Eye Diseases "Treated" with Interoperable Medical Informatics (EyeMatics)

January 30, 2025 updated by: Nicole Eter, University Hospital Muenster

EyeMatics - Eye Diseases "Treated" with Interoperable Medical Informatics

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • Universitätsklinikum Aachen, AöR
        • Contact:
      • Greifswald, Germany, 17475
      • Leipzig, Germany, 04109
      • Münster, Germany, 48149
        • Recruiting
        • Universität Münster
        • Contact:
      • Tübingen, Germany, 72076
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09116
        • Recruiting
        • Klinikum Chemnitz gGmbH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical success
Time Frame: with every treatment or controll-visit within 12, 24 and 36 months
changes in visual acuity during the course of treatment
with every treatment or controll-visit within 12, 24 and 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment latency period:
Time Frame: 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
from indication to treatment begin (Depending on the treatment regimen, assessed up to 6 months)
Treatment and monitoring frequency
Time Frame: 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.
during the procedure
Treatment adherence
Time Frame: 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.
during the procedure
Treatment persistence
Time Frame: 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.
during the procedure
Patient-relevant outcomes (PROMs)
Time Frame: 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
every 6 months within 12, 24 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

University of Leipzig
University Medicine Greifswald
University Hospital Tuebingen
University Hospital, Aachen
University Medical Center Mainz
Klinikum Chemnitz gGmbH
Technische Universität Dresden
Deutsche Ophthalmologische Gesellschaft e.V.
Pro Retina Deutschland e.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

February 29, 2028

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01ZZ2319A-I (Other Grant/Funding Number: Federal Ministry of Education and Research)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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