N/A
Completed N=26
Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time
Source: ClinicalTrials.gov NCT00854906 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcomePrimary: Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT) — 5.95; 5.39 time in seconds — p=0.074
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT) |
5.95; 5.39 | 0.074 |
| SECONDARY Ocular Surface Disease Index (OSDI) Questionnaire |
9.4 | 0.093 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00854906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.