System for Ocular Oxygen Measurement
This study is not yet open for participant recruitment.
Verified July 2011 by Indiana University
Sponsor:
Indiana University
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT01229488
First received: October 26, 2010
Last updated: June 21, 2011
Last verified: July 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 26, 2010 | ||||
| Last Updated Date | June 21, 2011 | ||||
| Start Date ICMJE | July 2012 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
oxygen tension measurement by new device is comparable with gold standard, but less variable and faster. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01229488 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | System for Ocular Oxygen Measurement | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
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| Condition ICMJE | Normal | ||||
| Intervention ICMJE | Other: Test new Occumetrics Oximeter
Test tear oxygen level under select FDA approved contact lenses |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 5 | ||||
| Estimated Completion Date | July 2013 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01229488 | ||||
| Other Study ID Numbers ICMJE | 1006001474 IND | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joseph A. Bonanno, Indiana University | ||||
| Study Sponsor ICMJE | Indiana University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Indiana University | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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