Primary Open Angle GlaucomaNCT01795014
Correlation of Orbital Cerebrospinal Fluid Pressure and Retinal Venous Outflow in Primary Open-angle Glaucoma
An observational study of Primary Open Angle Glaucoma and Normal Tension Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
A spontaneous venous pulsation over the optic disc is an ophthalmological sign that can potentially be found in up to 98% of healthy individuals. In fact, the lack of this spontaneous retinal venous pulse has been consistently implicated as an indicator of a more advanced form of certain ocular diseases, specifically… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma, Normal Tension Glaucoma
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Apr 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic
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
- having no other ocular diseases besides glaucoma
Who cannot join
- history of ocular trauma
- intraocular surgery (except for cataract surgery)
- eye disease (except glaucoma)
- systemic diseases with ocular involvement like diabetes or graves ophthalmopathy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven
Leuven, Flemish Brabant, 3000 Leuven
Evelien Vandewalle, Md, PhD, eve_vandewalle@hotmail.com
Ingeborg Stalmans, MD, PhD
About this study
Official title: Analysis of the Relationship Between Optic Nerve Sheath Diameter and the Spontaneous Venous Pulsation in Primary Open-angle Glaucoma
A spontaneous venous pulsation over the optic disc is an ophthalmological sign that can potentially be found in up to 98% of healthy individuals. In fact, the lack of this spontaneous retinal venous pulse has been consistently implicated as an indicator of a more advanced form of certain ocular diseases, specifically open-angle glaucoma. However, the mechanisms behind these change in the retinal venous system are not clear. Some evidence suggests that extraocular features such as intracranial pressure (ICP) may play a role in regulating the intraocular venous outflow. The reasons for this hypothetical downstream resistance to venous outflow are not fully understood, with advances in this field being limited by our technological-imposed difficulties in assessing the structures behind the globe.
However, it has been established that the volume of cerebrospinal fluid surrounding the optic nerve correlates with the ICP at the orbital level. Recent studies have suggested that non-invasive ultrasound-based recordings have correlated this surrogate for orbital ICP with the intraocular pressure (IOP) in glaucoma patients with an otherwise normal IOP range (normal tension glaucoma - NTG).
The investigators will therefore conduct a test to determine if this cerebrospinal volume surrounding the optic nerve correlates with the frequency of observation of an otherwise signal of venous dysfunction (i.e. the lack of a visible pulse in the retinal central vein) Additionally, the investigators will assess if this correlation is different between healthy individuals, hypertensive primary-open angle glaucoma or NTG patients.
Read the detailed description
- Spontaneous venous pulsation will be recorded after a one minute fundoscopy observation.
- B-mode ultrasound of the orbit will be performed and the optic nerve sheath diameter measured 3mm behind the globe
- Visual field examination will be performed.
- Structural examination of the optic disc (confocal microscopy) will be performed.
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma
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 | Healthy volunteers 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 IOP above 21 mmHg that could suggest possible glaucoma suspects. | |
| Primary open-angle Glaucoma | Patients 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 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.
Spontaneous venous pulsation
Assessing whether the frequency of the spontaneous venous pulsation phenomenon is associated with the optic nerve sheath diameter in glaucoma patients
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- 90 participants (estimated)
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
- NCT01795014
- Sponsor's protocol ID
- SVP0002
- Status last verified
- Jan 2013
- First submitted
- 12 Feb 2013
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Relationship Between Optic Nerve Sheath Diameter and the Spontaneous Venous Pulsation in Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT01795014
- Acronym / sponsor ID
- SVP0002
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 20 Feb 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.
A spontaneous venous pulsation over the optic disc is an ophthalmological sign that can potentially be found in up to 98% of healthy individuals. In fact, the lack of this spontaneous retinal venous pulse has been consistently implicated as an indicator of a more advanced form of certain ocular diseases, specifically open-angle glaucoma. However, the mechanisms behind these change in the retinal venous system are not clear. Some evidence suggests that extraocular features such as intracranial pressure (ICP) may play a role in regulating the intraocular venous outflow. The reasons for this hypothetical downstream resistance to venous outflow are not fully understood, with advances in this field being limited by our technological-imposed difficulties in assessing the structures behind the globe.
However, it has been established that the volume of cerebrospinal fluid surrounding the optic nerve correlates with the ICP at the orbital level. Recent studies have suggested that non-invasive ultrasound-based recordings have correlated this surrogate for orbital ICP with the intraocular pressure (IOP) in glaucoma patients with an otherwise normal IOP range (normal tension glaucoma - NTG).
The investigators will therefore conduct a test to determine if this cerebrospinal volume surrounding the optic nerve correlates with the frequency of observation of an otherwise signal of venous dysfunction (i.e. the lack of a visible pulse in the retinal central vein) Additionally, the investigators will assess if this correlation is different between healthy individuals, hypertensive primary-open angle glaucoma or NTG patients.
Detailed description
- Spontaneous venous pulsation will be recorded after a one minute fundoscopy observation.
- B-mode ultrasound of the orbit will be performed and the optic nerve sheath diameter measured 3mm behind the globe
- Visual field examination will be performed.
- Structural examination of the optic disc (confocal microscopy) will be performed.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Healthy volunteers 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 IOP above 21 mmHg that could suggest possible glaucoma suspects. |
| Primary open-angle Glaucoma | – | –Patients 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 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
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- individuals over 18 years old
- willing to sign an informed consent and able to comply with the requirements of the study
- having no other ocular diseases besides glaucoma
Key exclusion criteria (4 listed)
- history of ocular trauma
- intraocular surgery (except for cataract surgery)
- eye disease (except glaucoma)
- 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
Spontaneous venous pulsation
Time frame: Up to 3 months
Assessing whether the frequency of the spontaneous venous pulsation phenomenon is associated with the optic nerve sheath diameter in glaucoma patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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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 Primary Open Angle Glaucoma and Normal Tension 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 3 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: status not confirmed, as of the sponsor's last update on 20 Feb 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous venous pulsation (time frame: Up to 3 months). 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 20 Feb 2013.