Study on Ocular Blood Flow and the Orbital Cerebrospinal Fluid Pressure in Glaucoma

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT01802463
Collaborator
(none)
197
1
12
16.4

Study Details

Study Description

Brief Summary

Ocular blood flow has been consistently demonstrated to be altered in glaucoma patients when compared to otherwise healthy individuals. Numerous Doppler studies have shown a decrease in flow velocities in the retrobulbar arteries in what appears to be related to the degree of the glaucomatous disease.

The anatomic pathway of the several arteries into the eye is intricately complicate, with at least one of them (the central retina artery) penetrating the optic nerve before entering the eye and supplying the innermost structures of the globe. As the optic nerve is surrounded by a layer of cerebrospinal fluid (CSF) which is in continuity with the rest of the central nervous system, this central retinal artery has also to cross this CSF containing compartment. Because of the intrinsic pressure this CSF - corresponding to the intracranial pressure at the orbital level - the possibility exists that this pressure around the optic disc could affect the blood flow of the arteries that go through it.

The investigators will try to detect if a correlation exists between the optic nerve sheath diameter and the blood flow in the retrobulbar vessels of glaucoma patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. Visual field testing will be performed.

    2. Structural analysis of the retinal nerve fiber layer (through confocal microscopy)will be performed.

    3. Color Doppler Imaging of the retrobulbar vessels will be performed. Peak and end diastolic velocities, resistivity index will be calculated from the Doppler waveform.

    4. B-scan ultrasound of the optic nerve sheath diameter will be performed. the measure will take place at 3mm behind the globe.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    197 participants
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between Ocular Blood Flow and the Optic Nerve Sheath Diameter in Patients With Primary Open-angle Glaucoma
    Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Jan 1, 2014
    Actual Study Completion Date :
    Jan 1, 2014

    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 intraocular pressure (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. Flow velocity of retrobulbar vessels [Participants will be followed for the duration of hospital stay, an expected average of 2 hours]

    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

    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

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01802463
    Other Study ID Numbers:
    • S130213
    First Posted:
    Mar 1, 2013
    Last Update Posted:
    Feb 3, 2014
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 3, 2014