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

Study Overview
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Brief Summary
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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
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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.

Official Title
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SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation

Conditions
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Glaucoma, Intraocular Pressure, Patient Empowerment, Telemedicine

Intervention / Treatment
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* Procedure: Self-tonometry by means of ICareHOME
* Procedure: Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry
* Procedure: Blood pressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient measurement of intraocular pressure<br>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<br>* Outpatient measurement of intraocular pressure at home<br>Procedure: Blood pressure<br>* Blood pressure measurement for 24 h<br>|
| Active Comparator: Stationary measurements of intraocular pressure<br>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: Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry<br>* Stationary measurement of intraocular pressure in a clinic<br>Procedure: Blood pressure<br>* Blood pressure measurement for 24 h<br>|

What is the study measuring?
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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 |