Clincosm LogoSign in Get a demo

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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT01795014
Collaborator
(none)
90
Enrollment
1
Location
3
Duration (Months)
30.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Apr 1, 2013
    Anticipated Study Completion Date :
    Apr 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Spontaneous venous pulsation [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KU Leuven Leuven Flemish Brabant Belgium 3000 Leuven

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    • Principal Investigator: Ingeborg Stalmans, MD, PhD, UZ Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01795014
    Other Study ID Numbers:
    • SVP0002
    First Posted:
    Feb 20, 2013
    Last Update Posted:
    Feb 20, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle
    Low Tension Glaucoma

    Study Results

    No Results Posted as of Feb 20, 2013