Intravitreal Injections
Conditions
Keywords
Artificial intelligence, Core dataset, Intraviteal Injection, Medical Informatics, Data exchange
Brief summary
The overarching goal of EyeMatics is to promote an interoperable, sustainable infrastructure for the integration and sharing of data from clinical research to improve personalized medicine in ophthalmology. To achieve this, EyeMatics bundles the expertise and preliminary work of the four consortia of the Medical Informatics Initiative (MII) and the ophthalmological centers of excellence in Germany. The perspective and concerns of patients will be strongly incorporated into the project work through close cooperation with patient representatives and the inclusion of patient feedback on quality of life and treatment success. EyeMatics aims to improve the understanding of the therapeutic success of eye diseases that are usually treated with intravitreal surgical medication (IVOM). To this end, an exemplary analysis platform for real clinical data will be provided and a dashboard for data visualization and analysis will be developed as a web application. The dashboard is to be introduced at all participating hospital sites for research purposes.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* OPS code: 5-156.9 Injection of drugs into the posterior segment of the eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical success | with every treatment or controll-visit within 12, 24 and 36 months | changes in visual acuity during the course of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment latency period: | from indication to treatment begin (Depending on the treatment regimen, assessed up to 6 months) | latency period within the treatment and monitoring cycle as days between the indication/OCT examination and the implementation of IVOM treatment |
| Treatment and monitoring frequency | during the procedure | Considered for the injection upload phase and for the first 12, 24 and 36 months of treatment. The number of injections is evaluated at patient level as a quality indicator and for the various treatment regimens, indications and clinical centers. |
| Treatment adherence | during the procedure | Non-adherence to treatment is defined as those patients who did not receive any control or therapy without a planned treatment/control gap of 3 months. |
| Treatment persistence | during the procedure | Treatment non-persistence is defined as the number of patients who received no further monitoring or treatment for a period of at least 6 months and did not resume treatment at the time of analysis. |
| Patient-relevant outcomes (PROMs) | every 6 months within 12, 24 and 36 months | intravitreal injection specific PROM-questionnaire, including aspects of visual quality of life, socio-emotional quality of life, therapy and therapy environment, process quality, internal quality management, knowledge of the disease and pain |
Countries
Germany