Testing of a new measurement procedure for dry eye diagnosis on patients and healthy subjects
| ISRCTN | ISRCTN61064041 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61064041 |
| Secondary identifying numbers | 2020-002 |
- Submission date
- 19/12/2020
- Registration date
- 24/12/2020
- Last edited
- 05/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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?
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@gmail.com
Contact information
Public, Scientific
Eye Clinic of Lucerne Cantonal Hospital (Augenklinik des Luzerner Kantonsspitals)
Spitalstrasse
Lucerne 16
6000
Switzerland
 ORCID ID |
0000-0001-8118-2464 |
|---|---|
| Phone | +41 41 205 34 10 |
| philipp.baenninger@gmail.com |
Public, Scientific
Eye Clinic of Lucerne Cantonal Hospital (Augenklinik des Luzerner Kantonsspitals)
Spitalstrasse
Lucerne 16
6000
Switzerland
| ORCID ID |
0000-0003-2616-0291 |
|---|---|
| Phone | +41 79 575 71 61 |
| janosch.rinert@bluewin.ch |
Study information
| Study design | Single-centre cross-sectional diagnostic accuracy study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Evaluation of non-invasive automatic measurement protocol for dry eye diagnosis in patients with dry eye disease and control subjects |
| Study acronym | DED trial |
| Study objectives | The 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(s) |
Approved 28/12/2020, Ethikkommission Nordwest- und Zentralschweiz (EKNZ) (Hebelstrasse 53, Basel, CH-4056, Switzerland; +41 61 268 13 51; eknz@bs.ch), ref: 2020-02648 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | IDRA system |
| 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 study start date | 01/11/2020 |
| Completion date | 04/05/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 35 patients, 31 control subjects |
| Total final enrolment | 75 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2021 |
| Date of final enrolment | 27/04/2021 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Spitalstrasse
Lucerne 16
6000
Switzerland
Sponsor information
Hospital/treatment centre
Eye Clinic of Lucerne Cantonal Hospital (Augenklinik des Luzerner Kantonsspitals)
Spitalstrasse
Lucerne 16
6000
Switzerland
| Phone | +41 41 205 33 09 |
|---|---|
| michael.thiel@luks.ch | |
| Website | https://www.luks.ch/ |
"ROR" |
https://ror.org/02zk3am42 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | 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@bluewin.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 in achieving the aims of the approved proposal. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 21/04/2022 | 29/06/2022 | Yes | No |
Editorial Notes
05/01/2024: The following changes were made:
1. Study contact email addresses were updated through the record.
2. Ethics approval date was added.
29/06/2022: Publication reference added.
13/12/2021: Total final enrolment added.
01/06/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 27/04/2021.
2. The overall trial end date has been changed from 31/12/2021 to 04/05/2021.
23/12/2020: Trial’s existence confirmed by Ethikkommission Nordwest- und Zentralschweiz.
