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Implementation of the Intravitreal Injection Administered by Nurses

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record status
This record was last updated March 24, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Enrollment target: 400 to 200
    • Start date changed from estimate of Sep 10, 2024 to Jan 15, 2025
    • Site contact updated
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06511700
Lead Sponsor Corporacion Parc Tauli
Conditions
(from sponsor)
Macular Edema, Macular Degeneration, Diabetic Macular Edema
Related terms Macular Degeneration, Macular Edema, Retinal Vein Occlusion
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov