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Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01496482
Enrollment
90
Registered
2011-12-21
Start date
2008-09-30
Completion date
2009-02-28
Last updated
2011-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Keywords

Dry eye Syndromes

Brief 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

Interventions

OTHEROnly measurements done on subjects in both groups.

As study compared specific diagnostic procedures, no intervention was done or compared.

Sponsors

University of Zagreb
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 61 Years
Healthy volunteers
Yes

Inclusion criteria

* patients with or without dry eye symptoms

Exclusion criteria

* minors * 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.

Design outcomes

Primary

MeasureTime frameDescription
Tear evaporation10 minutesFive minutes of tear evaporation measurement with eyes closed and five with open, normal blinking.

Secondary

MeasureTime frameDescription
Comparison of tear evaporation to symptoms score15 minutes (10 minutes tear evaporation, 5 minutes symptoms score recording)Tear evaporation measurement compared to dry eye symptoms score (0-15 points).
Comparison of tear evaporation to Tear Film Break-up Time (TBUT)15 minutes (10 minutes evaporation measurement, 5 minutes TBUT measurement)Comparison of tear evaporation to Tear Film Break-up Time (seconds).
Comparison of tear evaporation to Schirmer test15 minutes (10 minutes tear evaporation measurement, 5 minutes Schirmer test)Comparison of tear evaporation to Schirmer test (mm)
Comparison of tear evaporation to corneal staining12 minutes (10 minutes tear evaporation measurements, 2 minutes corneal staining assessment)Comparison of tear evaporation to corneal staining using fluorescein (score 1-3): 1:5-10 corneal stains at six o'clock; 2: 10-25 corneal stains; 3: more than 26 diffuse corneal stains
Comparison of tear evaporation to conjunctival hyperemia11 minutes (10 minutes evaporation measurement, 1 minute conjunctival hyperemia assessment)Comparison of tear evaporation to conjunctival hyperemia (score 1-3): 1: minimal; 2: moderate; 3: severe

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026