Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

NCT ID: NCT00854906

Last Updated: 2014-10-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-06-30

Brief Summary

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.

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.

Conditions

Dry Eye

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Keratometric Tear Breakup Time

These are the study participants whose tear break up times were measured with a keratometer.

No interventions assigned to this group

Fluorescein Break Up Time

These are the study participants whose tear break up times were measured with with fluorescein dye.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Department of Ophthalmology, University of Arkansas for Medical Sciences

Locations

Jones Eye Institute, University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

109338

Identifier Type: -

Identifier Source: org_study_id