GlaucomaSALUSNCT04698876
Self Tonometry and Transfer of Glaucoma Patients' Data for Improving the Supply Situation
A study testing Self-tonometry by means of ICareHOME, Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry and Blood pressure in people with Glaucoma and Intraocular Pressure, run by University Hospital Muenster at 5 sites in Germany.
Trial summary
The SALUS project is developing a new form of care, the application of self-tonometry by the patient itself, and an accompanying electronic case file connecting clinics, doctor's offices and patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Intraocular Pressure, Patient Empowerment
- What is being tested?
- Self-tonometry by means of ICareHOME, Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry and Blood pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 5 sitesGermany
- Study dates
- 11 Feb 2021to 30 Nov 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requirement of a stationary day and night measurement
- Statutory health insurance
- Verified and suspicion of glaucoma diagnosis with suspicion of pressure variations and peaks or not attained target pressure or suspicion of glaucoma progression (H40.1, H40.2 und H42.-)
- Willingness for therapy in one of the participating clinics
- Adequate German language skills
- Signed and dated informed consent for study participation and data transfer
- Legal capacity of the insurant to agree to the study participation
Who cannot join
- Patients outside the catchment area of the participating clinics
- Covering illnesses in psychiatry, neurology or other indications (e.g. impairment of independence) which make self-tonometry impossible
- Strong communication barriers that do not allow the instruction to carry out the intervention
- Unclear legal capacity of the potential study participants
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Klinikum Dortmund
Dortmund
St.-Johannes-Hospital Dortmund
Dortmund
Kath. Krankenhaus Hagen, St.-Josefs-Hospital
Hagen
Klinikum Luedenscheid
Lüdenscheid
University Hospital Muenster
Münster
About this study
Official title: SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation
The SALUS project is developing a new form of care, the application of self-tonometry by the patient itself, and an accompanying electronic case file connecting clinics, doctor's offices and patients.
Read the detailed description
The SALUS project is developing an outpatient, intersectoral form of care in which patients measure their intraocular pressure in their home environment with a so-called self-tonometer. The measured intraocular pressure values are incorporated into daily pressure profiles, which can be viewed via an electronic case file together with further examination data both by the treating ophthalmologists in the doctor's offices and clinics and by the patients. The new form of care not only supports the telemedical networking of doctors but also increases the compliance by involving the patient in the entire course of the illness.
- Conditions
- Glaucoma, Intraocular Pressure, Patient Empowerment, Telemedicine
- Being tested
- Self-tonometry by means of ICareHOME, Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry, Blood pressure
- Medical subject headings
- Glaucoma, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-tonometry by means of ICareHOMEProcedure or surgery
Outpatient measurement of intraocular pressure at home
Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometryProcedure or surgery
Stationary measurement of intraocular pressure in a clinic
Blood pressureProcedure or surgery
Blood pressure measurement for 24 h
| Study group | Role | What they receive |
|---|---|---|
| Outpatient measurement of intraocular pressure | Experimental | The intervention group measures its intraocular pressure itself in their home environment for 7 days at 6 a.m., 8 a.m., 12 a.m., 4 p.m., 8 p.m. and 12 p.m. with a self-tonometer (iCareHOME). Receives: Procedure: Self-tonometry by means of ICareHOME; Procedure: Blood pressure |
| Stationary measurements of intraocular pressure | Active comparator | The intraocular pressure of the control group is measured by means of rebound tonometry or Goldmann applanation tonometry in a clinic for minimum 24 hours at 6 a.m., 8 a.m., 12 a.m., 4 p.m., 8 p.m. and 12 p.m. Receives: Procedure: Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry; Procedure: Blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of observed pressure peaks (>30% of the patient-specific target pressure)
Measurement of intraocular pressure by means of ICareHOME, rebound tonometry or Goldmann applanation tonometry.
Measured: 7 days (outpatient) or minimum 24 hours (stationary)
Secondary outcomes (12)
Quality of life (patient-oriented)
By means of a questionnaire, 0: very bad state of health, 1: best possible state of health
Measured: Baseline and after 12 months
Visual field index (VFI)
By means of perimetry
Measured: Baseline and after 9 and 12 months
Mean deviation (MD)
By means of perimetry
Measured: Baseline and after 9 and 12 months
Pattern standard deviation (PSD)
By means of perimetry
Measured: Baseline and after 9 and 12 months
Retinal nerve fiber layer thickness
By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Measured: Baseline and after 12 months
Rim volume
By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Measured: Baseline and after 12 months
Rim area
By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Measured: Baseline and after 12 months
Systolic and diastolic blood pressure
Long-term blood pressure measurement
Measured: for 24 hours during outpatient and stationary measurements of intraocular pressure
Number of inpatient and outpatient health services
Care provider/ statutory health insurance (SHI) routine data
Measured: 12 month course
Costs of health services
Care provider/ SHI routine data
Measured: 12 month course
Number of periods of incapacity for work (unspecific and diagnosis-specific)
Interview/ SHI routine data
Measured: 12 month course
Number of sick pay days
Interview/ SHI routine data
Measured: 12 month course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start11 Feb 2021
- Primary completion31 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Joint Committee, Bielefeld University, Fraunhofer Institute for Applied Information Technology FIT, KVWL, BARMER, DAK Gesundheit, IKK, AOK PLUS
- Responsible party
- Principal investigator, Nicole Eter, University Hospital Muenster
- Investigators
- Nicole Eter, Prof. Dr., Principal investigator, Chairholder and Head of the Department of Ophthalmology at the University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698876
- Sponsor's protocol ID
- 01NVF18002
- Acronym
- SALUS
- Status last verified
- Jan 2024
- First submitted
- 25 Nov 2020
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oldiges K, Steinmann M, Duevel JA, Gruhn S, Diener R, Leclaire MD, Al-Nawaiseh S, Eter N; SALUS study group. SALUS-a non-inferiority trial to compare self-tonometry in glaucoma patients with regular inpatient intraocular pressure controls: study design and set-up. Graefes Arch Clin Exp Ophthalmol. 2022 Dec;260(12):3945-3955. doi: 10.1007/s00417-022-05759-7. Epub 2022 Jul 22.
