Vitreoretinal DiseasesSAFE-VISANCT04257188
Safety and Feasibility of Sutureless Pars-plana Vitrectomy in Sub-Tenon Anesthesia
An observational study of Vitreoretinal Diseases, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of this prospective study is to investigate the feasibility of performing minimally invasive vitrectomy under sub-tenon anesthesia in terms of intraoperative patients' tolerance and the surgeon's confidence. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Vitreoretinal Diseases
- What is being tested?
- minimally invasive vitrectomy under subtenon anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteGermany
- Study dates
- 7 Nov 2019to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population is acquired from the patient collective of the eye clinic of the University Hospital Aachen and have a medical indication for vitrectomy, which is independent of study participation.
Who may be able to join
- Age over 40 years
- Presence of a clinical condition that requires surgical treatment with vitrectomy and does not necessarily require general anesthesia (retinal detachment, endophthalmitis, vitreous hemorrhage, after silicone oil surgery, vitreomacular traction, epiretinal gliosis, macular holes, subretinal bleeding, lens luxation).
- The medical indication for vitrectomy is not linked to study participation. Not until the patient has consented to the vitrectomy (standardized information forms) potential study subjects will be approached to participate in the clinical trial.
- Willingness to participate in the clinical trial
- Understanding the objectives of the clinical trial and the study process
- Signed informed consent form
Who cannot join
- Concomitant diseases of the eye
- State after filtering glaucoma operations
- Distinct corneal opacities, which make the examination considerably more difficult
- Complicated proliferative vitreoretinopathy
- Lack of understanding of the study, its objectives and study conduct
- Psychiatric diseases
- Pregnancy
- Simultaneous participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Ophthalmology, University Hospital RWTH Aachen
Aachen, 52066
About this study
Official title: A Prospective, One-center Clinical Trial to Identify the Safety and Feasibility of Sutureless Pars-plana Vitrectomy Performed in Sub-tenon Anesthesia.
The aim of this prospective study is to investigate the feasibility of performing minimally invasive vitrectomy under sub-tenon anesthesia in terms of intraoperative patients' tolerance and the surgeon's confidence. In particular, the tolerance and pain sensation during the operation as well as the possible perception of light and colour sensations are to be recorded with the help of questionnaires. In addition, the surgeon's impressions regarding eye motility, chemosis and general feasibility will be evaluated.
Read the detailed description
A prospective, one-center clinical trial to identify the safety and feasibility of sutureless pars-plana vitrectomy performed in sub-tenon anesthesia.
Background:
In Germany pars-plana vitrectomies are mostly performed in general anesthesia. This requires the immediate availability of a trained anesthesiology team, which is not always granted, especially in urgent eye disease (i.e. endophthalmitis, high risk retinal detachment). Furthermore, some patients are not suitable for general anesthesia due to systemic diseases (i.e. cardio-vascular diseases). There are several procedures of local ocular anesthesia (i.e. peribulbar, retrobulbar, sub-tenon anesthesia). The main advantage of sub-tenon anesthesia is the use of a blunt cannula limiting the risk of potential complications.
Purpose:
The purpose of this study is to investigate the safety of local sub-tenon anesthesia procedure for sutureless vitrectomy (anesthetic mixture: 2ml xylocaine and 2ml bupivacaine) in a prospective clinical study design.
Objectives:
Primary outcome: The evaluation of 1. sensation of pain, 2. patients' intraoperative discomfort and 3. visual sensations using the standardized questionnaires (WONG-BAKER Faces Scale, Visual Analog Scale and individual questions).
Secondary Outcome: The evaluation of 1. chemosis, 2. eye movement, 3. surgeon's general feeling of comfort during surgery (rating scale).
- Conditions
- Vitreoretinal Diseases
- Being tested
- minimally invasive vitrectomy under subtenon anaesthesia
- Keywords
- Sub-tenon Anesthesia, Vitrectomy, Sutureless vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive vitrectomy under subtenon anaesthesiaProcedure or surgery
The safety and feasibility in terms of tolerance and pain sensation during the surgery as well as the possible perception of light and colour sensations in minimally invasive vitrectomy under sub-tenon anesthesia shall be investigated.
