Dry Eye
Conditions
Keywords
dry eye, keratometer, fluorescein
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.
Interventions
None listed
Sponsors
University of Arkansas
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT) | 1 day | This outcome measures the difference in tear break up time using a keratometer and fluorescein dye. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI) Questionnaire | 1 week | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | One person had no ocular history | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 39.6 years STANDARD_DEVIATION 15.5 |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: 1 day
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KTBUT | Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT) | 5.95 time in seconds | Standard Deviation 2.8 |
| FTBUT | Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT) | 5.39 time in seconds | Standard Deviation 2.57 |
Comparison: The paired T-test was used to compare mean KTBUT and mean FTBUT.p-value: 0.07495% CI: [-0.069, 1.401]t-test, 2 sided
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.
Time frame: 1 week
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KTBUT | Ocular Surface Disease Index (OSDI) Questionnaire | 9.4 participants | Standard Deviation 9.1 |
Comparison: A correlation was performed between ODSI questionnaire results and each participant's KTBUT.p-value: 0.093Pearson's correlation
Comparison: A correlation was performed between ODSI questionnaire results and each participant's FTBUT.p-value: 0.216Pearson's Correlation