Plain English Summary
Background and study aims:
This study investigates whether the diagnosis of dry eyes and the determination of the degree of severity of dry eyes can be improved by taking measurements with a new type of device in addition to the usual examination. This device determines several values that are important for assessing the severity of dry eyes. This could specify and accelerate the diagnosis of dry eyes in the future.
Who can participate?
Anyone who is likely to have dry eyes (typical symptoms) can take part. Healthy test subjects can also take part, whose data will serve as comparison values. All participants must have signed the declaration of consent beforehand. Persons who are not yet of legal age or who are subject to guardianship are not allowed to participate. Pregnant and breastfeeding women are also not allowed to participate.
What does the study involve?
Participants will first be asked some general health questions. A questionnaire will also be filled out, to record the possible symptoms of dry eyes. This study will include people in the study who either show the typical symptoms of dry eyes or have no symptoms at all (control subjects).
Further measurements will be carried out during an ophthalmological consultation if participants have the typical symptoms of dry eyes. First, the data is recorded with a new device. Then the measurements will be made using conventional methods.
The data generated by the new device can be compared with those from the conventional investigation methods.
What are the possible benefits and risks of participating?
Participating in this study means that additional examinations will be carried out on attendees. Those examinations may be able to address and describe the possible problem of dry eyes more precisely.
Participation in this study is not associated with any additional risks. The light used is comparable to the slit lamp examination and can be felt to be somewhat bright.
Where is the study run from?
The Eye Clinic of Lucerne Cantonal Hospital (Switzerland)
When is the study starting and how long is it expected to run for?
From November 2020 to December 2021
Who is funding the study?
The Eye Clinic of Lucerne Cantonal Hospital (Switzerland)
Who is the main contact?
Dr Philipp B. Bänninger
philipp.baenninger@luks.ch
Trial website
Contact information
Type
Scientific
Primary contact
Dr Philipp B. Bänninger
ORCID ID
https://orcid.org/0000-0001-8118-2464
Contact details
Eye Clinic of Lucerne Cantonal Hospital (Augenklinik des Luzerner Kantonsspitals)
Spitalstrasse
Lucerne 16
6000
Switzerland
+41 41 205 34 10
philipp.baenninger@luks.ch
Type
Public
Additional contact
Dr Philipp B. Bänninger
ORCID ID
https://orcid.org/0000-0001-8118-2464
Contact details
Eye Clinic of Lucerne Cantonal Hospital (Augenklinik des Luzerner Kantonsspitals)
Spitalstrasse
Lucerne 16
6000
Switzerland
+41 41 205 34 10
philipp.baenninger@luks.ch
Type
Scientific
Additional contact
Mr Janosch Rinert
ORCID ID
http://orcid.org/0000-0003-2616-0291
Contact details
Eye Clinic of Lucerne Cantonal Hospital (Augenklinik des Luzerner Kantonsspitals)
Spitalstrasse
Lucerne 16
6000
Switzerland
+41 79 575 71 61
janosch.rinert@luks.ch
Type
Public
Additional contact
Mr Janosch Rinert
ORCID ID
http://orcid.org/0000-0003-2616-0291
Contact details
Eye Clinic of Lucerne Cantonal Hospital (Augenklinik des Luzerner Kantonsspitals)
Spitalstrasse
Lucerne 16
6000
Switzerland
+41 79 575 71 61
janosch.rinert@luks.ch
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2020-002
Study information
Scientific title
Evaluation of non-invasive automatic measurement protocol for dry eye diagnosis in patients with dry eye disease and control subjects
Acronym
DED trial
Study hypothesis
Accuracy of dry eye disease diagnosis is improved by applying a new automated non-invasive measurement protocol (IDRA system, SBM Sistemi, Turin, Italy) as compared to routine diagnostic procedures.
