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CompletedNCT00429819Updated Dec 16, 2014

Neurovascular Coupling in Eyes of Glaucoma Patients

An observational study in Glaucoma and Ocular Hypertension, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2014-12-16.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
40 Years to 79 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • Glaucoma
  • Ocular Hypertension
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 100 is close to the median of 103 across 454 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

glaucoma patients ocular hypertension

Inclusion criteria

  • Glaucoma
  • Ocular hypertension

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)
06

What researchers measure

Primary outcomes

  1. Prognostic value of Flicker Response in glaucoma patients and ocular hypertension (OHT)

    Time frame: up to 3 years

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Study locations

1 site
  • University Eye Clinic
    Basel, Basel-Stadt 4031, Switzerland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00429819
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Feb 1, 2007
Start date
Dec 2006
Primary completion
Jun 2014
Completion
Dec 2014
Last update
Dec 16, 2014

Study contacts

Selim Orgül, MD
study director · University Eye Clinic Basel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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