Clinical trial NCT06810011: Eye Diseases "Treated" with Interoperable Medical Informatics
Official title: EyeMatics - Eye Diseases "Treated" with Interoperable Medical Informatics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intravitreal Injections
Keywords: Artificial intelligence
Core dataset
Intraviteal Injection
Medical Informatics
Data exchange
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: University Medicine Greifswald
name: University Medical Center Mainz
name: University Hospital, Aachen
name: Klinikum Chemnitz gGmbH
name: Technische UniversitÃ¤t Dresden
name: University of Leipzig
name: University Hospital Tuebingen
name: Deutsche Ophthalmologische Gesellschaft e.V.
name: Pro Retina Deutschland e.V.
First posted: 2025-02-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving intravitreal injections at the study centers with signed Broad Consent (Consent of the Medical Informatics Initiative Germany).

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.


Eligibility criteria: Inclusion Criteria:

* OPS code: "5-156.9 Injection of drugs into the posterior segment of the eye"

Primary outcomes:
measure: Medical success
timeFrame: with every treatment or controll-visit within 12, 24 and 36 months
Secondary outcomes:
measure: Treatment latency period:
timeFrame: from indication to treatment begin (Depending on the treatment regimen, assessed up to 6 months)
measure: Treatment and monitoring frequency
timeFrame: during the procedure
measure: Treatment adherence
timeFrame: during the procedure
measure: Treatment persistence
timeFrame: during the procedure
measure: Patient-relevant outcomes (PROMs)
timeFrame: every 6 months within 12, 24 and 36 months
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
state: Sachsen
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, AöR
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Leipzig
country: Germany
facility: Universität Leipzig
city: Münster
country: Germany
facility: Universität Münster
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
Study officials:
References:
citation: Holtrup L, Varghese J, Schuster AK, Poschkamp B, Hampf C, Waltemath D, Wahle L, Lipprandt M, Merle DA, Berens P, Kohlbacher O, Kakkassery V, Bartos M, Ziemssen F, Wendt T, Hoffmann K; EyeMatics Study Group; Eter N. [EyeMatics-Multicenter data evaluation of real-world data with interoperable medical informatics]. Ophthalmologie. 2025 Apr;122(4):270-277. doi: 10.1007/s00347-024-02135-0. Epub 2024 Nov 14. German.