System for Ocular Oxygen Measurement | NCT01229488

Studies
System for Ocular Oxygen Measurement

NCT01229488

Sponsor

Indiana University

Status

Withdrawn

Last Update Posted

Mar 26, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Normal

Interventions

Intervention

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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

I withdrew from this study

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2013Estimated

Completion Date

Jul 2013Estimated

First Submitted Date

Oct 26, 2010

First Submission Date that Met QC Criteria

Oct 26, 2010

First Posted Date

Oct 27, 2010Estimated

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

Mar 25, 2015

Last Update Posted Date

Mar 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to demonstrate the ability of the OcuMetrics system to measure oxygen on the surface of the eye. Oxygen is important to the health of the cornea. The proposed instrument will take advantage of phosphorescent dyes that are sensitive to oxygen concentrations to monitor oxygen concentrations on the surface of the eye. This will have obvious applications in eye research and contact lens testing.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Arms	No Intervention	Project was withdrawn before starting	Device: Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intervention	Device	Project was withdrawn before starting. There were no interventions	No Arms

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oxygen tension measurement by new device is comparable with gold standard, but less variable and faster.		2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

contact lens wear in last 6 weeks
Use of topical drugs

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University School of Optometry		Bloomington	Indiana	47405	United States