Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Igor Petricek, University of Zagreb
ClinicalTrials.gov Identifier:
NCT01496482
First received: December 3, 2011
Last updated: December 21, 2011
Last verified: December 2011

December 3, 2011
December 21, 2011
September 2008
February 2009   (final data collection date for primary outcome measure)
Tear evaporation [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
Five minutes of tear evaporation measurement with eyes closed and five with open, normal blinking.
Same as current
Complete list of historical versions of study NCT01496482 on ClinicalTrials.gov Archive Site
  • Comparison of tear evaporation to symptoms score [ Time Frame: 15 minutes (10 minutes tear evaporation, 5 minutes symptoms score recording) ] [ Designated as safety issue: No ]
    Tear evaporation measurement compared to dry eye symptoms score (0-15 points).
  • Comparison of tear evaporation to Tear Film Break-up Time (TBUT) [ Time Frame: 15 minutes (10 minutes evaporation measurement, 5 minutes TBUT measurement) ] [ Designated as safety issue: No ]
    Comparison of tear evaporation to Tear Film Break-up Time (seconds).
  • Comparison of tear evaporation to Schirmer test [ Time Frame: 15 minutes (10 minutes tear evaporation measurement, 5 minutes Schirmer test) ] [ Designated as safety issue: No ]
    Comparison of tear evaporation to Schirmer test (mm)
  • Comparison of tear evaporation to corneal staining [ Time Frame: 12 minutes (10 minutes tear evaporation measurements, 2 minutes corneal staining assessment) ] [ Designated as safety issue: No ]

    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 [ Time Frame: 11 minutes (10 minutes evaporation measurement, 1 minute conjunctival hyperemia assessment) ] [ Designated as safety issue: No ]

    Comparison of tear evaporation to conjunctival hyperemia (score 1-3):

    1: minimal; 2: moderate; 3: severe

Same as current
Not Provided
Not Provided
 
Comparison of Evaporimetry With the Established Methods of Tear Film Measurement
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.

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

Observational
Not Provided
Not Provided
Not Provided
Non-Probability Sample

Patients were volunteers who came for a standard ophthalmological exam in Zagreb University Hospital Eye Clinic, and whose enrollment was based on convenience sampling.

Dry Eye Syndromes
Other: Only measurements done on subjects in both groups.
As study compared specific diagnostic procedures, no intervention was done or compared.
  • Patients without dry eye symptoms
    Patients without dry eye symptoms as measured by standard questionnaire.
    Intervention: Other: Only measurements done on subjects in both groups.
  • Patients with dry eye symptoms
    Patients with dry eye symptoms as measured by standard questionnaire.
    Intervention: Other: Only measurements done on subjects in both groups.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 61 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Croatia
 
NCT01496482
UZagreb Eye 1, Dry Eye 1
No
Igor Petricek, University of Zagreb
University of Zagreb
Not Provided
Principal Investigator: Igor Petricek, MD, PhD Zagreb University Hospital Eye Department, Zagreb, Croatia
University of Zagreb
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP