Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854906
• Other study ID #: 109338
• Status: Completed
• Phase: N/A
• First received: March 2, 2009
• Last updated: October 22, 2014
• Start date: February 2009
• Est. completion date: June 2009

Study information

• Verified date: October 2014
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye

Locations

Country	Name	City	State
United States	Jones Eye Institute, University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT)	This outcome measures the difference in tear break up time using a keratometer and fluorescein dye.	1 day	No
Secondary	Ocular Surface Disease Index (OSDI) Questionnaire	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.	1 week	No