Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

System for Ocular Oxygen Measurement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Indiana University.
Recruitment status was  Not yet recruiting
Information provided by:
Indiana University Identifier:
First received: October 26, 2010
Last updated: June 21, 2011
Last verified: July 2011

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.

Condition Intervention
Other: Test new Occumetrics Oximeter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science

Resource links provided by NLM:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 5
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Test new Occumetrics Oximeter
    Test tear oxygen level under select FDA approved contact lenses

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:


Exclusion Criteria:

  • contact lens wear in last 6 weeks
  • Use of topical drugs
  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 identifier: NCT01229488

Contact: Joseph A Bonanno

United States, Indiana
Indiana University School of Optometry Not yet recruiting
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Indiana University
  More Information

No publications provided

Responsible Party: Joseph A. Bonanno, Indiana University Identifier: NCT01229488     History of Changes
Other Study ID Numbers: 1006001474 IND
Study First Received: October 26, 2010
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration processed this record on March 02, 2015