Study on Ocular Blood Flow and the Orbital Cerebrospinal Fluid Pressure in Glaucoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01802463|
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : February 3, 2014
Ocular blood flow has been consistently demonstrated to be altered in glaucoma patients when compared to otherwise healthy individuals. Numerous Doppler studies have shown a decrease in flow velocities in the retrobulbar arteries in what appears to be related to the degree of the glaucomatous disease.
The anatomic pathway of the several arteries into the eye is intricately complicate, with at least one of them (the central retina artery) penetrating the optic nerve before entering the eye and supplying the innermost structures of the globe. As the optic nerve is surrounded by a layer of cerebrospinal fluid (CSF) which is in continuity with the rest of the central nervous system, this central retinal artery has also to cross this CSF containing compartment. Because of the intrinsic pressure this CSF - corresponding to the intracranial pressure at the orbital level - the possibility exists that this pressure around the optic disc could affect the blood flow of the arteries that go through it.
The investigators will try to detect if a correlation exists between the optic nerve sheath diameter and the blood flow in the retrobulbar vessels of glaucoma patients.
|Condition or disease|
|Open Angle Glaucoma Normal Tension Glaucoma|
- Visual field testing will be performed.
- Structural analysis of the retinal nerve fiber layer (through confocal microscopy)will be performed.
- Color Doppler Imaging of the retrobulbar vessels will be performed. Peak and end diastolic velocities, resistivity index will be calculated from the Doppler waveform.
- B-scan ultrasound of the optic nerve sheath diameter will be performed. the measure will take place at 3mm behind the globe.
|Study Type :||Observational|
|Actual Enrollment :||197 participants|
|Official Title:||Correlation Between Ocular Blood Flow and the Optic Nerve Sheath Diameter in Patients With Primary Open-angle Glaucoma|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
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
- Flow velocity of retrobulbar vessels [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802463
|Leuven, Flemish Brabant, Belgium, 3000 Leuven|