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive vitrectomy under subtenon anaesthesia | Not described Receives: Procedure: minimally invasive vitrectomy under subtenon anaesthesia | |
| minimally invasive vitrectomy under general anaesthesia | Not described Receives: Procedure: minimally invasive vitrectomy under subtenon anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensation of pain
- 11-point numeric scale ranges from '0' (means "no pain") to '10' (means "worst pain imaginable"), Questionnaire
- Wong-Baker FACES® Scale (6 Faces, range no hurt - hurts worst), Questionnaire
Measured: 1 Day
Discomfort
11-point numeric scale ranges from '0' (means "no discomfort") to '10' (means "worst discomfort imaginable"), Questionnaire
Measured: 1 Day
Visual Sensations
4 questions, Likert scale ("yes", "no", "don't know/not sure"), Questionnaire
- perception of details during surgery (instruments, surgeon's face)
- perception of colors during surgery
- perception of lights or shadows
- no light perception at all during surgery
Measured: 1 Day
Secondary outcomes (3)
Chemosis
5-point numeric scale from '0' (means no chemosis) to 4 (means chemosis of all 4 eye quadrants), Questionnaire (surgeon)
Measured: 1 Day
Eye movement
4-point numeric scale: '0' (means ptosis and no motility), '1' (mild motility), '2' (moderate motility), '3' (full motility), Questionnaire (surgeon)
Measured: 1 Day
Surgeon's general feeling of comfort during the surgery
6-point numeric scale ranges from '1' (means best comfort conditions) to '6' (means worst comfort conditions) Questionnaire (surgeon)
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start7 Nov 2019
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitreoretinal DiseasesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonis Koutsonas, RWTH Aachen University
- Investigators
- Antonis Koutsonas, Dr. med., Principal investigator, Clinic for Ophthalmology, University Hospital RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257188
- Sponsor's protocol ID
- 19-169
- Acronym
- SAFE-VISA
- Status last verified
- Apr 2022
- First submitted
- 19 Nov 2019
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lohmann T, Baumgarten S, Prinz J, Walter P, Koutsonas A. Safety and feasibility of sutureless pars-plana vitrectomy in sub-Tenon anesthesia (SAFE-VISA): a prospective study. Eur J Med Res. 2023 Oct 30;28(1):472. doi: 10.1186/s40001-023-01447-2.
PubMed 37899488
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, One-center Clinical Trial to Identify the Safety and Feasibility of Sutureless Pars-plana Vitrectomy Performed in Sub-tenon Anesthesia.
- ClinicalTrials.gov ID
- NCT04257188
- Acronym / sponsor ID
- SAFE-VISA / 19-169
- Conditions
- Vitreoretinal Diseases
- Keywords
- Sub-tenon Anesthesia, Vitrectomy, Sutureless vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 5 Feb 2020 (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.
The aim of this prospective study is to investigate the feasibility of performing minimally invasive vitrectomy under sub-tenon anesthesia in terms of intraoperative patients' tolerance and the surgeon's confidence. In particular, the tolerance and pain sensation during the operation as well as the possible perception of light and colour sensations are to be recorded with the help of questionnaires. In addition, the surgeon's impressions regarding eye motility, chemosis and general feasibility will be evaluated.
Detailed description
A prospective, one-center clinical trial to identify the safety and feasibility of sutureless pars-plana vitrectomy performed in sub-tenon anesthesia.
Background:
In Germany pars-plana vitrectomies are mostly performed in general anesthesia. This requires the immediate availability of a trained anesthesiology team, which is not always granted, especially in urgent eye disease (i.e. endophthalmitis, high risk retinal detachment). Furthermore, some patients are not suitable for general anesthesia due to systemic diseases (i.e. cardio-vascular diseases). There are several procedures of local ocular anesthesia (i.e. peribulbar, retrobulbar, sub-tenon anesthesia). The main advantage of sub-tenon anesthesia is the use of a blunt cannula limiting the risk of potential complications.
