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Graefe's Archive for Clinical and Experimental Ophthalmology

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Open Access 22-07-2022 | Glaucoma | Glaucoma

SALUS—a non-inferiority trial to compare self-tonometry in glaucoma patients with regular inpatient intraocular pressure controls: study design and set-up

Authors: Kristina Oldiges, Maren Steinmann, Juliane Andrea Duevel, Sebastian Gruhn, Raphael Diener, Martin Dominik Leclaire, Sami Al-Nawaiseh, Nicole Eter, on behalf of the SALUS study group

Published in: Graefe's Archive for Clinical and Experimental Ophthalmology | Issue 12/2022

Abstract

Purpose

The SALUS study aims to improve the healthcare situation for glaucoma patients in Germany. In order to detect diurnal intraocular pressure (IOP) fluctuations, inpatient monitoring of IOP in an eye hospital for a minimum of 24 h is the current standard. SALUS assesses the benefits of a new form of outpatient care, where IOP can be measured by the patients themselves at home using a self-tonometer. This approach should promote the patient’s health competence and empowerment within the healthcare system while reducing treatment costs.

Methods

The SALUS study is a randomized controlled, open non-inferiority trial, alongside an economic analysis, determining whether outpatient monitoring of IOP with self-tonometry is at least as effective as current standard care and would reduce treatment costs. Participants (n = 1980) will be recruited by local ophthalmologists in the area of Westphalia-Lippe, Germany, and randomized to receive 7-day outpatient or 24-h inpatient monitoring. Participants in both study arms will also receive 24-h blood pressure monitoring. Furthermore, patient data from both study groups will be collected in an electronic case file (ECF), accessible to practitioners, hospitals, and the study participants. The primary endpoint is the percentage of patients with IOP peaks, defined as levels 30% above the patient-specific target pressure. Data will also be collected during initial and final examinations, and at 3, 6, and 9 months after the initial examination.

Results

The study implementation and trial management are represented below.

Conclusion

SALUS is a pioneering prospective clinical trial focused on the care of glaucoma patients in Germany. If SALUS is successful, it could improve the healthcare situation and health literacy of the patients through the introduction of various telemedical components. Furthermore, the approach would almost certainly reduce the treatment costs of glaucoma care.

Trial registration

ClinicalTrials.gov ID: NCT04698876, registration date: 11/25/2020.

DRKS-ID: DRKS00023676, registration date: 11/26/2020.

Available only for authorised users

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Title: SALUS—a non-inferiority trial to compare self-tonometry in glaucoma patients with regular inpatient intraocular pressure controls: study design and set-up
Authors: Kristina Oldiges
Maren Steinmann
Juliane Andrea Duevel
Sebastian Gruhn
Raphael Diener
Martin Dominik Leclaire
Sami Al-Nawaiseh
Nicole Eter
on behalf of the SALUS study group
Publication date: 22-07-2022
Publisher: Springer Berlin Heidelberg
Keywords: Glaucoma
Measurement of Intraocular Pressure
Published in: Graefe's Archive for Clinical and Experimental Ophthalmology / Issue 12/2022
Print ISSN: 0721-832X
Electronic ISSN: 1435-702X
DOI: https://doi.org/10.1007/s00417-022-05759-7

2024 ASCO Annual Meeting

Springer Medicine

SALUS—a non-inferiority trial to compare self-tonometry in glaucoma patients with regular inpatient intraocular pressure controls: study design and set-up

Abstract

Purpose

Methods

Results

Conclusion

Trial registration

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Trial registration

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