Diagnostic Possibilities in Ophthalmological Diseases Using Swept Source Optical Coherence Tomography

NCT06074731 | Recruiting

• 1 other identifier: KUK-Ophthalmology-001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinal Disease; Diabetic Retinopathy; Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Morphological changes using Swept Source Optical Coherence Tomography

  Morphological changes in retinal diseases provided by Swept Source Optical

  through study completion, an average of 1 year

Interventions

SS-OCT system Plex Elite 9000 DIAGNOSTIC_TEST

We will use a commercially available SS-OCT system (Plex Elite 9000; Carl Zeiss Meditec).

Eligibility Criteria

• Age: 5 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johannes Kepler University of Linz: lead

Study Sites (1)

Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria

Linz, Upper Austria, 4020, Austria

RECRUITING

MeSH Terms

Conditions

Retinal Diseases; Diabetic Retinopathy; Macular Degeneration

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Degeneration

Study Officials

• Matthias Bolz, Prof. Dr.

  Department for Ophthalmology, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Bolz, Prof. Dr.

CONTACT

+43 (0)5 7680 83 - 1050; matthias.bolz@kepleruniklinikum.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology and Optometry

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: October 10, 2023
• Study Start: June 1, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)