Self Tonometry and Transfer of Glaucoma Patients' Data for Improving the Supply Situation (SALUS)

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Intraocular Pressure; Telemedicine; Patient Empowerment
• Intervention / Treatment: Procedure: Self-tonometry by means of ICareHOME; Procedure: Blood pressure; Procedure: Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry

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 Type: Interventional
• Enrollment (Actual): 267
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dortmund, Germany
    • Klinikum Dortmund
  • Dortmund, Germany
    • St.-Johannes-Hospital Dortmund
  • Hagen, Germany
    • Kath. Krankenhaus Hagen, St.-Josefs-Hospital
  • Lüdenscheid, Germany
    • Klinikum Luedenscheid
  • Münster, Germany
    • University hospital Muenster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient measurement of intraocular pressure; 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).	Procedure: Self-tonometry by means of ICareHOME; Outpatient measurement of intraocular pressure at home; Procedure: Blood pressure; Blood pressure measurement for 24 h
Active Comparator: Stationary measurements of intraocular pressure; 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.	Procedure: Blood pressure; Blood pressure measurement for 24 h; Procedure: Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry; Stationary measurement of intraocular pressure in a clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: BARMER; Bielefeld University; Federal Joint Committee; DAK Gesundheit; AOK PLUS; Fraunhofer Institute for Applied Information Technology FIT; KVWL; IKK
• Investigators: Principal Investigator: Nicole Eter, Prof. Dr., Chairholder and Head of the Department of Ophthalmology at the University Hospital Muenster

Publications and helpful links

General 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.

Helpful Links

• SALUS Homepage

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 01NVF18002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No