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Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Locations
Croatia
Study Type
Observational
Intervention
Only measurements done on subjects in both groups.
Sponsored by
University of Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Dry Eye Syndromes focused on measuring Dry eye Syndromes

Eligibility Criteria

18 Years - 61 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Zagreb University Hospital Eye Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Patients without dry eye symptoms

Patients with dry eye symptoms

Arm Description

Patients without dry eye symptoms as measured by standard questionnaire.

Patients with dry eye symptoms as measured by standard questionnaire.

Outcomes

Primary Outcome Measures

Tear evaporation
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
Tear evaporation measurement compared to dry eye symptoms score (0-15 points).
Comparison of tear evaporation to Tear Film Break-up Time (TBUT)
Comparison of tear evaporation to Tear Film Break-up Time (seconds).
Comparison of tear evaporation to Schirmer test
Comparison of tear evaporation to Schirmer test (mm)
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
Comparison of tear evaporation to conjunctival hyperemia
Comparison of tear evaporation to conjunctival hyperemia (score 1-3): 1: minimal; 2: moderate; 3: severe

Full Information

First Posted
December 3, 2011
Last Updated
December 21, 2011
Sponsor
University of Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT01496482
Brief Title
Comparison of Evaporimetry With the Established Methods of Tear Film Measurement
Official Title
Comparison of Evaporimetry With the Established Methods of Tear Film Measurement
Study Type
Observational

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zagreb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Dry eye Syndromes

7. Study Design

Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients without dry eye symptoms
Arm Description
Patients without dry eye symptoms as measured by standard questionnaire.
Arm Title
Patients with dry eye symptoms
Arm Description
Patients with dry eye symptoms as measured by standard questionnaire.
Intervention Type
Other
Intervention Name(s)
Only measurements done on subjects in both groups.
Intervention Description
As study compared specific diagnostic procedures, no intervention was done or compared.
Primary Outcome Measure Information:
Title
Tear evaporation
Description
Five minutes of tear evaporation measurement with eyes closed and five with open, normal blinking.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Comparison of tear evaporation to symptoms score
Description
Tear evaporation measurement compared to dry eye symptoms score (0-15 points).
Time Frame
15 minutes (10 minutes tear evaporation, 5 minutes symptoms score recording)
Title
Comparison of tear evaporation to Tear Film Break-up Time (TBUT)
Description
Comparison of tear evaporation to Tear Film Break-up Time (seconds).
Time Frame
15 minutes (10 minutes evaporation measurement, 5 minutes TBUT measurement)
Title
Comparison of tear evaporation to Schirmer test
Description
Comparison of tear evaporation to Schirmer test (mm)
Time Frame
15 minutes (10 minutes tear evaporation measurement, 5 minutes Schirmer test)
Title
Comparison of tear evaporation to corneal staining
Description
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
Time Frame
12 minutes (10 minutes tear evaporation measurements, 2 minutes corneal staining assessment)
Title
Comparison of tear evaporation to conjunctival hyperemia
Description
Comparison of tear evaporation to conjunctival hyperemia (score 1-3): 1: minimal; 2: moderate; 3: severe
Time Frame
11 minutes (10 minutes evaporation measurement, 1 minute conjunctival hyperemia assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Study Population Description
Patients were volunteers who came for a standard ophthalmological exam in Zagreb University Hospital Eye Clinic, and whose enrollment was based on convenience sampling.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor Petricek, MD, PhD
Organizational Affiliation
Zagreb University Hospital Eye Department, Zagreb, Croatia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagreb University Hospital Eye Department
City
Zagreb
ZIP/Postal Code
HR-10000
Country
Croatia

12. IPD Sharing Statement

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Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

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