Status:
COMPLETED
A New View of Normal Tension Glaucoma: Autoregulation and Systemic Blood Pressure
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Normal Tension Glaucoma
Eligibility:
All Genders
21-101 years
Brief Summary
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 w...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- The IOP must be less than or equal to 21 mmHg without treatment and must have never been higher than 24 mmHg, without treatment.
- Gonioscopically open angles.
- Typical glaucomatous optic disc changes, including: rim thinning, cupping, rim notching, disc hemorrhage, nerve fiber layer defect, vertical cup/disc asymmetry ≥0.2.
- A reproducible visual field defect must have been demonstrated on at least three prior visual fields, as observed using standard automated perimetry with Swedish Interactive Threshold Algorithm (SITA-STANDARD) from the Humphrey Visual Field Analyzer using the 24-2 test pattern.
- There must have been progression of glaucomatous loss with the past 36 months, specifically, two or more adjacent non-peripheral points changed by 10dB relative to the average baseline value for the points, confirmed by two subsequent fields.
Exclusion
- Subjects with a visual field defect attributable to conditions other than glaucoma, such as a history of intra-cranial or ENT mass lesion.
- Occludable narrow angles.
- Subjects with intermittent elevation of intraocular pressure associated with another form of glaucoma, including intermittent angle closure, inflammatory glaucoma, old pigmentary glaucoma, psedoexfoliation or uveitis.
- Subjects who cannot complete follow-up testing every six months for any reason.
- Subjects who are unable to provide informed consent or who refuse or whose physicians do not wish for the subjects to participate for any reason.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00706056
Start Date
September 1 2008
End Date
September 1 2011
Last Update
February 23 2017
Active Locations (2)
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1
Glaucoma Associates of New York/New York Eye and Ear Infirmary
New York, New York, United States, 10003
2
The New York Presbyterian Hospital-Weill Medical Center
New York, New York, United States, 10065