Ethics approval
Pending, Ethikkommission Nordwest- und Zentralschweiz (EKNZ) (Hebelstrasse 53, 4056 Basel, Switzerland; +41 61 268 13 50; eknz@bs.ch), ref: 2020-02648
Study design
Single-centre cross-sectional diagnostic accuracy study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Dry eye syndrome, dry eye disease
Intervention
Tear film condition will be explored in both patients showing dry eye disease (DED) symptoms and control subjects. Non-invasive tear film break-up time, tear meniscus height, lipid layer interferometry, eye blink quality, and infrared meibography will be measured using the IDRA system and compared to results from the established examination protocol (including Ocular Surface Disease Index©, tear film break-up time, biomicroscopic slit lamp examination, meibomian dysfunction testing, corneal staining, and Schirmer's test). Participants will be examined for a total duration of 50 min.
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. Classification performance (the proportion of subjects with dry eye disease correctly classified with a positive index test result and the proportion of healthy subjects correctly classified with a positive index test result) measured using the IDRA system to assess non-invasive tear film break-up time (NIBUT) at a single time point
Secondary outcome measures
1. Classification performance of lipid layer interferometry measured using the IDRA system at a single time point
2. Classification performance of tear meniscus height measured using the IDRA system at a single time point
3. Classification performance of meibography measured using the IDRA system at a single time point
4. Classification performance of routine diagnostic procedures including tear film break-up time, biomicroscopic slit lamp examination, meibomian dysfunction testing, corneal staining, and Schirmer's test at a single time point
Overall trial start date
01/11/2020
Overall trial end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All participants:
1. Aged between 18 and 79 years
2. Given consent and signed the consent form declaration
Patients:
1. Ocular Surface Disease Index (OSDI©) score ≥13
2. At least one of the following:
2.1. Image result for tear break-up time (TBUT) of ≤10 sec
2.2. Corneal staining grading ≥grade II
2.3. Schirmer test ≤10 mm in 5 min
Control subjects:
1. OSDI© score <13
2. Absence of sensitivity to light, ocular grittiness, ocular pain or soreness, blurred vision, poor vision, and eye redness
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
35 patients, 31 control subjects
Participant exclusion criteria
1. Eyelid deformities or eyelid motility disorders (such as incomplete lid closure, entropium, ectropium, hordeola, or chalazia)
2. Previous ocular disease leaving sequelae or requiring current topical eye therapy
3. Active ocular allergy
4. Known hypersensitivity to sodium fluorescein or oxybuprocaine
5. LASIK or PRK surgery performed
6. Punctal plugs or cauterization within the past 30 days
7. Abormality of nasolacrimal drainage
8. Pregnancy or lactation
9. Systemic disease known to affect tear production or loss, diagnosed or being instable within the past 30 days
10. Started or changed dose of chronic systemic medication known to affect tear production within the past 30 days
11. Any eye drops within the past 8 h
12. Contact lens worn within the past 8 h
Recruitment start date
01/01/2021
Recruitment end date
30/06/2021
Locations
Countries of recruitment
Switzerland
Trial participating centre
Eye Clinic of Lucerne Cantonal Hospital (Augenklinik des Luzerner Kantonsspitals)
Luzerner Kantonsspital
Spitalstrasse
Lucerne 16
6000
Switzerland
Sponsor information
Organisation
Luzerner Kantonsspital
Sponsor details
Eye Clinic of Lucerne Cantonal Hospital (Augenklinik des Luzerner Kantonsspitals)
Spitalstrasse
Lucerne 16
6000
Switzerland
+41 41 205 33 09
michael.thiel@luks.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Luzerner Kantonsspital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The study protocol and individual participant data that underlie the results reported in the article, after deidentification will be available upon request to janosch.rinert@luks.ch. To gain access, data requestors will need to sign a data access agreement. Data will be available beginning 3 months and ending 5 years following article publication to researchers who provide a methodologically sound proposal for whom the analysis of the data will aid to achieve the aims of the approved proposal.
Intention to publish date
31/12/2021
Participant level data
Available on request
Basic results (scientific)
Publication list