A New View of Normal Tension Glaucoma: Autoregulation and Systemic Blood Pressure
Recruitment status was: Recruiting
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.
Normal Tension Glaucoma
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A New View of Normal Tension Glaucoma: Autoregulation and Systemic Blood Pressure|
- 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 ]
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||January 2011|
Patients with Normal-Tension Glaucoma
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706056
|United States, New York|
|Glaucoma Associates of New York/New York Eye and Ear Infirmary|
|New York, New York, United States, 10003|
|The New York Presbyterian Hospital-Weill Medical Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Mary E. Charlson, MD||Weill Medical College of Cornell University|