Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00854906
First received: March 2, 2009
Last updated: October 22, 2014
Last verified: October 2014

March 2, 2009
October 22, 2014
February 2009
June 2009   (final data collection date for primary outcome measure)
Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
This outcome measures the difference in tear break up time using a keratometer and fluorescein dye.
The investigators believe the that keratometric tear break up time will be a better method of quantifying dry eye symptoms as compared to current clinical methods. These results are reasonably expected. [ Time Frame: one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00854906 on ClinicalTrials.gov Archive Site
Ocular Surface Disease Index (OSDI) Questionnaire [ Time Frame: 1 week ] [ Designated as safety issue: No ]
The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire used in dry eye studies. The OSDI Scale ranges from 0= Normal to 100= Severe. Subcategories include problems--all of the time, most of the time, half of the time,and none of the time.
Not Provided
Not Provided
Not Provided
 
Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time
Comparison of Keratometric Tear Break Up Time (KTBUT) to Fluorescein Tear Break Up Time (FTBUT)

The purpose of the research is to determine if putting fluorescein onto the eye (most common test done for dry eye syndrome) is an accurate way to measure dry eye symptoms. The investigators can avoid placing any foreign substance into the eye by using a manual keratometer. Therefore, the investigators want to compare the measurements of tear breakup time using fluorescein with using a novel method, a manual keratometer and then compare these measurements to a validated dry eye symptoms questionnaire. All qualifying patients who were scheduled in the Jones Eye Institute Clinics for a complete eye exam were offered information about the study and invited to participate. Participants were recruited from February 29, 2009 to April 14, 2009.Participants who did not meet the study protocol's inclusion and exclusion criteria were not included the study or study data analysis. All subjects eyes were measured for KTBUT and FTBUT.

This is an observational study to measure the difference between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT). All qualified study participants had their eyes measured for tear break up time measured with a keratometer and with fluorescein dye. In this study, we compare the use of the most common method, fluorescein dye, to measure tear break up time to a novel method, a keratometer, to measure tear break up time. Using the keratometer avoids instilling fluorescein dye into the tear film and not altering the tear film's physiologic environment.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients from the Jones Eye Clinic, Department of Ophthalmology, University of Arkansas for Medical Sciences

Dry Eye
Not Provided
  • Keratometric Tear Breakup Time
    These are the study participants whose tear break up times were measured with a keratometer.
  • Fluorescein Break Up Time
    These are the study participants whose tear break up times were measured with with fluorescein dye.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • An adult, between ages 18-99
  • An adult who is able to understand study instructions

Exclusion Criteria:

  • An adult with corneal pathology that prevents accurate assessment of keratometric or fluorescein tear break up time.
  • An adult with an allergy to fluorescein, a very common eye dye that detects defects in the cornea.
  • The inability to answer questions on your own.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00854906
109338
No
Richard Harper, MD, Department of Ophthalmology, University of Arkansas for Medical Sciences
University of Arkansas
Not Provided
Not Provided
University of Arkansas
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP