Clinical trial NCT06511700: Implementation of the Intravitreal Injection Administered by Nurses
Official title: Implementation of the Intravitreal Injection Service Administered by Nurses: Safety and Satisfaction of the Patients Served
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People who require intravitreal therapy in the ophthalmology service of the Corporation Parc Tauli

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.


Eligibility criteria: Inclusion criteria

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

Exclusion criteria

* 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

Primary outcomes:
measure: Complications presented during the IIV technique
timeFrame: In each injection during and after the procedure until the end of treatment
measure: Late post-procedure complications
timeFrame: In each injection during and after the procedure until the end of treatment
Secondary outcomes:
measure: Sociodemographic variables
timeFrame: At the beginning of treatment
measure: Date of treatment indication
timeFrame: At the beginning of treatment
measure: Ocular Diagnosis
timeFrame: At the beginning of treatment
measure: Ocular comorbidity
timeFrame: At the beginning of treatment
measure: Previous experience
timeFrame: At the beginning of treatment
measure: Companion
timeFrame: In each injection until the end of the treatment
measure: Visit to the ophthalmologist between therapies
timeFrame: In each injection until the end of the treatment
measure: Anxiety level
timeFrame: In each injection until the end of the treatment
measure: Treated eye
timeFrame: In each injection until the end of the treatment
measure: Ophthalmologist visit during the session
timeFrame: In each injection until the end of the treatment
measure: IVI Medication
timeFrame: In each injection until the end of the treatment
measure: Patient Pain
timeFrame: In each injection until the end of the treatment
measure: Patient Satisfaction
timeFrame: In each injection until the end of the treatment
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporation Parc Tauli
state: Barcelona
Study officials:
References: