NCT00818233

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

First QC Date

November 18, 2008

Last Update Submit

May 11, 2016

Conditions

Intraocular Pressure

Keywords

dynamic contour tonometryvariabilitypulse amplitudeOcular pulse amplitude

Outcome Measures

Primary Outcomes (1)

  • The variability of intraocular pressure measurements using dynamic contour tonometry

    Same day

Secondary Outcomes (1)

  • Observe how pulse amplitude, as measured by dynamic contour tonometry, correlates with the difference in systolic and diastolic blood pressures

    Same day

Study Arms (1)

Observation

Variability will be assessed between each examiner.

Device: Dynamic contour tonometry

Interventions

Dynamic contour tonometryDEVICE

Observe variability of measurements by dynamic contour tonometry

Also known as: PASCAL tonometry, DCT
Observation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy, competent adults with normal, healthy eyes.

You may qualify if:

  • Normal, healthy eyes
  • Minimal to moderate refractive error
  • Willingness to participate in the study

You may not qualify if:

  • Diagnosis of any type of glaucoma
  • Any prior ocular surgery
  • Any prior ocular trauma
  • Any known anterior segment pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Eye Center

New Haven, Connecticut, 06510, United States

Location

Study Officials

  • Hylton R Mayer, MD

    Yale University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2008

First Posted

January 7, 2009

Study Start

January 1, 2009

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

US(1)