Intra-observer and Inter-observer Variability With Dynami... | NCT00818233

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

NCT00818233

Sponsor

Yale University

Status

Withdrawn

Last Update Posted

May 13, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Intraocular Pressure

Interventions

Dynamic contour tonometry

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty recruiting patients. PI left research facility.

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 18, 2008

First Submission Date that Met QC Criteria

Jan 6, 2009

First Posted Date

Jan 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2016

Last Update Posted Date

May 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observation		Variability will be assessed between each examiner.	Device: Dynamic contour tonometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dynamic contour tonometry	Device	Observe variability of measurements by dynamic contour tonometry	Observation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The variability of intraocular pressure measurements using dynamic contour tonometry		Same day

Secondary Outcomes

Measure	Description	Time Frame
Observe how pulse amplitude, as measured by dynamic contour tonometry, correlates with the difference in systolic and diastolic blood pressures		Same day

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy, competent adults with normal, healthy eyes.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hylton R Mayer, MD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale Eye Center		New Haven	Connecticut	06510	United States