Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

Dry Eye Syndromes Clinical Trial

Official title:

Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01496482
• Other study ID #: UZagreb Eye 1
• Secondary ID: Dry Eye 1
• Status: Completed
• Phase: N/A
• First received: December 3, 2011
• Last updated: December 21, 2011
• Start date: September 2008
• Est. completion date: February 2009

Study information

• Verified date: December 2011
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 61 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Only measurements done on subjects in both groups.
As study compared specific diagnostic procedures, no intervention was done or compared.

Locations

Country	Name	City	State
Croatia	Zagreb University Hospital Eye Department	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear evaporation	Five minutes of tear evaporation measurement with eyes closed and five with open, normal blinking.	10 minutes	No
Secondary	Comparison of tear evaporation to symptoms score	Tear evaporation measurement compared to dry eye symptoms score (0-15 points).	15 minutes (10 minutes tear evaporation, 5 minutes symptoms score recording)	No
Secondary	Comparison of tear evaporation to Tear Film Break-up Time (TBUT)	Comparison of tear evaporation to Tear Film Break-up Time (seconds).	15 minutes (10 minutes evaporation measurement, 5 minutes TBUT measurement)	No
Secondary	Comparison of tear evaporation to Schirmer test	Comparison of tear evaporation to Schirmer test (mm)	15 minutes (10 minutes tear evaporation measurement, 5 minutes Schirmer test)	No
Secondary	Comparison of tear evaporation to corneal staining	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	12 minutes (10 minutes tear evaporation measurements, 2 minutes corneal staining assessment)	No
Secondary	Comparison of tear evaporation to conjunctival hyperemia	Comparison of tear evaporation to conjunctival hyperemia (score 1-3): 1: minimal; 2: moderate; 3: severe	11 minutes (10 minutes evaporation measurement, 1 minute conjunctival hyperemia assessment)	No