Clinical trial NCT01496482: Comparison of Evaporimetry With the Established Methods of Tear Film Measurement
Official title: Comparison of Evaporimetry With the Established Methods of Tear Film Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Keywords: Dry eye Syndromes
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were volunteers who came for a standard ophthalmological exam in Zagreb University Hospital Eye Clinic, and whose enrollment was based on convenience sampling.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Tear evaporation
timeFrame: 10 minutes
Secondary outcomes:
measure: Comparison of tear evaporation to symptoms score
timeFrame: 15 minutes (10 minutes tear evaporation, 5 minutes symptoms score recording)
measure: Comparison of tear evaporation to Tear Film Break-up Time (TBUT)
timeFrame: 15 minutes (10 minutes evaporation measurement, 5 minutes TBUT measurement)
measure: Comparison of tear evaporation to Schirmer test
timeFrame: 15 minutes (10 minutes tear evaporation measurement, 5 minutes Schirmer test)
measure: Comparison of tear evaporation to corneal staining
timeFrame: 12 minutes (10 minutes tear evaporation measurements, 2 minutes corneal staining assessment)
measure: Comparison of tear evaporation to conjunctival hyperemia
timeFrame: 11 minutes (10 minutes evaporation measurement, 1 minute conjunctival hyperemia assessment)
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Zagreb University Hospital Eye Department
Study officials:
affiliation: Zagreb University Hospital Eye Department, Zagreb, Croatia
name: Igor Petricek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: