Macular EdemaNCT06511700
Implementation of the Intravitreal Injection Administered by Nurses
An observational study of Macular Edema and Macular Degeneration, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Macular Degeneration, Diabetic Macular Edema
- What is being tested?
- It is a implementation a program incorporating nurses trained in administering intravitreal injections within the functional unit of Ophthalmology following the usual technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: People who require intravitreal therapy in the ophthalmology service of the Corporation Parc Tauli
Who may be able to join
- People over 18 years of age who require intravitreal therapy in the ophthalmology service
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementation of the Intravitreal Injection Service Administered by Nurses: Safety and Satisfaction of the Patients Served
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.
Read more
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
- Being tested
- It is a implementation a program incorporating nurses trained in administering intravitreal injections within the functional unit of Ophthalmology following the usual technique
- Keywords
- Anti-VEGF, Intravitreal injection, Nurse, Age-related macular degeneration, Retinal vein occlusion, Diabetic macular edema, safety
- Medical subject headings
- Macular Edema, Macular Degeneration, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
It is a implementation a program incorporating nurses trained in administering intravitreal injections within the functional unit of Ophthalmology following the usual techniqueProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: In each injection during and after the procedure until the end of treatment
Secondary outcomes (13)
Sociodemographic variables
Years old, gender, family coexistence
Measured: At the beginning of treatment
Date of treatment indication
This is the date the procedure was indicated. It will be recorded as YYYY/MM/DD
Measured: At the beginning of treatment
Ocular Diagnosis
The main diagnosis that makes IIV indicated. It will be recorded as free text.
Measured: At the beginning of treatment
Ocular comorbidity
Presence of another associated eye pathologies. It will be recorded as free text.
Measured: At the beginning of treatment
Previous experience
We will ask if the patient had received IIV therapy from an ophthalmologist some time ago. If so, it don't need to ask again.
It will be recorded as: 0= No; 1=Yes
Measured: At the beginning of treatment
Companion
Family presence at the session. It will be recorded as: 0= alone; 1=Accompanied
Measured: In each injection until the end of the treatment
Visit to the ophthalmologist between therapies
Inquiry about the patient's visit ophthalmologist between IIV sessions. Cycles of a specific number of sessions are usually scheduled and then they are visited at the ophthalmology consultation to review the effectiveness and maintenance of the treatment, being able to change the type of drug.
It will be recorded as: 0=No; 1=Yes
Measured: In each injection until the end of the treatment
Anxiety level
Anxiety presented before the procedure. It will be evaluated using a Likert scale from 0 to 10, where 0 is minimum anxiety and 10 maximum anxiety.
Measured: In each injection until the end of the treatment
Treated eye
Registration of the eye that receiving the IIV: 0=right, 1=left, 2=both.
Measured: In each injection until the end of the treatment
Ophthalmologist visit during the session
The responsible ophthalmologist must be available during IIV session for any questions that may arise.
If any query has to be made it will be recorded: 0=No; =Yes. If so, the reason must be specified (free text).
Measured: In each injection until the end of the treatment
IVI Medication
Record of intravitreal medication administered. Record: 1 = Aflibercept (EYLEA®) ; 2= Bevacizumab (AVASTIN®); 3= Ranibizumab (LUCENTIS®); 4=Intravitreal Dexamethasone (OZURDEX®) 5= Others (specify). Drugs 1, 2 and 3 are drugs that inhibit vascular endothelial growth factor (anti-VEGF) and will be the two that will initially begin IIV for the nurses. On the 4th, for the present presentation and special administrative provision, initially excluded from being administered by nursing, it will be administered in three sessions by ophthalmologists.
During 2024, the addition of a new Anti-FEVG to the CCSPT, Faricimab (VABYSMO®), is planned, which is expected to be important from a quantitative point of view in the total IIV.
Measured: In each injection until the end of the treatment
Patient Pain
Pain that is present during IIV. It will be recorded using a Likert scale from 0 to 10, 0 no pain and 10 the most pain.
Measured: In each injection until the end of the treatment
Patient Satisfaction
No validated questionnaire has been found in the literature to assess patient satisfaction with intravitreal therapy. Therefore, the criteria used by the study by Austen et al will be used in the consultation.
They developed a simple satisfaction questionnaire in accordance with the guidelines for measuring the quality of health services. It consists of 2 questions with a Likert scale from 1 to 5, one related to satisfaction and the other to trust.
In the case of answering with a low score, they are accompanied by a clarification question to improve these aspects (free text).
Measured: In each injection until the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start15 Jan 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susana Santos-Ruiz, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511700
- Sponsor's protocol ID
- Intravitrial-injection2024
- Status last verified
- Mar 2025
- First submitted
- 3 Jul 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Intravitreal Injection Service Administered by Nurses: Safety and Satisfaction of the Patients Served
- ClinicalTrials.gov ID
- NCT06511700
- Acronym / sponsor ID
- Intravitrial-injection2024
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People who require intravitreal therapy in the ophthalmology service of the Corporation Parc Tauli
Key inclusion criteria (1 listed)
- People over 18 years of age who require intravitreal therapy in the ophthalmology service
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| It is a implementation a program incorporating nurses trained in administering intravitreal injections within the functional unit of Ophthalmology following the usual techniqueInternationally, 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. | Procedure or surgery | – |
Primary outcome
Complications presented during the IIV technique
Time frame: In each injection during and after the procedure until the end of treatment
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)
Late post-procedure complications
Time frame: In each injection during and after the procedure until the end of treatment
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.
13 secondary outcomes
Sociodemographic variables
Time frame: At the beginning of treatment
Date of treatment indication
Time frame: At the beginning of treatment
Ocular Diagnosis
Time frame: At the beginning of treatment
Ocular comorbidity
Time frame: At the beginning of treatment
Previous experience
Time frame: At the beginning of treatment
Companion
Time frame: In each injection until the end of the treatment
Visit to the ophthalmologist between therapies
Time frame: In each injection until the end of the treatment
Anxiety level
Time frame: In each injection until the end of the treatment
Treated eye
Time frame: In each injection until the end of the treatment
Ophthalmologist visit during the session
Time frame: In each injection until the end of the treatment
IVI Medication
Time frame: In each injection until the end of the treatment
Patient Pain
Time frame: In each injection until the end of the treatment
Patient Satisfaction
Time frame: In each injection until the end of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Edema and Macular Degeneration, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications presented during the IIV technique (time frame: In each injection during and after the procedure until the end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.