NCT06810011

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Mar 2024Feb 2028

Study Start

First participant enrolled

March 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2028

Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

4 years

First QC Date

December 12, 2024

Last Update Submit

January 30, 2025

Conditions

Keywords

Artificial intelligenceCore datasetIntraviteal InjectionMedical InformaticsData exchange

Outcome Measures

Primary Outcomes (1)

  • Medical success

    changes in visual acuity during the course of treatment

    with every treatment or controll-visit within 12, 24 and 36 months

Secondary Outcomes (5)

  • Treatment latency period:

    from indication to treatment begin (Depending on the treatment regimen, assessed up to 6 months)

  • Treatment and monitoring frequency

    during the procedure

  • Treatment adherence

    during the procedure

  • Treatment persistence

    during the procedure

  • Patient-relevant outcomes (PROMs)

    every 6 months within 12, 24 and 36 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving intravitreal injections at the study centers with signed Broad Consent (Consent of the Medical Informatics Initiative Germany).

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, 09116, Germany

RECRUITING

Universitätsklinikum Aachen, AöR

Aachen, 52074, Germany

RECRUITING

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

RECRUITING

Universität Leipzig

Leipzig, 04109, Germany

RECRUITING

Universität Münster

Münster, 48149, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39542916BACKGROUND

Central Study Contacts

Nicole Eter, Prof. Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. med. Nicole Eter

Study Record Dates

First Submitted

December 12, 2024

First Posted

February 5, 2025

Study Start

March 1, 2024

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

February 29, 2028

Last Updated

February 5, 2025

Record last verified: 2025-01

Locations