Self Tonometry and Transfer of Glaucoma Patients' Data for Improving the Supply Situation
SALUS
SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation
1 other identifier
interventional
267
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2020
CompletedFirst Posted
Study publicly available on registry
January 7, 2021
CompletedStudy Start
First participant enrolled
February 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedJanuary 26, 2024
January 1, 2024
2.7 years
November 25, 2020
January 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (12)
Quality of life (patient-oriented)
Baseline and after 12 months
Visual field index (VFI)
Baseline and after 9 and 12 months
Mean deviation (MD)
Baseline and after 9 and 12 months
Pattern standard deviation (PSD)
Baseline and after 9 and 12 months
Retinal nerve fiber layer thickness
Baseline and after 12 months
- +7 more secondary outcomes
Study Arms (2)
Outpatient measurement of intraocular pressure
EXPERIMENTALThe 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 COMPARATORThe 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.
Interventions
Outpatient measurement of intraocular pressure at home
Stationary measurement of intraocular pressure in a clinic
Blood pressure measurement for 24 h
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Muensterlead
- Federal Joint Committeecollaborator
- Bielefeld Universitycollaborator
- Fraunhofer Institute for Applied Information Technology FITcollaborator
- KVWLcollaborator
- BARMERcollaborator
- DAK Gesundheitcollaborator
- IKKcollaborator
- AOK PLUScollaborator
Study Sites (5)
Klinikum Dortmund
Dortmund, Germany
St.-Johannes-Hospital Dortmund
Dortmund, Germany
Kath. Krankenhaus Hagen, St.-Josefs-Hospital
Hagen, Germany
Klinikum Luedenscheid
Lüdenscheid, Germany
University Hospital Muenster
Münster, Germany
Related Publications (1)
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.
PMID: 35867146DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole Eter, Prof. Dr.
Chairholder and Head of the Department of Ophthalmology at the University Hospital Muenster
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairholder and Head of the Department of Ophthalmology
Study Record Dates
First Submitted
November 25, 2020
First Posted
January 7, 2021
Study Start
February 11, 2021
Primary Completion
October 31, 2023
Study Completion
November 30, 2023
Last Updated
January 26, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share