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GlaucomaNCT00430209

Neurovascular Coupling in Eyes of Glaucoma Patients

An observational study of Glaucoma and Ocular Hypertension, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Glaucoma, Ocular Hypertension
How many people
150 participants
Where
1 siteSwitzerland
Study dates
Dec 2006to Dec 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: glaucoma patients ocular hypertensives normal controls

Who may be able to join

  • glaucoma
  • ocular hypertension

Who cannot join

  • highest ever measured intraocular pressure (IOP) equal or higher than 30 mmHg
  • peripapillary hemorrhage
  • any suspicion of progression
  • PEX (pseudo exfoliations syndrome) or pigment dispersion syndrome
  • a history of an acute glaucoma attack
  • chamber angle dysgenesia
Show all 17Show fewer
  • any form of secondary glaucoma
  • diabetes
  • high levels of blood lipids
  • systemic or ocular circulatory diseases
  • medication, drugs, alcohol, smoking
  • systolic blood pressure above 145mmHg or a diastolic above 95mmHg
  • visual acuity worse than 20/25
  • high ametropia (spherical equivalent < -5 diopters or > +3 diopters)
  • astigmatism above 2 diopters
  • significant cataract
  • filtering procedures

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Eye Clinic

    Basel, Canton of Basel-City, 4031

Other trials in Switzerland

About this study

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 ocular coherence tomography (OCT) device) glaucomatous damage progression, in order to test the predictive power of the retinal vascular flicker response for glaucoma progression.

Read the 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.

Medical subject headings
Glaucoma, Ocular Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response to flicker light in glaucoma

    Response to flicker light in glaucoma, ocular hypertension (OHT) and normal subjects

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00430209
Sponsor's protocol ID
083-GUK-2006-001
Other IDs
Swiss National Foundation
Status last verified
Dec 2013
First submitted
31 Jan 2007
Last updated
11 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • Gugleta K, Waldmann N, Polunina A, Kochkorov A, Katamay R, Flammer J, Orgul S. Retinal neurovascular coupling in patients with glaucoma and ocular hypertension and its association with the level of glaucomatous damage. Graefes Arch Clin Exp Ophthalmol. 2013 Jun;251(6):1577-85. doi: 10.1007/s00417-013-2276-9. Epub 2013 Feb 19.

    PubMed 23417339
  • Gugleta K, Kochkorov A, Waldmann N, Polunina A, Katamay R, Flammer J, Orgul S. Dynamics of retinal vessel response to flicker light in glaucoma patients and ocular hypertensives. Graefes Arch Clin Exp Ophthalmol. 2012 Apr;250(4):589-94. doi: 10.1007/s00417-011-1842-2. Epub 2011 Oct 19.

    PubMed 22008947
  • Portmann N, Gugleta K, Kochkorov A, Polunina A, Flammer J, Orgul S. Choroidal blood flow response to isometric exercise in glaucoma patients and patients with ocular hypertension. Invest Ophthalmol Vis Sci. 2011 Sep 9;52(10):7068-73. doi: 10.1167/iovs.11-7758.

    PubMed 21828157

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma and Ocular Hypertension, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to flicker light in glaucoma (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00430209, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.

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