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

Primary Purpose

Glaucoma, Intraocular Pressure, Patient Empowerment

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Self-tonometry by means of ICareHOME
Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry
Blood pressure
Sponsored by
University Hospital Muenster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Outpatient measurement of intraocular pressure

Stationary measurements of intraocular pressure

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of life (patient-oriented)
By means of a questionnaire, 0: very bad state of health, 1: best possible state of health
Visual field index (VFI)
By means of perimetry
Mean deviation (MD)
By means of perimetry
Pattern standard deviation (PSD)
By means of perimetry
Retinal nerve fiber layer thickness
By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Rim volume
By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Rim area
By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Systolic and diastolic blood pressure
Long-term blood pressure measurement
Number of inpatient and outpatient health services
Care provider/ statutory health insurance (SHI) routine data
Costs of health services
Care provider/ SHI routine data
Number of periods of incapacity for work (unspecific and diagnosis-specific)
Interview/ SHI routine data
Number of sick pay days
Interview/ SHI routine data

Full Information

First Posted
November 25, 2020
Last Updated
July 7, 2022
Sponsor
University Hospital Muenster
Collaborators
Federal Joint Committee, Bielefeld University, Fraunhofer Institute for Applied Information Technology FIT, KVWL, BARMER, DAK Gesundheit, IKK, AOK PLUS
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1. Study Identification

Unique Protocol Identification Number
NCT04698876
Brief Title
Self Tonometry and Transfer of Glaucoma Patients' Data for Improving the Supply Situation
Acronym
SALUS
Official Title
SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Muenster
Collaborators
Federal Joint Committee, Bielefeld University, Fraunhofer Institute for Applied Information Technology FIT, KVWL, BARMER, DAK Gesundheit, IKK, AOK PLUS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Intraocular Pressure, Patient Empowerment, Telemedicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient measurement of intraocular pressure
Arm Type
Experimental
Arm Description
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).
Arm Title
Stationary measurements of intraocular pressure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Self-tonometry by means of ICareHOME
Intervention Description
Outpatient measurement of intraocular pressure at home
Intervention Type
Procedure
Intervention Name(s)
Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry
Intervention Description
Stationary measurement of intraocular pressure in a clinic
Intervention Type
Procedure
Intervention Name(s)
Blood pressure
Intervention Description
Blood pressure measurement for 24 h
Primary Outcome Measure Information:
Title
Number of observed pressure peaks (>30% of the patient-specific target pressure)
Description
Measurement of intraocular pressure by means of ICareHOME, rebound tonometry or Goldmann applanation tonometry.
Time Frame
7 days (outpatient) or minimum 24 hours (stationary)
Secondary Outcome Measure Information:
Title
Quality of life (patient-oriented)
Description
By means of a questionnaire, 0: very bad state of health, 1: best possible state of health
Time Frame
Baseline and after 12 months
Title
Visual field index (VFI)
Description
By means of perimetry
Time Frame
Baseline and after 9 and 12 months
Title
Mean deviation (MD)
Description
By means of perimetry
Time Frame
Baseline and after 9 and 12 months
Title
Pattern standard deviation (PSD)
Description
By means of perimetry
Time Frame
Baseline and after 9 and 12 months
Title
Retinal nerve fiber layer thickness
Description
By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Time Frame
Baseline and after 12 months
Title
Rim volume
Description
By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Time Frame
Baseline and after 12 months
Title
Rim area
Description
By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Time Frame
Baseline and after 12 months
Title
Systolic and diastolic blood pressure
Description
Long-term blood pressure measurement
Time Frame
for 24 hours during outpatient and stationary measurements of intraocular pressure
Title
Number of inpatient and outpatient health services
Description
Care provider/ statutory health insurance (SHI) routine data
Time Frame
12 month course
Title
Costs of health services
Description
Care provider/ SHI routine data
Time Frame
12 month course
Title
Number of periods of incapacity for work (unspecific and diagnosis-specific)
Description
Interview/ SHI routine data
Time Frame
12 month course
Title
Number of sick pay days
Description
Interview/ SHI routine data
Time Frame
12 month course

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Eter, Prof. Dr.
Organizational Affiliation
Chairholder and Head of the Department of Ophthalmology at the University Hospital Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Dortmund
City
Dortmund
Country
Germany
Facility Name
St.-Johannes-Hospital Dortmund
City
Dortmund
Country
Germany
Facility Name
Kath. Krankenhaus Hagen, St.-Josefs-Hospital
City
Hagen
Country
Germany
Facility Name
Klinikum Luedenscheid
City
Lüdenscheid
Country
Germany
Facility Name
University Hospital Muenster
City
Münster
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35867146
Citation
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.
Results Reference
derived

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

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