System for Ocular Oxygen Measurement

This study has been withdrawn prior to enrollment.
(I withdrew from this study)
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT01229488
First received: October 26, 2010
Last updated: March 25, 2015
Last verified: March 2015
  Purpose

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
Normal
Device: Intervention

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 ]

Enrollment: 0
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)
Arms Assigned Interventions
No Intervention: No Arms
Project was withdrawn before starting
Device: Intervention
Project was withdrawn before starting. There were no interventions

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01229488

Locations
United States, Indiana
Indiana University School of Optometry
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Indiana University
  More Information

No publications provided

Responsible Party: Joseph A. Bonanno, Indiana University
ClinicalTrials.gov Identifier: NCT01229488     History of Changes
Other Study ID Numbers: 1006001474 IND
Study First Received: October 26, 2010
Last Updated: March 25, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 31, 2015