Study on the Oxygen Saturation in Pulsating and Non-pulsating Central Retinal Veins
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|ClinicalTrials.gov Identifier: NCT01794442|
Recruitment Status : Unknown
Verified January 2013 by Universitaire Ziekenhuizen Leuven.
Recruitment status was: Recruiting
First Posted : February 18, 2013
Last Update Posted : May 29, 2015
Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Recent findings have confirmed that there is a direct correlation between the levels of venous oxygen saturation and the degree of the glaucomatous disease, presumably due to a decrease in retinal cell metabolism.
However, glaucoma patients have been suggested to have a different pattern in retinal venous circulation. For instance, the observation of a visible pulsating central retinal vein is a phenomenon that can be seen in up to 98% of the healthy individuals but is identifiable in less than 50% of glaucoma patients. While the nature of these venous changes are not year clear, the lack of a visible pulsating flow could suggest an increased intraluminal venous pressure due to some obstruction from both ocular or extraocular structures. This undetermined increase in venous pulse pressure could then significantly decrease perfusion pressures and therefore further decrease oxygen supply to the retinal tissues.
The investigators will therefore try to determine if there is a significant difference between the oxygen saturation of the retinal vessels in both glaucoma patients with and without a visible pulsating central vein
|Condition or disease|
|Open Angle Glaucoma Normal Tension Glaucoma|
- Visual field examen will be performed.
- Structural examination of the optic disc (confocal microscopy) will be performed.
- Spontaneous venous pulsation will be recorded after a one minute fundoscopy observation.
- Oximetry reading in the non-contact retinal oximetry of the first 3 order retinal vessels
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Correlation Between Retinal Metabolism and the Observation of a Visible Retinal Spontaneous Venous Pulse|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
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
- Retinal Oxygen saturation in retinal veins with absent pulsation [ Time Frame: Up to 3 months ]We will assess, through analysing the oximetry recordings from both pulsating and non-pulsating retinal veins, whether there are any differences in venous or arterial-venous oxygen saturation in primary open-angle glaucoma patients
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): NCT01794442
|Leuven, Vlaams-Brabant, Belgium, 3000 Leuven|
|Contact: Luis Pinto, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Ingeborg Stalmans, MD, PhD|
|Sub-Investigator: Evelien Vandewalle, MD, PhD|
|Sub-Investigator: Luis Pinto, MD, PhD|
|Principal Investigator:||Ingeborg Stalmans, ND, PhD||UZ Leuven|