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

Not Applicable

Completed

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

• Registration Number: NCT04698876
• Lead Sponsor: University Hospital Muenster

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.

Study Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-07
• Study Start: 2021-02-11
• Primary Completion: 2023-10-31
• Study Completion: 2023-11-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stationary measurements of intraocular pressure	Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry	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.
Stationary measurements of intraocular pressure	Blood 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.
Outpatient measurement of intraocular pressure	Self-tonometry by means of ICareHOME	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).
Outpatient measurement of intraocular pressure	Blood 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).

Primary Outcome Measures

Name	Time	Method
Number of observed pressure peaks (>30% of the patient-specific target pressure)	7 days (outpatient) or minimum 24 hours (stationary)	Measurement of intraocular pressure by means of ICareHOME, rebound tonometry or Goldmann applanation tonometry.

Secondary Outcome Measures

Name	Time	Method
Visual field index (VFI)	Baseline and after 9 and 12 months	By means of perimetry
Quality of life (patient-oriented)	Baseline and after 12 months	By means of a questionnaire, 0: very bad state of health, 1: best possible state of health
Number of sick pay days	12 month course	Interview/ SHI routine data
Rim area	Baseline and after 12 months	By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Pattern standard deviation (PSD)	Baseline and after 9 and 12 months	By means of perimetry
Rim volume	Baseline and after 12 months	By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Mean deviation (MD)	Baseline and after 9 and 12 months	By means of perimetry
Retinal nerve fiber layer thickness	Baseline and after 12 months	By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)
Number of inpatient and outpatient health services	12 month course	Care provider/ statutory health insurance (SHI) routine data
Costs of health services	12 month course	Care provider/ SHI routine data
Number of periods of incapacity for work (unspecific and diagnosis-specific)	12 month course	Interview/ SHI routine data
Systolic and diastolic blood pressure	for 24 hours during outpatient and stationary measurements of intraocular pressure	Long-term blood pressure measurement

Trial Locations

Locations (5)

St.-Johannes-Hospital Dortmund; 🇩🇪 Dortmund, Germany

Klinikum Dortmund; 🇩🇪 Dortmund, Germany

Kath. Krankenhaus Hagen, St.-Josefs-Hospital; 🇩🇪 Hagen, Germany

Klinikum Luedenscheid; 🇩🇪 Lüdenscheid, Germany

University Hospital Muenster; 🇩🇪 Münster, Germany