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

University Hospital Muenster267 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

267

Conditions

Glaucoma Intraocular Pressure Patient Empowerment Telemedicine

Interventions

Self-tonometry by means of ICareHOMEPROCEDURE

Outpatient measurement of intraocular pressure at home

Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometryPROCEDURE

Stationary measurement of intraocular pressure in a clinic

Blood pressurePROCEDURE

Blood pressure measurement for 24 h

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

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.

Time frame: 7 days (outpatient) or minimum 24 hours (stationary)

Secondary Outcomes

Quality of life (patient-oriented)

By means of a questionnaire, 0: very bad state of health, 1: best possible state of health

Time frame: Baseline and after 12 months

Visual field index (VFI)

By means of perimetry

Time frame: Baseline and after 9 and 12 months

Mean deviation (MD)

By means of perimetry

Time frame: Baseline and after 9 and 12 months

Pattern standard deviation (PSD)

By means of perimetry

Time frame: Baseline and after 9 and 12 months

Retinal nerve fiber layer thickness

By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)

Time frame: Baseline and after 12 months

Rim volume

By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)

Time frame: Baseline and after 12 months

Rim area

By means of Optical Coherence Tomography (OCT)/ Heidelberg Retina Tomography (HRT)

Data from ClinicalTrials.gov

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