A New View of Normal Tension Glaucoma: Autoregulation and Systemic Blood Pressure
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | June 25, 2008 | ||||
| Last Updated Date | January 3, 2011 | ||||
| Start Date ICMJE | September 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
The primary outcome of the study will be visual field abnormalities and their relationship to dips in systemic blood pressure. [ Time Frame: baseline, 6-months and 12-months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00706056 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 | A New View of Normal Tension Glaucoma: Autoregulation and Systemic Blood Pressure | ||||
| Official Title ICMJE | A New View of Normal Tension Glaucoma: Autoregulation and Systemic Blood Pressure | ||||
| Brief Summary | Glaucoma is an eye disease that leads to damage of the optic nerve, visual field loss and can progress to blindness. Traditionally, glaucoma and its treatment have been closely linked to intraocular pressures. In normal tension glaucoma, damage to the optic nerve occurs without any increase in intraocular pressure. Normal tension glaucoma most often occurs in the elderly and can lead to loss of sight and significant disability. Subjects with progressive visual field loss are often a highly motivated group of subjects, ready to take an active part in the treatment of their condition. Investigating the risk factors that contribute to the development of normal-tension glaucoma may shed light on the progression of the disease. The objective of this study is to determine whether systemic blood pressure in the body is related to the development and progression of normal tension glaucoma in the eye. The study aims to clarify whether subjects with episodes of hypotension (low blood pressure) at night are at increased risk for sight loss and the development of normal tension glaucoma. Subjects with normal tension glaucoma will have their demographic and clinical characteristics recorded and their eyes examined at baseline, 6-months and 12 months. Subjects will wear an external blood pressure cuff for 48 hours that will record blood pressure every 30 minutes. This same blood pressure recording procedure will be performed at baseline, at 6 months, and at 12 months. At these same time intervals, visual fields will also be measured, as per routine clinical care, by the treating ophthalmologist. The results of the visual field testing will be recorded. The primary outcome of the study will be visual field abnormalities and their relationship to dips in systemic blood pressure. Results will be published and will be used as a base for future projects that may impact treatment and the understanding of risk factors of normal tension glaucoma. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with Normal Tension Glaucoma |
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| Condition ICMJE | Normal Tension Glaucoma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1
Patients with Normal-Tension Glaucoma |
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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 | 85 | ||||
| Estimated Completion Date | January 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00706056 | ||||
| Other Study ID Numbers ICMJE | 0712009565 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Mary E. Charlson, MD, Weill Cornell Medical College | ||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Weill Medical College of Cornell University | ||||
| Verification Date | January 2011 | ||||
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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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