Purpose:
The purpose of this study is to investigate the safety of local sub-tenon anesthesia procedure for sutureless vitrectomy (anesthetic mixture: 2ml xylocaine and 2ml bupivacaine) in a prospective clinical study design.
Objectives:
Primary outcome: The evaluation of 1. sensation of pain, 2. patients' intraoperative discomfort and 3. visual sensations using the standardized questionnaires (WONG-BAKER Faces Scale, Visual Analog Scale and individual questions).
Secondary Outcome: The evaluation of 1. chemosis, 2. eye movement, 3. surgeon's general feeling of comfort during surgery (rating scale).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive vitrectomy under subtenon anaesthesia | – | Procedure: minimally invasive vitrectomy under subtenon anaesthesia |
| minimally invasive vitrectomy under general anaesthesia | – | Procedure: minimally invasive vitrectomy under subtenon anaesthesia |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is acquired from the patient collective of the eye clinic of the University Hospital Aachen and have a medical indication for vitrectomy, which is independent of study participation.
Key inclusion criteria (6 listed)
- Age over 40 years
- Presence of a clinical condition that requires surgical treatment with vitrectomy and does not necessarily require general anesthesia (retinal detachment, endophthalmitis, vitreous hemorrhage, after silicone oil surgery, vitreomacular traction, epiretinal gliosis, macular holes, subretinal bleeding, lens luxation).
- Willingness to participate in the clinical trial
- Understanding the objectives of the clinical trial and the study process
- Signed informed consent form
Key exclusion criteria (8 listed)
- Concomitant diseases of the eye
- Lack of understanding of the study, its objectives and study conduct
- Psychiatric diseases
- Pregnancy
- Simultaneous participation in another clinical trial
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 |
|---|---|---|
| minimally invasive vitrectomy under subtenon anaesthesiaThe safety and feasibility in terms of tolerance and pain sensation during the surgery as well as the possible perception of light and colour sensations in minimally invasive vitrectomy under sub-tenon anesthesia shall be investigated. | Procedure or surgery | minimally invasive vitrectomy under general anaesthesia, minimally invasive vitrectomy under subtenon anaesthesia |
Primary outcome
Sensation of pain
Time frame: 1 Day
1. 11-point numeric scale ranges from '0' (means "no pain") to '10' (means "worst pain imaginable"), Questionnaire 2. Wong-Baker FACES® Scale (6 Faces, range no hurt - hurts worst), Questionnaire
Discomfort
Time frame: 1 Day
11-point numeric scale ranges from '0' (means "no discomfort") to '10' (means "worst discomfort imaginable"), Questionnaire
Visual Sensations
Time frame: 1 Day
4 questions, Likert scale ("yes", "no", "don't know/not sure"), Questionnaire 1. perception of details during surgery (instruments, surgeon's face) 2. perception of colors during surgery 3. perception of lights or shadows 4. no light perception at all during surgery
3 secondary outcomes
Chemosis
Time frame: 1 Day
Eye movement
Time frame: 1 Day
Surgeon's general feeling of comfort during the surgery
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 37899488Lohmann T, Baumgarten S, Prinz J, Walter P, Koutsonas A. Safety and feasibility of sutureless pars-plana vitrectomy in sub-Tenon anesthesia (SAFE-VISA): a prospective study. Eur J Med Res. 2023 Oct 30;28(1):472. doi: 10.1186/s40001-023-01447-2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Antonis Koutsonas, Dr. med. principal investigator
Clinic for Ophthalmology, University Hospital RWTH Aachen
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 Vitreoretinal Diseases, run by RWTH Aachen University at 1 site in Germany.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 5 May 2022. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensation of pain (time frame: 1 Day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04257188, which also lists 1 linked publication.
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 5 May 2022.