PubMed 35867146
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation
- ClinicalTrials.gov ID
- NCT04698876
- Acronym / sponsor ID
- SALUS / 01NVF18002
- Conditions
- Glaucoma, Intraocular Pressure, Patient Empowerment, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Federal Joint Committee, Bielefeld University, Fraunhofer Institute for Applied Information Technology FIT, KVWL, BARMER, DAK Gesundheit, IKK, AOK PLUS
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 7 Jan 2021 (actual)
- 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.
The SALUS project is developing a new form of care, the application of self-tonometry by the patient itself, and an accompanying electronic case file connecting clinics, doctor's offices and patients.
Detailed description
The SALUS project is developing an outpatient, intersectoral form of care in which patients measure their intraocular pressure in their home environment with a so-called self-tonometer. The measured intraocular pressure values are incorporated into daily pressure profiles, which can be viewed via an electronic case file together with further examination data both by the treating ophthalmologists in the doctor's offices and clinics and by the patients. The new form of care not only supports the telemedical networking of doctors but also increases the compliance by involving the patient in the entire course of the illness.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient measurement of intraocular pressure | Experimental | Procedure: Self-tonometry by means of ICareHOME, Procedure: Blood pressureThe intervention group measures its intraocular pressure itself in their home environment for 7 days at 6 a.m., 8 a.m., 12 a.m., 4 p.m., 8 p.m. and 12 p.m. with a self-tonometer (iCareHOME). |
| Stationary measurements of intraocular pressure | Active comparator | Procedure: Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry, Procedure: Blood pressureThe intraocular pressure of the control group is measured by means of rebound tonometry or Goldmann applanation tonometry in a clinic for minimum 24 hours at 6 a.m., 8 a.m., 12 a.m., 4 p.m., 8 p.m. and 12 p.m. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Requirement of a stationary day and night measurement
- Statutory health insurance
- Verified and suspicion of glaucoma diagnosis with suspicion of pressure variations and peaks or not attained target pressure or suspicion of glaucoma progression (H40.1, H40.2 und H42.-)
- Willingness for therapy in one of the participating clinics
- Adequate German language skills
Key exclusion criteria (4 listed)
- Patients outside the catchment area of the participating clinics
- Covering illnesses in psychiatry, neurology or other indications (e.g. impairment of independence) which make self-tonometry impossible
- Strong communication barriers that do not allow the instruction to carry out the intervention
- Unclear legal capacity of the potential study participants
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 |
|---|---|---|
| Self-tonometry by means of ICareHOMEOutpatient measurement of intraocular pressure at home | Procedure or surgery | Outpatient measurement of intraocular pressure |
| Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometryStationary measurement of intraocular pressure in a clinic | Procedure or surgery | Stationary measurements of intraocular pressure |
| Blood pressureBlood pressure measurement for 24 h | Procedure or surgery | Outpatient measurement of intraocular pressure, Stationary measurements of intraocular pressure |
Primary outcome
Number of observed pressure peaks (>30% of the patient-specific target pressure)
Time frame: 7 days (outpatient) or minimum 24 hours (stationary)
Measurement of intraocular pressure by means of ICareHOME, rebound tonometry or Goldmann applanation tonometry.
12 secondary outcomes
Quality of life (patient-oriented)
Time frame: Baseline and after 12 months
Visual field index (VFI)
Time frame: Baseline and after 9 and 12 months
Mean deviation (MD)
Time frame: Baseline and after 9 and 12 months
Pattern standard deviation (PSD)
Time frame: Baseline and after 9 and 12 months
Retinal nerve fiber layer thickness
Time frame: Baseline and after 12 months
Rim volume
Time frame: Baseline and after 12 months
Rim area
Time frame: Baseline and after 12 months
Systolic and diastolic blood pressure
Time frame: for 24 hours during outpatient and stationary measurements of intraocular pressure
Number of inpatient and outpatient health services
Time frame: 12 month course
Costs of health services
Time frame: 12 month course
Number of periods of incapacity for work (unspecific and diagnosis-specific)
Time frame: 12 month course
Number of sick pay days
Time frame: 12 month course
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 26 Jan 2024.
- Derived from this study: PubMed 35867146Oldiges K, Steinmann M, Duevel JA, Gruhn S, Diener R, Leclaire MD, Al-Nawaiseh S, Eter N; SALUS study group. SALUS-a non-inferiority trial to compare self-tonometry in glaucoma patients with regular inpatient intraocular pressure controls: study design and set-up. Graefes Arch Clin Exp Ophthalmol. 2022 Dec;260(12):3945-3955. doi: 10.1007/s00417-022-05759-7. Epub 2022 Jul 22.
- SALUS HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nicole Eter, Prof. Dr. principal investigator
Chairholder and Head of the Department of Ophthalmology at the University Hospital Muenster
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-tonometry by means of ICareHOME, Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry and Blood pressure in people with Glaucoma and Intraocular Pressure, run by University Hospital Muenster at 5 sites in Germany.
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 7 inclusion and 4 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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
Number of observed pressure peaks (>30% of the patient-specific target pressure) (time frame: 7 days (outpatient) or minimum 24 hours (stationary)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04698876, which also lists 1 linked publication.
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 26 Jan 2024.