Open Angle GlaucomaNCT01840215
Study on the Impact of Ocular Anesthetic Procedures in Ocular Blood Flow
An observational study of Open Angle Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Anaesthetic procedures in ophthalmology surgery have been a subject rapidly evolving in the past decades. When deciding for a retrobulbar block, the local injection of varying mixtures and volumes of fast-acting anesthetics (such as lidocaine) - with or without a vasoconstrictive agent (such as adrenaline) - coupled… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- How many people
- 240 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2013to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care setting
Who may be able to join
- individuals over 18 years old
- willing to sign an informed consent and able to comply with the requirements of the study
Who cannot join
- history of ocular trauma
- previous extraocular surgery
- ocular disease other than the one motivating surgery
- systemic diseases with ocular involvement like diabetes or Graves Ophthalmopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Topical, Retrobulbar and General Anesthesia in Ocular Blood Flow
Anaesthetic procedures in ophthalmology surgery have been a subject rapidly evolving in the past decades. When deciding for a retrobulbar block, the local injection of varying mixtures and volumes of fast-acting anesthetics (such as lidocaine) - with or without a vasoconstrictive agent (such as adrenaline) - coupled with Hyaluronidase have been the standard care to provide painless surgery while minimizing the possible risks such as increased intraocular pressure (IOP), brainstem anesthesia, toxic reaction and ocular blood flow changes. These iatrogenic-induced vascular dysfunctions have been also suggested to play a role in intra-operatory vision loss (a "wipe-out" phenomenon) in patients with advanced glaucoma.
The rationale for the use of epinephrine in retrobulbar anesthesia is to slow absorption of the anesthetic in general circulation and thus to achieve a longer effect in the orbit. However, studies on ocular blood flow after adrenaline-containing compounds have consistently showed a decrease in ocular blood flow, thus raising the issue of whether it should be used in patients with known vascular dysfunction, namely glaucoma patients. Nevertheless, there has been no study to verify this claim concerning the safety of non-adrenaline containing anesthetics.
Read more
Injecting a pre-determined volume of anesthetic compound behind the globe, regardless of its formulation has also been debated. The orbital pressure increase can lead to a number of adverse reactions, not only increasing IOP but also potentially decreasing vascular input by local compression. In glaucoma for instance, there has been suggested optic nerve sheaths to be less elastic than in healthy individuals, potentially making this structure less compliant to outside compression. These more rigid orbital tissues could also impair the orbit's ability to deal with the iatrogenic increased volume.
As seen, the current concepts on the impact of ocular anesthesiology in the orbit and the vascular supply to the eye are limited to a small number of non-homogeneous studies. We aim to study this impact through a non-invasive, widely established ultrasound based method of ocular blood flow research (color Doppler Imaging). Potentially, our study could help determine a taylor-made choice of the anesthesiology procedure to apply to a specific patient, thereby advancing the current standard of care in ophthalmology.
Read the detailed description
- Ultrasound B-mode scans will be performed before and after the anesthetic procedure
- Doppler scan will be added to the B-mode ultrasound to register the blood flow pattern of the ophthalmic and central retinal arteries
- Blood pressure and heart rate will be monitored
- Conditions
- Open Angle Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Patients scheduled for elective ophthalmic surgery with no family history of glaucoma, an increased or asymmetrical cup/disc ratio or any other optic disc structural change (notching, disc hemorrhage) or an intraocular pressure (IOP) above 21 mmHg that could suggest possible glaucoma suspects. | |
| Primary open-angle Glaucoma | Patients scheduled for an elective glaucoma surgery that present with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at least one measurement of IOP of >21 mmHg required | |
| Normal Tension Glaucoma | Patients scheduled for an elective glaucoma surgery that present with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at maximum recorded IOP of < 21 mmHg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular blood flow change
The investigators will test whether anesthetic procedures in ophthalmic surgery (topical, retrobulbar and general anesthesia) induce a change in retrobulbar blood flow. The difference in ocular blood flow velocities between pre and post anesthetic induction will be performed.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionDec 2014
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 Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingeborg Stalmans, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840215
- Sponsor's protocol ID
- S16022013
- Status last verified
- Feb 2013
- First submitted
- 17 Apr 2013
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pargana J, Willekens K, Van Keer K, Van Calster J, Deckers K, Vertommen J, Vandewalle E, Stalmans P, Stalmans I, Abegao Pinto L. General anesthesia significantly decreases arterial retrobulbar blood flow velocity in glaucoma patients. Eur J Ophthalmol. 2026 Jul 30:11206721261470968. doi: 10.1177/11206721261470968. Online ahead of print.
