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

This study has been withdrawn prior to enrollment.
(Difficulty recruiting patients. PI left research facility.)
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00818233
First received: November 18, 2008
Last updated: January 13, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Intraocular Pressure
Device: Dynamic contour tonometry

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.

Further study details as provided by Yale University:

Primary Outcome Measures:
  • The variability of intraocular pressure measurements using dynamic contour tonometry [ Time Frame: Same day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Observe how pulse amplitude, as measured by dynamic contour tonometry, correlates with the difference in systolic and diastolic blood pressures [ Time Frame: Same day ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observation
Variability will be assessed between each examiner.
Device: Dynamic contour tonometry
Observe variability of measurements by dynamic contour tonometry
Other Names:
  • PASCAL tonometry
  • DCT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy, competent adults with normal, healthy eyes.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818233

Locations
United States, Connecticut
Yale Eye Center
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Hylton R Mayer, MD Yale University
  More Information

No publications provided

Responsible Party: Hylton R. Mayer, Yale University
ClinicalTrials.gov Identifier: NCT00818233     History of Changes
Other Study ID Numbers: 0601001047
Study First Received: November 18, 2008
Last Updated: January 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
dynamic contour tonometry
variability
pulse amplitude
Ocular pulse amplitude

ClinicalTrials.gov processed this record on August 28, 2014