satisfaction of the Patients Served

Source: ClinicalTrials.gov · Last updated 24 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
200 (estimated)
First submitted
3 Jul 2024
Start date
15 Jan 2025
Primary completion date
30 Dec 2025
Lead sponsor
Corporacion Parc Tauli
NCT number
NCT06511700

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 15 Jan 2025 to the primary completion date, 30 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • With intravitreal steroid implant.

Other illness

  • 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.

Other

  • Non-collaborators in the technique for physical, psychological or nystagmus reasons.
  • Pregnant women: Due to the potential teratogenic effect of anti-FCEV

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Corporation Parc Tauli
Coordinator of this site? Confirm its status
SabadellSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.