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Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dry Eye

Phase: N/A

Status: Completed

Sponsored by: University of Arkansas


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.

Clinical Details

Official title: Comparison of Keratometric Tear Break Up Time (KTBUT) to Fluorescein Tear Break Up Time (FTBUT)

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT)

Secondary outcome: Ocular Surface Disease Index (OSDI) Questionnaire

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Jones Eye Institute, University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States
Additional Information

Starting date: February 2009
Last updated: October 22, 2014

Page last updated: August 20, 2015

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