N/A N=26

Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT00854906 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2011

Primary outcome: Primary: 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

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Arkansas
Primary completion: Jun 2009

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

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.

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.

View full record on ClinicalTrials.gov →

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.