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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
History of Changes
  Purpose

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.


Condition Intervention
Dry Eye Syndromes
 Other: Only measurements done on subjects in both groups.

Study Type: Observational
Official Title: Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zagreb:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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



Enrollment: 90
Study Start Date: September 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients without dry eye symptoms
Patients without dry eye symptoms as measured by standard questionnaire.
 Other: Only measurements done on subjects in both groups.
As study compared specific diagnostic procedures, no intervention was done or compared.
Patients with dry eye symptoms
Patients with dry eye symptoms as measured by standard questionnaire.
 Other: Only measurements done on subjects in both groups.
As study compared specific diagnostic procedures, no intervention was done or compared.

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

Ages Eligible for Study:   18 Years to 61 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496482

Locations
Croatia
Zagreb University Hospital Eye Department
Zagreb, Croatia, HR-10000
Sponsors and Collaborators
University of Zagreb
Investigators
Principal Investigator: Igor Petricek, MD, PhD Zagreb University Hospital Eye Department, Zagreb, Croatia
  More Information

No publications provided

Responsible Party: Igor Petricek, Ophthalmologist, MD, PhD, Head of the Ocular Electrophysiology and Ultrasound Laboratory, University of Zagreb
ClinicalTrials.gov Identifier: NCT01496482     History of Changes
Other Study ID Numbers: UZagreb Eye 1, Dry Eye 1
Study First Received: December 3, 2011
Last Updated: December 21, 2011
Health Authority: Croatia: Ethics Committee

Keywords provided by University of Zagreb:
Dry eye Syndromes

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on May 23, 2013