Study on the Oxygen Saturation in Pulsating and Non-pulsating Central Retinal Veins
| Tracking Information | |||||
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| First Received Date ICMJE | February 12, 2013 | ||||
| Last Updated Date | June 12, 2013 | ||||
| Start Date ICMJE | January 2013 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Retinal Oxygen saturation in retinal veins with absent pulsation [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01794442 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study on the Oxygen Saturation in Pulsating and Non-pulsating Central Retinal Veins | ||||
| Official Title ICMJE | Correlation Between Retinal Metabolism and the Observation of a Visible Retinal Spontaneous Venous Pulse | ||||
| Brief Summary | 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 |
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| Detailed Description |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | primary care clinic |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | October 2013 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01794442 | ||||
| Other Study ID Numbers ICMJE | S120213 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Universitaire Ziekenhuizen Leuven | ||||
| Study Sponsor ICMJE | Universitaire Ziekenhuizen Leuven | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Universitaire Ziekenhuizen Leuven | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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