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

Glaucoma Clinical Trial

— SALUS  

Official title:

SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04698876
• Other study ID #: 01NVF18002
• Status: Completed
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: November 30, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Intraocular Pressure
• Patient Empowerment
• Telemedicine

Intervention

Procedure:
• Self-tonometry by means of ICareHOME
Outpatient measurement of intraocular pressure at home
• Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry
Stationary measurement of intraocular pressure in a clinic
• Blood pressure
Blood pressure measurement for 24 h

Locations

Country	Name	City	State
Germany	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

Sponsors (9)

Lead Sponsor	Collaborator
University Hospital Muenster	AOK PLUS, BARMER, Bielefeld University, DAK Gesundheit, Federal Joint Committee, Fraunhofer Institute for Applied Information Technology FIT, IKK, KVWL

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Visual field index (VFI)	By means of perimetry	Baseline and after 9 and 12 months
Secondary	Mean deviation (MD)	By means of perimetry	Baseline and after 9 and 12 months
Secondary	Pattern standard deviation (PSD)	By means of perimetry	Baseline and after 9 and 12 months
Secondary	Retinal nerve fiber layer thickness	By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)	Baseline and after 12 months
Secondary	Rim volume	By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)	Baseline and after 12 months
Secondary	Rim area	By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)	Baseline and after 12 months
Secondary	Systolic and diastolic blood pressure	Long-term blood pressure measurement	for 24 hours during outpatient and stationary measurements of intraocular pressure
Secondary	Number of inpatient and outpatient health services	Care provider/ statutory health insurance (SHI) routine data	12 month course
Secondary	Costs of health services	Care provider/ SHI routine data	12 month course
Secondary	Number of periods of incapacity for work (unspecific and diagnosis-specific)	Interview/ SHI routine data	12 month course
Secondary	Number of sick pay days	Interview/ SHI routine data	12 month course

External Links

•   SALUS Homepage