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NCT Number: NCT06810011

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.

Recruiting

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Key information

Conditions

Intravitreal Injections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Chemnitz gGmbH, Chemnitz, Saxony, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Eter, Prof. Dr.

CONTACT

[email protected]

00492518356004

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

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

Registry information

Official study title

EyeMatics - Eye Diseases "Treated" With Interoperable Medical Informatics

Acronym: EyeMatics

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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