Clinical Trials Directory

Trials / Completed

CompletedNCT01496482

Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

Status
Completed
Phase
Study type
Observational
Enrollment
90 (actual)
Sponsor
University of Zagreb · Academic / Other
Sex
All
Age
18 Years – 61 Years
Healthy volunteers
Accepted

Summary

Purpose: To establish whether there is a correlation between dry eye symptoms, age and gender, a difference in symptom intensity in different times of the day, which test (Schirmer or TBUT) better correlates with dry eye symptoms, whether it is possible to reliably use cheap, easy to use hygrometer in everyday clinical setting, and finally whether there is statistically significant correlation between applied tests (TBUT, Schirmer and evaporimetry). Methods: Subjects: 45 in group without dry eye related symptoms, and 45 in group with symptoms. Examination included structured case history (questionnaire), slit lamp examination with fluorescein staining, periocular evaporimetry, TBUT test and Schirmer test.

Detailed description

Purpose: The purpose of this study was to establish whether there is a correlation between dry eye symptoms, age and gender, any difference in symptom intensity in different times of the day, which test (Schirmer or TBUT) better correlates with dry eye symptoms, whether it is possible to reliably use cheap, easy to use hygrometer in everyday clinical setting, and, finally, whether there is statistically significant correlation between applied tests (TBUT, Schirmer and evaporimetry). Methods: Subjects were divided in two groups: 45 in group without dry eye related symptoms, and 45 in group with symptoms. Examination was performed in the following sequence: 1. structured case history (questionnaire), 2. evaporimetry 3. slit lamp examination with fluorescein staining, 4. TBUT test and 5. Schirmer test I (without anesthetic, closed eyes) Case history consisted of the following questions:irritation more pronounced on wind? irritation during reading and/or watching TV or computer? irritation more pronounced during winter? gritty sensation in the eyes? irritation more pronounced in the morning or evening? All answers, except to the last question, were graded from 0 (no complaints) to 3 (severe). Evaporimetry was performed using commercially available hygrometer from HYGROTEC (Titisee-Neustadt, Germany), installed in swimming goggles with its front part sawn off. First measurement was performed by measuring for 5 minutes with eyes closed. Second measurement also lasted 5 minutes, with eyes kept open, normal blinking, and with subject fixating at one point in distance, with no eye movements. Measured parameters included: basal φ (%): relative environment humidity before measurement basal T: environment temperature before measurement closed eye φ (%): relative humidity in front of closed eye open eye φ (%): relative humidity in front of open eye C/O: ratio of φ (%) closed/open eye

Conditions

Interventions

TypeNameDescription
OTHEROnly measurements done on subjects in both groups.As study compared specific diagnostic procedures, no intervention was done or compared.

Timeline

Start date
2008-09-01
Primary completion
2009-02-01
Completion
2009-02-01
First posted
2011-12-21
Last updated
2011-12-22

Locations

1 site across 1 country: Croatia

Source: ClinicalTrials.gov record NCT01496482. Inclusion in this directory is not an endorsement.