Normal Tension GlaucomaNCT00706056
A New View of Normal Tension Glaucoma: Autoregulation and Systemic Blood Pressure
An observational study of Normal Tension Glaucoma, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 101 years
- Conditions the study is for
- Normal Tension Glaucoma
- How many people
- 85 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 101 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Normal Tension Glaucoma
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Glaucoma Associates of New York/New York Eye and Ear Infirmary
New York, New York, 10003
The New York Presbyterian Hospital-Weill Medical Center
New York, New York, 10065
About this study
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.
Read the 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 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.
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.
- Conditions
- Normal Tension Glaucoma
- Medical subject headings
- Low Tension Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study will be visual field abnormalities and their relationship to dips in systemic blood pressure.
Measured: baseline, 6-months and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Tension GlaucomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary E. Charlson, MD, Weill Medical College of Cornell University
- Investigators
- Mary E. Charlson, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706056
- Sponsor's protocol ID
- 0712009565
- Status last verified
- Feb 2017
- First submitted
- 25 Jun 2008
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No Plan to Share IPD
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New View of Normal Tension Glaucoma: Autoregulation and Systemic Blood Pressure
- ClinicalTrials.gov ID
- NCT00706056
- Acronym / sponsor ID
- 0712009565
- Conditions
- Normal Tension Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 101 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Normal Tension Glaucoma
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No. No Plan to Share IPD
Related trials for Normal Tension Glaucoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E. Charlson, MD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Tension Glaucoma, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.