Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429819
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
2007-01-31
Brief Title:
Neurovascular Coupling in Eyes of Glaucoma Patients
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Neurovascular Coupling in Eyes of Glaucoma Patients
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 125 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
The response of a major temporal superior and inferior retinal artery and vein to a 60 seconds 125 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
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 125 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 andor 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
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 125 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Swiss National Foundation | OTHER_GRANT | 3200B0-113685 | None |