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| Name | Class |
|---|---|
| Federal Joint Committee | OTHER_GOV |
| Bielefeld University | OTHER |
| Fraunhofer Institute for Applied Information Technology FIT | UNKNOWN |
| KVWL |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-tonometry by means of ICareHOME | Procedure | Outpatient measurement of intraocular pressure at home |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days (outpatient) or minimum 24 hours (stationary) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (patient-oriented) | By means of a questionnaire, 0: very bad state of health, 1: best possible state of health | Baseline and after 12 months |
| Visual field index (VFI) | By means of perimetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Eter, Prof. Dr. | Chairholder and Head of the Department of Ophthalmology at the University Hospital Muenster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Dortmund | Dortmund | Germany | ||||
| St.-Johannes-Hospital Dortmund |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35867146 | Derived | 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. |
| Label | URL |
|---|---|
| SALUS Homepage | View source |
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| UNKNOWN |
| BARMER | OTHER |
| DAK Gesundheit | OTHER |
| IKK | UNKNOWN |
| AOK PLUS | INDUSTRY |
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| Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry | Procedure | Stationary measurement of intraocular pressure in a clinic |
|
| Blood pressure | Procedure | Blood pressure measurement for 24 h |
|
| Baseline and after 9 and 12 months |
| Mean deviation (MD) | By means of perimetry | Baseline and after 9 and 12 months |
| Pattern standard deviation (PSD) | By means of perimetry | Baseline and after 9 and 12 months |
| Retinal nerve fiber layer thickness | By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT) | Baseline and after 12 months |
| Rim volume | By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT) | Baseline and after 12 months |
| Rim area | By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT) | Baseline and after 12 months |
| Systolic and diastolic blood pressure | Long-term blood pressure measurement | 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 | 12 month course |
| Costs of health services | Care provider/ SHI routine data | 12 month course |
| Number of periods of incapacity for work (unspecific and diagnosis-specific) | Interview/ SHI routine data | 12 month course |
| Number of sick pay days | Interview/ SHI routine data | 12 month course |
| Dortmund |
| Germany |
| Kath. Krankenhaus Hagen, St.-Josefs-Hospital | Hagen | Germany |
| Klinikum Luedenscheid | Lüdenscheid | Germany |
| University Hospital Muenster | Münster | Germany |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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