Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00818233
Recruitment Status : Withdrawn (Difficulty recruiting patients. PI left research facility.)
First Posted : January 7, 2009
Last Update Posted : May 13, 2016
Sponsor:
Information provided by:
Yale University

Tracking Information
First Submitted Date November 18, 2008
First Posted Date January 7, 2009
Last Update Posted Date May 13, 2016
Study Start Date January 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: January 6, 2009)
The variability of intraocular pressure measurements using dynamic contour tonometry [ Time Frame: Same day ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 6, 2009)
Observe how pulse amplitude, as measured by dynamic contour tonometry, correlates with the difference in systolic and diastolic blood pressures [ Time Frame: Same day ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.
Official Title Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy, competent adults with normal, healthy eyes.
Condition Intraocular Pressure
Intervention Device: Dynamic contour tonometry
Observe variability of measurements by dynamic contour tonometry
Other Names:
  • PASCAL tonometry
  • DCT
Study Groups/Cohorts Observation
Variability will be assessed between each examiner.
Intervention: Device: Dynamic contour tonometry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: January 13, 2011)
0
Original Estimated Enrollment
 (submitted: January 6, 2009)
15
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00818233
Other Study ID Numbers 0601001047
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hylton R. Mayer, Yale University
Study Sponsor Yale University
Collaborators Not Provided
Investigators
Principal Investigator: Hylton R Mayer, MD Yale University
PRS Account Yale University
Verification Date May 2016