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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from the Jones Eye Clinic, Department of Ophthalmology, University of Arkansas for Medical Sciences
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jones Eye Institute, University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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 first for KTBUT and second for FTBUT. Each measurement occured three times in each eye and the results were recorded in seconds during their office visit and averaged.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). Both KTBUT and FTBUT were measured in all study participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). All study participants participated in both the KTBUT Study Arm and the FTBUT Study Arm. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of participants for analysis was determined if each participant met all of the study protocol's inclusion and exclusion criteria. KTBUT and FTBUT were measured on all study participants. | Posted | Jun 2010 | Mean | Standard Deviation | time in seconds | 1 day | eyes | Participants |
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The number of participants at risk were 0. Serious and/or other [non-serious] adverse events were not collected or assessed. The study only required subjects to participate one time. There were not any follow-up visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KTBUT | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Harper | University of Arkansas for Medical Sciences | 501 526-6000 | 2616 | harperricharda@uams.edu |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
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| Participants |
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| eyes |
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| 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. | By comparing the KTBUT and the FTBUT to the Ocular Surface Disease Index (OSDI) questionnaire score of each participant, we will be able to evaluate the difference in tear break up time using these items. The OSDI was given once before the participant's KTBUT and FTBUT was measured. | Posted | Mean | Standard Deviation | participants | 1 week |
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| 25 |
| 0 |
| 25 |
| EG001 | FTBUT | 0 | 25 | 0 | 25 |
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A correlation was performed between ODSI questionnaire results and each participant's FTBUT.
| Pearson's Correlation |
| 0.216 |
| Pearson's Correlation, r |
| -0.26 |
| No |
| Superiority or Other |