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

University Hospital Muenster

Status: Completed

Conditions: Patient Empowerment; Glaucoma; Intraocular Pressure; Telemedicine

Treatments: Procedure: Self-tonometry by means of ICareHOME; Procedure: Blood pressure; Procedure: Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04698876

01NVF18002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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267 participants in 2 patient groups

Outpatient measurement of intraocular pressure

Experimental group

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).

Treatment:

Procedure: Self-tonometry by means of ICareHOME

Procedure: Blood pressure

Stationary measurements of intraocular pressure

Active Comparator group

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.

Treatment:

Procedure: Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry

Procedure: Blood pressure