Dry Eye SyndromesNCT01496482
Comparison of Evaporimetry With the Established Methods of Tear Film Measurement
An observational study of Dry Eye Syndromes, run by University of Zagreb at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Only measurements done on subjects in both groups.
- How many people
- 90 participants
- Where
- 1 siteCroatia
- Study dates
- Sep 2008to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- patients with or without dry eye symptoms
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the 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
- Conditions
- Dry Eye Syndromes
- Being tested
- Only measurements done on subjects in both groups.
- Keywords
- Dry eye Syndromes
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Only measurements done on subjects in both groups.Other
As study compared specific diagnostic procedures, no intervention was done or compared.
| Study group | Role | What they receive |
|---|---|---|
| Patients without dry eye symptoms | Patients without dry eye symptoms as measured by standard questionnaire. Receives: Other: Only measurements done on subjects in both groups. | |
| Patients with dry eye symptoms | Patients with dry eye symptoms as measured by standard questionnaire. Receives: Other: Only measurements done on subjects in both groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear evaporation
Five minutes of tear evaporation measurement with eyes closed and five with open, normal blinking.
Measured: 10 minutes
Secondary outcomes (5)
Comparison of tear evaporation to symptoms score
Tear evaporation measurement compared to dry eye symptoms score (0-15 points).
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 11 minutes (10 minutes evaporation measurement, 1 minute conjunctival hyperemia assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startSep 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Petricek, University of Zagreb
- Investigators
- Igor Petricek, MD, PhD, Principal investigator, Zagreb University Hospital Eye Department, Zagreb, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496482
- Sponsor's protocol ID
- UZagreb Eye 1
- Other IDs
- Dry Eye 1
- Status last verified
- Dec 2011
- First submitted
- 3 Dec 2011
- Last updated
- 22 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Evaporimetry With the Established Methods of Tear Film Measurement
- ClinicalTrials.gov ID
- NCT01496482
- Acronym / sponsor ID
- UZagreb Eye 1
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry eye Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without dry eye symptoms | – | Other: Only measurements done on subjects in both groups.Patients without dry eye symptoms as measured by standard questionnaire. |
| Patients with dry eye symptoms | – | Other: Only measurements done on subjects in both groups.Patients with dry eye symptoms as measured by standard questionnaire. |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- patients with or without dry eye symptoms
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Only measurements done on subjects in both groups.As study compared specific diagnostic procedures, no intervention was done or compared. | Other | Patients with dry eye symptoms, Patients without dry eye symptoms |
Primary outcome
Tear evaporation
Time frame: 10 minutes
Five minutes of tear evaporation measurement with eyes closed and five with open, normal blinking.
5 secondary outcomes
Comparison of tear evaporation to symptoms score
Time frame: 15 minutes (10 minutes tear evaporation, 5 minutes symptoms score recording)
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 Schirmer test
Time frame: 15 minutes (10 minutes tear evaporation measurement, 5 minutes Schirmer test)
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 conjunctival hyperemia
Time frame: 11 minutes (10 minutes evaporation measurement, 1 minute conjunctival hyperemia assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Petricek, MD, PhD principal investigator
Zagreb University Hospital Eye Department, Zagreb, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndromes, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear evaporation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2011.