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Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

22. oktober 2014 opdateret af: University of Arkansas

Comparison of Keratometric Tear Break Up Time (KTBUT) to Fluorescein Tear Break Up Time (FTBUT)

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.

Studieoversigt

Status

Afsluttet

Betingelser

Tørre øjne

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Jones Eye Institute, University of Arkansas for Medical Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: Kun etui
Tidsperspektiver: Fremadrettet

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Difference Between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT) Tidsramme: 1 day	This outcome measures the difference in tear break up time using a keratometer and fluorescein dye.	1 day

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Ocular Surface Disease Index (OSDI) Questionnaire Tidsramme: 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.	1 week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Arkansas

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2009

Primær færdiggørelse (Faktiske)

1. juni 2009

Studieafslutning (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først indsendt

2. marts 2009

Først indsendt, der opfyldte QC-kriterier