Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

NCT00854906 | Completed Results

• 1 other identifier: 109338
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

dry eye; keratometer; fluorescein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ocular Surface Disease Index (OSDI) Questionnaire

  1 week

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the Jones Eye Clinic, Department of Ophthalmology, University of Arkansas for Medical Sciences

You may qualify if:

• An adult, between ages 18-99
• An adult who is able to understand study instructions

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Jones Eye Institute, University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Richard Harper
• Organization: University of Arkansas for Medical Sciences

harperricharda@uams.edu

501 526-6000

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 3, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 23, 2014
• Results First Posted: January 25, 2011

Record last verified: 2014-10

Locations

US (1)