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: January 25, 2011
Last verified: January 2011
  Purpose

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.


Condition
Dry Eye

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Keratometric Tear Break Up Time (KTBUT) to Fluorescein Tear Break Up Time (FTBUT)

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 26
Study Start Date: February 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  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: NCT00854906

Locations
United States, Arkansas
Jones Eye Institute, University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
  More Information

No publications provided

Responsible Party: Richard Harper, MD, Department of Ophthalmology, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00854906     History of Changes
Other Study ID Numbers: 109338
Study First Received: March 2, 2009
Results First Received: July 7, 2010
Last Updated: January 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
dry eye
keratometer
fluorescein

Additional relevant MeSH terms:
Fluorescein
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014