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Completed

NCT Number: NCT04698876

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Dortmund, Dortmund, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-tonometry by means of ICareHOME

Procedure

Outpatient measurement of intraocular pressure at home

Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry

Procedure

Stationary measurement of intraocular pressure in a clinic

Blood pressure

Procedure

Blood pressure measurement for 24 h

Primary outcomes

  1. 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

  1. Quality of life (patient-oriented)

    Time frame: Baseline and after 12 months

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

  2. Visual field index (VFI)

    Time frame: Baseline and after 9 and 12 months

    By means of perimetry

  3. Mean deviation (MD)

    Time frame: Baseline and after 9 and 12 months

    By means of perimetry

  4. Pattern standard deviation (PSD)

    Time frame: Baseline and after 9 and 12 months

    By means of perimetry

  5. Retinal nerve fiber layer thickness

    Time frame: Baseline and after 12 months

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

  6. Rim volume

    Time frame: Baseline and after 12 months

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

  7. Rim area

    Time frame: Baseline and after 12 months

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

  8. Systolic and diastolic blood pressure

    Time frame: for 24 hours during outpatient and stationary measurements of intraocular pressure

    Long-term blood pressure measurement

  9. Number of inpatient and outpatient health services

    Time frame: 12 month course

    Care provider/ statutory health insurance (SHI) routine data

  10. Costs of health services

    Time frame: 12 month course

    Care provider/ SHI routine data

  11. Number of periods of incapacity for work (unspecific and diagnosis-specific)

    Time frame: 12 month course

    Interview/ SHI routine data

  12. Number of sick pay days

    Time frame: 12 month course

    Interview/ SHI routine data

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • AOK PLUS
  • BARMER
  • Bielefeld University
  • DAK Gesundheit
  • Federal Joint Committee
  • Fraunhofer Institute for Applied Information Technology FIT
  • IKK
  • KVWL

Registry information

Official study title

SALUS - Selbsttonometrie Und Datentransfer Bei Glaukompatienten Zur Verbesserung Der Versorgungssituation

Acronym: SALUS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 7, 2021
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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