AzTrials
AzTrials

Intravitreal InjectionsEyeMaticsNCT06810011

Eye Diseases "Treated" With Interoperable Medical Informatics

An observational study of Intravitreal Injections, run by University Hospital Muenster at 6 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intravitreal Injections
How many people
2,000 participants
Where
6 sitesGermany
Study dates
1 Mar 2024to 29 Feb 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicole Eter, Prof. Dr. contact

00492518356004

eter@uni-muenster.de

6 sites in 1 country

Germany6 sites, 6 recruiting

  • Universitätsklinikum Aachen, AöR

    Aachen, 52074

    Peter Walter, Univ.-Prof. Dr., 0049241 8088191, PWalter@ukaachen.de

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, Saxony, 09116

    Vinodh Kakkassery, Prof. Dr., 0049371 33337050, v.kakkassery@skc.de

    Recruiting

  • Universitätsmedizin Greifswald

    Greifswald, 17475

    Andreas Stahl, Univ.-Prof. Dr., 00493834 86-5900, Andreas.Stahl@med.uni-greifswald.de

    Recruiting

  • Universität Leipzig

    Leipzig, 04109

    Focke Ziemssen, Univ.-Prof. Dr., 0049 341 97 21650, focke.ziemssen@medizin.uni-leipzig.de

    Recruiting

  • Universität Münster

    Münster, 48149

    Nicole Eter, Univ.-Prof. Dr., 0049 251 83 56004, eter@uni-muenster.de

    Recruiting

  • Universitätsklinikum Tübingen

    Tübingen, 72076

    Karl Ulrich Bartz-Schmidt, Univ.-Prof. Dr., 00497071 2925092, Karl-Ulrich.Bartz-Schmidt@med.uni-tuebingen.de

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Keywords
Artificial intelligence, Core dataset, Intraviteal Injection, Medical Informatics, Data exchange

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medical success

    changes in visual acuity during the course of treatment

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

Secondary outcomes (5)

  1. Treatment latency period:

    latency period within the treatment and monitoring cycle as days between the indication/OCT examination and the implementation of IVOM treatment

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

  2. Treatment and monitoring frequency

    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.

    Measured: during the procedure

  3. Treatment adherence

    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.

    Measured: during the procedure

  4. Treatment persistence

    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.

    Measured: during the procedure

  5. Patient-relevant outcomes (PROMs)

    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

    Measured: every 6 months within 12, 24 and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start1 Mar 2024
  3. Primary completion29 Feb 2028 (estimated)
  4. Study completion29 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06810011
Sponsor's protocol ID
01ZZ2319A-I
Other IDs
01ZZ2319A-I
Acronym
EyeMatics
Status last verified
Jan 2025
First submitted
12 Dec 2024
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39542916

Questions about this trial

What is this clinical trial studying?

An observational study of Intravitreal Injections, run by University Hospital Muenster at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicole Eter, Prof. Dr. (00492518356004, eter@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medical success (time frame: with every treatment or controll-visit within 12, 24 and 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06810011, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in