Study on the Oxygen Saturation in Pulsating and Non-pulsating Central Retinal Veins

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT01794442
Collaborator
(none)
120
1
35
3.4

Study Details

Study Description

Brief Summary

Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Recent findings have confirmed that there is a direct correlation between the levels of venous oxygen saturation and the degree of the glaucomatous disease, presumably due to a decrease in retinal cell metabolism.

However, glaucoma patients have been suggested to have a different pattern in retinal venous circulation. For instance, the observation of a visible pulsating central retinal vein is a phenomenon that can be seen in up to 98% of the healthy individuals but is identifiable in less than 50% of glaucoma patients. While the nature of these venous changes are not year clear, the lack of a visible pulsating flow could suggest an increased intraluminal venous pressure due to some obstruction from both ocular or extraocular structures. This undetermined increase in venous pulse pressure could then significantly decrease perfusion pressures and therefore further decrease oxygen supply to the retinal tissues.

The investigators will therefore try to determine if there is a significant difference between the oxygen saturation of the retinal vessels in both glaucoma patients with and without a visible pulsating central vein

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. Visual field examen will be performed.

    2. Structural examination of the optic disc (confocal microscopy) will be performed.

    3. Spontaneous venous pulsation will be recorded after a one minute fundoscopy observation.

    4. Oximetry reading in the non-contact retinal oximetry of the first 3 order retinal vessels

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between Retinal Metabolism and the Observation of a Visible Retinal Spontaneous Venous Pulse
    Study Start Date :
    Jan 1, 2013
    Anticipated Primary Completion Date :
    Dec 1, 2015
    Anticipated Study Completion Date :
    Dec 1, 2015

    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. Retinal Oxygen saturation in retinal veins with absent pulsation [Up to 3 months]

      We will assess, through analysing the oximetry recordings from both pulsating and non-pulsating retinal veins, whether there are any differences in venous or arterial-venous oxygen saturation in primary open-angle 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Vlaams-Brabant Belgium 3000 Leuven

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01794442
    Other Study ID Numbers:
    • S120213
    First Posted:
    Feb 18, 2013
    Last Update Posted:
    May 29, 2015
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 29, 2015