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Completed

NCT Number: NCT01496482

Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

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.

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Key information

Age range

18 year–61 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zagreb University Hospital Eye Department

Zagreb, HR-10000, Croatia

About this study

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:

  • structured case history (questionnaire),
  • evaporimetry
  • slit lamp examination with fluorescein staining,
  • TBUT test and
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Only measurements done on subjects in both groups.

Other

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

Primary outcomes

  1. Tear evaporation

    Time frame: 10 minutes

    Five minutes of tear evaporation measurement with eyes closed and five with open, normal blinking.

Secondary outcomes

  1. Comparison of tear evaporation to symptoms score

    Time frame: 15 minutes (10 minutes tear evaporation, 5 minutes symptoms score recording)

    Tear evaporation measurement compared to dry eye symptoms score (0-15 points).

  2. Comparison of tear evaporation to Tear Film Break-up Time (TBUT)

    Time frame: 15 minutes (10 minutes evaporation measurement, 5 minutes TBUT measurement)

    Comparison of tear evaporation to Tear Film Break-up Time (seconds).

  3. Comparison of tear evaporation to Schirmer test

    Time frame: 15 minutes (10 minutes tear evaporation measurement, 5 minutes Schirmer test)

    Comparison of tear evaporation to Schirmer test (mm)

  4. Comparison of tear evaporation to corneal staining

    Time frame: 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

  5. Comparison of tear evaporation to conjunctival hyperemia

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 21, 2011
Registry last updated
Dec 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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