A New View of Normal Tension Glaucoma: Autoregulation and Systemic Blood Pressure

NCT00706056 | Completed

• 1 other identifier: 0712009565
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Normal Tension Glaucoma

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the study will be visual field abnormalities and their relationship to dips in systemic blood pressure.

  baseline, 6-months and 12-months

Eligibility Criteria

• Age: 21 Years - 101 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Normal Tension Glaucoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (2)

Glaucoma Associates of New York/New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

The New York Presbyterian Hospital-Weill Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Mary E. Charlson, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)