SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 267
- Locations
- 5
- Primary Endpoint
- Number of observed pressure peaks (>30% of the patient-specific target pressure)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of observed pressure peaks (>30% of the patient-specific target pressure)
Time Frame: 7 days (outpatient) or minimum 24 hours (stationary)
Measurement of intraocular pressure by means of ICareHOME, rebound tonometry or Goldmann applanation tonometry.
Secondary Outcomes
- Visual field index (VFI)(Baseline and after 9 and 12 months)
- Quality of life (patient-oriented)(Baseline and after 12 months)
- Number of sick pay days(12 month course)
- Pattern standard deviation (PSD)(Baseline and after 9 and 12 months)
- Rim volume(Baseline and after 12 months)
- Rim area(Baseline and after 12 months)
- Mean deviation (MD)(Baseline and after 9 and 12 months)
- Retinal nerve fiber layer thickness(Baseline and after 12 months)
- Number of inpatient and outpatient health services(12 month course)
- Costs of health services(12 month course)
- Number of periods of incapacity for work (unspecific and diagnosis-specific)(12 month course)
- Systolic and diastolic blood pressure(for 24 hours during outpatient and stationary measurements of intraocular pressure)
Investigators
Nicole Eter
Chairholder and Head of the Department of Ophthalmology
University Hospital Muenster