- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00818233
Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.
May 11, 2016 updated by: Yale University
The aim of the protocol is to document intra-observer and inter-observer variability with dynamic contour tonometry, and will also test the theory that pulse amplitude, as measured by dynamic contour tonometry, is correlated with the difference in systolic and diastolic blood pressures.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale Eye Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy, competent adults with normal, healthy eyes.
Description
Inclusion Criteria:
- Normal, healthy eyes
- Minimal to moderate refractive error
- Willingness to participate in the study
Exclusion Criteria:
- Diagnosis of any type of glaucoma
- Any prior ocular surgery
- Any prior ocular trauma
- Any known anterior segment pathology
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observation
Variability will be assessed between each examiner.
|
Observe variability of measurements by dynamic contour tonometry
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The variability of intraocular pressure measurements using dynamic contour tonometry
Time Frame: Same day
|
Same day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Observe how pulse amplitude, as measured by dynamic contour tonometry, correlates with the difference in systolic and diastolic blood pressures
Time Frame: Same day
|
Same day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hylton R Mayer, MD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Study Registration Dates
First Submitted
November 18, 2008
First Submitted That Met QC Criteria
January 6, 2009
First Posted (Estimate)
January 7, 2009
Study Record Updates
Last Update Posted (Estimate)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 11, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 0601001047
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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