Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dry Eye

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Keratometric Tear Breakup Time<br>These are the study participants whose tear break up times were measured with a keratometer. | |
| Fluorescein Break Up Time<br>These are the study participants whose tear break up times were measured with with fluorescein dye. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, keratometer, fluorescein