Retinal DiseaseNCT06074731
Diagnostic Possibilities in Ophthalmological Diseases Using Swept Source Optical Coherence Tomography
An observational study of Retinal Disease and Diabetic Retinopathy, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease, Diabetic Retinopathy, Macular Degeneration
- What is being tested?
- SS-OCT system Plex Elite 9000
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2017to Dec 2026
- 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 5 to 110 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Age between 5 and 110 years
- Ability to follow instructions during imaging procedure
- Written Informed consent
Who cannot join
- Dementia
- Inability to follow instructions during imaging procedure
- Patients who do not give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria
Linz, Upper Austria, 4020
Matthias Bolz, Prof.Dr.
About this study
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
- Being tested
- SS-OCT system Plex Elite 9000
- Medical subject headings
- Retinal Diseases, Diabetic Retinopathy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SS-OCT system Plex Elite 9000Diagnostic test
We will use a commercially available SS-OCT system (Plex Elite 9000; Carl Zeiss Meditec).
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphological changes using Swept Source Optical Coherence Tomography
Morphological changes in retinal diseases provided by Swept Source Optical
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jun 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Bolz, Johannes Kepler University of Linz
- Investigators
- Matthias Bolz, Prof. Dr., Principal investigator, Department for Ophthalmology, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074731
- Sponsor's protocol ID
- KUK-Ophthalmology-001
- Status last verified
- Oct 2023
- First submitted
- 15 Jan 2019
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Possibilities in Ophthalmological Diseases Using Swept Source Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT06074731
- Acronym / sponsor ID
- KUK-Ophthalmology-001
- Conditions
- Retinal Disease, Diabetic Retinopathy, Macular Degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age between 5 and 110 years
- Ability to follow instructions during imaging procedure
- Written Informed consent
Key exclusion criteria (3 listed)
- Dementia
- Inability to follow instructions during imaging procedure
- Patients who do not give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SS-OCT system Plex Elite 9000We will use a commercially available SS-OCT system (Plex Elite 9000; Carl Zeiss Meditec). | Diagnostic test | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Bolz, Prof. Dr. principal investigator
Department for Ophthalmology, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease and Diabetic Retinopathy, run by Johannes Kepler University of Linz at 1 site in Austria.
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 3 inclusion and 3 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 Matthias Bolz, Prof. Dr. (+43 (0)5 7680 83 - 1050, matthias.bolz@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphological changes using Swept Source Optical Coherence Tomography (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2023; AzTrials last refreshed its copy on 2 Nov 2026.