Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Other: Only measurements done on subjects in both groups.

• Registration Number: NCT01496482
• Lead Sponsor: University of Zagreb

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

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2011-12
• Study First Submitted: 2011-12-03
• Study First Submitted QC: 2011-12-16
• Study First Posted: 2011-12-21
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients without dry eye symptoms	Only measurements done on subjects in both groups.	Patients without dry eye symptoms as measured by standard questionnaire.
Patients with dry eye symptoms	Only measurements done on subjects in both groups.	Patients with dry eye symptoms as measured by standard questionnaire.

Primary Outcome Measures

Name	Time	Method
Tear evaporation	10 minutes	Five minutes of tear evaporation measurement with eyes closed and five with open, normal blinking.

Secondary Outcome Measures

Name	Time	Method
Comparison of tear evaporation to symptoms score	15 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 test	15 minutes (10 minutes tear evaporation measurement, 5 minutes Schirmer test)	Comparison of tear evaporation to Schirmer test (mm)
Comparison of tear evaporation to corneal staining	12 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 hyperemia	11 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

Trial Locations

Locations (1)

Zagreb University Hospital Eye Department; 🇭🇷 Zagreb, Croatia