H40.1
Conditions
Interventions
Group 1: Intervention group
Usage of Visooma Glaucoma App as an add-on to usual care (Care-as-usual - CAU) for 3 months. Participants have unrestricted access to all services within usual care.
As st
Sponsors
Santen GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects with an ICD-10 Code of H40.1 (Primary Open-Angle Glaucoma) and using IOP lowering medication in both eyes 2. Subjects not expected /considered to be at risk for glaucoma progression with their own medication during the clinical investigation as judged by the investigator 4. German language proficiency and capability of providing informed consent 5. Experienced in the use of smartphones or tablets and have a smartphone with either iOS 16 or Android 9 operating system or higher 6. No expected change in the Glaucoma medication/ procedures within the study period in one or both eyes.
Exclusion criteria
Exclusion criteria: 1. Newly diagnosed subjects with glaucoma medication started less than 6 months ago in one or both eyes 2. IOP less than 12 mmHg with glaucoma medication (to be checked at Visit 1) in one or both eyes 3. Subjects with a change in Glaucoma treatment (both pharmacological and non-pharmacological) within 6 months prior to study enrollment in one or both eyes 4. Paediatric glaucoma, angle closure glaucoma or secondary Glaucoma 5. Subjects whose treatment for glaucoma is anticipated to change during the study period (Changes in Glaucoma medication, assumed ocular surgery including e.g. laser, cataract surgery, MIGs (Microinvasive Glaucoma Surgeries) and filtration surgery) or who are anticipated to have changes in their concomitant medication that may induce changes in IOP in one or both eyes 6. Subjects with alcohol or drug problems 7. Subjects who are pregnant, nursing or planning a pregnancy 8. Epilepsy 9. Severe mental, psychological and psychiatric disorders including dementia and schizophrenia 10. Use of similar digital or non-digital (e.g., analogue) treatment or support measures (e.g., personal coaching, telephone-based programs) focusing on monitoring, behaviour change, and/or adherence support in the past 6 months, or planned use during the course of the study, which may have an impact on the study analysis. 11. Persons who use the Visooma Glaucoma App or family members, partners of the study participant or persons living in the same household with the study participant 12. Persons with either previous (within 6 months prior to enrolment) or current participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean diurnal IOP (intraocular pressure) at Month 3 in subjects with POAG (primary open angle glaucoma) and baseline IOP =18mmHg on medication Timing of IOP measurements for primary endpoints: on day 0 (baseline), day 28 (month 1), and day 90 (month 3). IOP measurements are taken at the trial center using a calibrated Goldmann applanation tonometer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint: • Mean change from baseline in Morisky Adherence Scale (MMAS-8, all subjects) at Month 3 • Change from baseline in mean diurnal IOP at Month 3 in all subjects with POAG on medication Other secondary endpoints: • Proportion of subjects with mean diurnal IOP less than 18 mmHg at Month 1 and 3 • Proportions of subjects with a mean diurnal IOP reduction of =1 mmHg or =10% in mean diurnal at Month 1 and 3 • Change in mean diurnal IOP at Month 1 in subjects with baseline IOP =18 mmHg • Change in mean diurnal IOP in subjects with baseline IOP <18 mmHg at Month 1 and Month 3 • Change in mean diurnal IOP in all subjects at Month 1 and 3 • Mean change from baseline in Morisky Adherence Scale (MMAS-8, all subjects) at Month 1 • Mean change from baseline in Morisky Adherence Scale at Month 1 and 3 by adherence subgroups (low, medium, high) and by IOP (IOP <18 or IOP =18 mmHg at baseline) • Proportion of subjects with at least one grade change from baseline in the Morisky Adherence Scale at Month 1 and Month 3 • Proportion of subjects improving the adherence category from low to medium/high or from medium to high in the MMAS-8 at Month 1 and Month 3 • Correlation between adherence and mean diurnal IOP at Month 3 Timing of IOP measurements for secondary endpoints: on day 0 (baseline), day 28 (month 1), and day 90 (month 3). IOP measurements are taken at the trial center using a calibrated Goldmann applanation tonometer. Checking medication adherence (MMAS-8 questionnaire): on day 0 (baseline), day 28 (month 1), and day 90 (month 3). Questionnaires are completed by the patient at the trial center. | — |
Countries
Germany
Contacts
Public ContactVerena Prokosch
Augenklinik, Uniklinik Köln
Outcome results
None listed