Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparison of Evaporimetry With the Established Methods of Tear Film Measurement

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Other: Only measurements done on subjects in both groups.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 61 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients without dry eye symptoms<br>Patients without dry eye symptoms as measured by standard questionnaire. | Other: Only measurements done on subjects in both groups.<br>* As study compared specific diagnostic procedures, no intervention was done or compared.<br>|
| Patients with dry eye symptoms<br>Patients with dry eye symptoms as measured by standard questionnaire. | Other: Only measurements done on subjects in both groups.<br>* As study compared specific diagnostic procedures, no intervention was done or compared.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear evaporation | Five minutes of tear evaporation measurement with eyes closed and five with open, normal blinking. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye Syndromes