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Correlation of Orbital Cerebrospinal Fluid Pressure and Retinal Venous Outflow in Primary Open-angle Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01795014
Recruitment Status : Unknown
Verified January 2013 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : February 20, 2013
Last Update Posted : February 20, 2013
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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 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.

Condition or disease
Primary Open Angle Glaucoma Normal Tension Glaucoma

Detailed Description:
  1. Spontaneous venous pulsation will be recorded after a one minute fundoscopy observation.
  2. B-mode ultrasound of the orbit will be performed and the optic nerve sheath diameter measured 3mm behind the globe
  3. Visual field examination will be performed.
  4. Structural examination of the optic disc (confocal microscopy) will be performed.

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Study Type : Observational
Estimated Enrollment : 90 participants
Time Perspective: Prospective
Official Title: Analysis of the Relationship Between Optic Nerve Sheath Diameter and the Spontaneous Venous Pulsation in Primary Open-angle Glaucoma
Study Start Date : January 2013
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
primary care clinic

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • history of ocular trauma
  • intraocular surgery (except for cataract surgery)
  • eye disease (except glaucoma)
  • systemic diseases with ocular involvement like diabetes or graves ophthalmopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01795014

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KU Leuven Recruiting
Leuven, Flemish Brabant, Belgium, 3000 Leuven
Contact: Evelien Vandewalle, Md, PhD   
Principal Investigator: Ingeborg Stalmans, MD, PhD         
Sub-Investigator: Evelien Vandewalle, MD, PhD         
Sub-Investigator: Luís Pinto, MD, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Ingeborg Stalmans, MD, PhD UZ Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01795014     History of Changes
Other Study ID Numbers: SVP0002
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases