Diagnostic Possibilities in Ophthalmological Diseases Using Swept Source Optical Coherence Tomography

October 3, 2023 updated by: Matthias Bolz, Johannes Kepler University of Linz
In this pilot study we want to investigate morphological features acquired by the novel image modality and gain information regarding disease pathomechanism, development and future possible influence on disease management for patients affected by those diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

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

  • Austria
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Recruiting
        • Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria
        • Contact:
          • Matthias Bolz, Prof.Dr.

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The participants will be selected by the Department of Ophthalmology at Kepler University Clinic Linz. All patients of the department scheduled for an outgoing appointment with regular examination in the time period of the study can be included in the study. Patients are being examined in the outgoing clinics with standard examinations. Additionally an image using the Zeiss Plex Elite 9000 Swept Source OCT is being performed. Patients of interest for this pilot study are patients with retinal, choroidal, vascular or glaucomatous changes.

Description

Inclusion Criteria:

  • Age between 5 and 110 years
  • Ability to follow instructions during imaging procedure
  • Written Informed consent

Exclusion Criteria:

  • Dementia
  • Inability to follow instructions during imaging procedure
  • Patients who do not give informed consent

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
Morphological changes using Swept Source Optical Coherence Tomography
Time Frame: through study completion, an average of 1 year
Morphological changes in retinal diseases provided by Swept Source Optical
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Johannes Kepler University of Linz

Investigators

  • Principal Investigator: Matthias Bolz, Prof. Dr., Department for Ophthalmology, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria

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)

June 1, 2017

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Estimated)

October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUK-Ophthalmology-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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