PubMed 42530516
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Topical, Retrobulbar and General Anesthesia in Ocular Blood Flow
- ClinicalTrials.gov ID
- NCT01840215
- Acronym / sponsor ID
- S16022013
- Conditions
- Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Apr 2013 (estimated)
- 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.
Anaesthetic procedures in ophthalmology surgery have been a subject rapidly evolving in the past decades. When deciding for a retrobulbar block, the local injection of varying mixtures and volumes of fast-acting anesthetics (such as lidocaine) - with or without a vasoconstrictive agent (such as adrenaline) - coupled with Hyaluronidase have been the standard care to provide painless surgery while minimizing the possible risks such as increased intraocular pressure (IOP), brainstem anesthesia, toxic reaction and ocular blood flow changes. These iatrogenic-induced vascular dysfunctions have been also suggested to play a role in intra-operatory vision loss (a "wipe-out" phenomenon) in patients with advanced glaucoma.
The rationale for the use of epinephrine in retrobulbar anesthesia is to slow absorption of the anesthetic in general circulation and thus to achieve a longer effect in the orbit. However, studies on ocular blood flow after adrenaline-containing compounds have consistently showed a decrease in ocular blood flow, thus raising the issue of whether it should be used in patients with known vascular dysfunction, namely glaucoma patients. Nevertheless, there has been no study to verify this claim concerning the safety of non-adrenaline containing anesthetics.
Injecting a pre-determined volume of anesthetic compound behind the globe, regardless of its formulation has also been debated. The orbital pressure increase can lead to a number of adverse reactions, not only increasing IOP but also potentially decreasing vascular input by local compression. In glaucoma for instance, there has been suggested optic nerve sheaths to be less elastic than in healthy individuals, potentially making this structure less compliant to outside compression. These more rigid orbital tissues could also impair the orbit's ability to deal with the iatrogenic increased volume.
As seen, the current concepts on the impact of ocular anesthesiology in the orbit and the vascular supply to the eye are limited to a small number of non-homogeneous studies. We aim to study this impact through a non-invasive, widely established ultrasound based method of ocular blood flow research (color Doppler Imaging). Potentially, our study could help determine a taylor-made choice of the anesthesiology procedure to apply to a specific patient, thereby advancing the current standard of care in ophthalmology.
Detailed description
- Ultrasound B-mode scans will be performed before and after the anesthetic procedure
- Doppler scan will be added to the B-mode ultrasound to register the blood flow pattern of the ophthalmic and central retinal arteries
- Blood pressure and heart rate will be monitored
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Patients scheduled for elective ophthalmic surgery with no family history of glaucoma, an increased or asymmetrical cup/disc ratio or any other optic disc structural change (notching, disc hemorrhage) or an intraocular pressure (IOP) above 21 mmHg that could suggest possible glaucoma suspects. |
| Primary open-angle Glaucoma | – | –Patients scheduled for an elective glaucoma surgery that present with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at least one measurement of IOP of >21 mmHg required |
| Normal Tension Glaucoma | – | –Patients scheduled for an elective glaucoma surgery that present with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at maximum recorded IOP of < 21 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care setting
Key inclusion criteria (2 listed)
- individuals over 18 years old
- willing to sign an informed consent and able to comply with the requirements of the study
Key exclusion criteria (4 listed)
- history of ocular trauma
- previous extraocular surgery
- ocular disease other than the one motivating surgery
- systemic diseases with ocular involvement like diabetes or Graves Ophthalmopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ocular blood flow change
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours
The investigators will test whether anesthetic procedures in ophthalmic surgery (topical, retrobulbar and general anesthesia) induce a change in retrobulbar blood flow. The difference in ocular blood flow velocities between pre and post anesthetic induction will be performed.
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 29 May 2015.
- Derived from this study: PubMed 42530516Pargana J, Willekens K, Van Keer K, Van Calster J, Deckers K, Vertommen J, Vandewalle E, Stalmans P, Stalmans I, Abegao Pinto L. General anesthesia significantly decreases arterial retrobulbar blood flow velocity in glaucoma patients. Eur J Ophthalmol. 2026 Jul 30:11206721261470968. doi: 10.1177/11206721261470968. Online ahead of print.
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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.
Ingeborg Stalmans, MD, PhD principal investigator
UZ Leuven
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 Open Angle Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 inclusion and 4 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 29 May 2015. 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 Belgium. 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?
Ocular blood flow change (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours). 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 NCT01840215, 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 29 May 2015.