Neurovascular Coupling in Eyes of Glaucoma Patients

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT00429819
Collaborator
(none)
100
1
96
1

Study Details

Study Description

Brief Summary

We hypothesize that glaucoma patients demonstrate an impaired retinal vascular response to the flicker stimulus, and that this disturbance is predictive of the progression of glaucomatous damage.

The response of a major temporal superior and inferior retinal artery and vein to a 60 seconds 12.5 Hz flicker light stimulation in 50 glaucoma patients, 50 ocular hypertensives and 50 controls (using the Retinal Vessel Analyzer) and to investigate how intraocular pressure relates to neurovascular coupling. In addition, 50 glaucoma patients and 50 ocular hypertension patients will be followed for 3 years for functional (visual field, automated perimetry with Octopus device) and morphological (retinal nerve fiber layer thickness, Optical Coherence Tomography Stratus (OCT) device) glaucomatous damage progression, in order to test the predictive power of the retinal vascular flicker response for glaucoma progression.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Rationale: The term neurovascular coupling refers to the vascular response to an increased neuronal activity. The contact of the nerve terminals to the cortical blood vessels is mostly realized through astrocytes. A major defining property of glaucoma, cupping of the optic disc, implies tissue remodeling of the optic nerve head and involves an astrocytic responses. A malfunction of the astrocytes in glaucoma may lead not only to the hallmark of glaucoma, cupping and death of retinal ganglion cells, but also to an accompanying or even preceding disturbance in ocular neurovascular coupling. The retinal vascular bed was chosen because of the high reproducibility of the dynamic retinal vessel diameter analysis and because recently the hypoxia-inducible factor 1α was found not only in the glia of the optic nerve head but also in the retina of glaucomatous donor eyes and predominantly in retinal locations closely concordant with the locations of visual field defects recorded in these eyes, raising questions about the site of primary damage in glaucoma. It is hoped that this research project will help provide a workable tool and a model able not only to identify a risk factor for glaucoma, but in the future to explore possible therapeutic avenues to modify the course of the disease.

    Working hypothesis: We hypothesize that glaucoma patients demonstrate an impaired retinal vascular response to the flicker stimulus, and that this disturbance is predictive of the progression of glaucomatous damage Subjects and Methods The present protocol intends to explore the response of a major temporal superior and inferior retinal artery and vein to a 60 seconds 12.5 Hz flicker light stimulation in 50 glaucoma patients, 50 ocular hypertensives and 50 controls (using the Retinal Vessel Analyzer) and to investigate how intraocular pressure relates to neurovascular coupling. In addition, 50 glaucoma patients and 50 ocular hypertension patients will be followed for 3 years for functional (visual field, automated perimetry with Octopus device) and morphological (retinal nerve fiber layer thickness, Optical Coherence Tomography Stratus OCT device) glaucomatous damage progression, in order to test the predictive power of the retinal vascular flicker response for glaucoma progression. Patients will be recruited in the University Eye Clinic Basel, a notification in the University Hospital of Basel and/or advertisement in a newspaper will inform potential healthy volunteers of the opportunity to participate in a scientific research project.

    Study Course: Study is divided in the cross-sectional and in the cohort part. In the former, first the screening examination will be performed, to establish an eligibility of a patient / control subject for the study. Thereafter, the measurements described above will follow, which will conclude the cross-sectional part of the study. Glaucoma patients and patients with ocular hypertension will be offered a possibility to enter the cohort-study, with a 3-year follow-up embedded in the clinical routine and consisting of biannual repeated measurements outlined above.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Neurovascular Coupling in Eyes of Glaucoma Patients
    Study Start Date :
    Dec 1, 2006
    Actual Primary Completion Date :
    Jun 1, 2014
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Prognostic value of Flicker Response in glaucoma patients and ocular hypertension (OHT) [up to 3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Glaucoma

    • Ocular hypertension

    Exclusion Criteria:
    • PEX or pigment dispersion syndrome

    • A history of an acute glaucoma attack

    • Chamber angle dysgenesia

    • Any form of secondary glaucoma

    • Diabetes

    • High levels of blood lipids

    • Systemic or ocular circulatory diseases

    • Medication, drugs, alcohol, smoking

    • Systolic blood pressure above 145 mmHg or a diastolic above 95 mmHg

    • Visual acuity worse than 20/25

    • High ametropia (spherical equivalent < -5 diopters or > +3 diopters)

    • Astigmatism above 2 diopters

    • Significant cataract filtering procedures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Eye Clinic Basel Basel-Stadt Switzerland 4031

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland

    Investigators

    • Study Director: Selim Orgül, MD, University Eye Clinic Basel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT00429819
    Other Study ID Numbers:
    • 084-GUK-2006-002
    • Swiss National Foundation
    First Posted:
    Feb 1, 2007
    Last Update Posted:
    Dec 16, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 16, 2014