Comparison of Evaporimetry With the Established Methods of Tear Film Measurement
NCT ID: NCT01496482
Last Updated: 2011-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2008-09-30
2009-02-28
Brief Summary
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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
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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
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Keywords
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Study Groups
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Patients without dry eye symptoms
Patients without dry eye symptoms as measured by standard questionnaire.
Only measurements done on subjects in both groups.
As study compared specific diagnostic procedures, no intervention was done or compared.
Patients with dry eye symptoms
Patients with dry eye symptoms as measured by standard questionnaire.
Only measurements done on subjects in both groups.
As study compared specific diagnostic procedures, no intervention was done or compared.
Interventions
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Only measurements done on subjects in both groups.
As study compared specific diagnostic procedures, no intervention was done or compared.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pregnant women
* patients with acute eye conditions (inflammation, allergy, trauma)
* patients with chronic eye diseases requiring continuous topical treatment (i.e.glaucoma)
* ocular surface scarring
* patients who did not sign informed consent.
18 Years
61 Years
ALL
Yes
Sponsors
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University of Zagreb
OTHER
Responsible Party
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Igor Petricek
Ophthalmologist, MD, PhD, Head of the Ocular Electrophysiology and Ultrasound Laboratory
Principal Investigators
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Igor Petricek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Zagreb University Hospital Eye Department, Zagreb, Croatia
Locations
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Zagreb University Hospital Eye Department
Zagreb, , Croatia
Countries
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Other Identifiers
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Dry Eye 1
Identifier Type: OTHER
Identifier Source: secondary_id
UZagreb Eye 1
Identifier Type: -
Identifier Source: org_study_id