KeratoconusNCT03184610
Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution OCT
An observational study of Keratoconus, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The OCT used in this trial offers the advantage of both a non-contact method and a very high axial resolution. Determined parameters with the highest potential of diagnostic discrimination between eyes with Keratoconus and healthy eyes are investigated. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- OCT-scanning
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2014to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eyes with Keratoconus Healthy eyes
Who may be able to join
- Age>18
- Existence of Keratoconus
- written informed consent obtained
Who cannot join
- Earlier surgery such as PK, CXL, relaxing incisions
- Systemic diseases
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Ophthalmology
Vienna, 1090
About this study
Official title: Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution Optical Coherence Tomography (UHR-OCT) Based Corneal Epithelium Thickness Mapping
The OCT used in this trial offers the advantage of both a non-contact method and a very high axial resolution. Determined parameters with the highest potential of diagnostic discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this trial is to investigate differences of specific parameters of epithelium thickness maps at healthy eyes and eyes with Keratoconus.
- Conditions
- Keratoconus
- Being tested
- OCT-scanning
- Keywords
- Keratoconus, Optical Coherence Tomography, Corneal Epithelium Thickness Maps
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-scanningDevice
All participants will be scanned with a OCT-device
| Study group | Role | What they receive |
|---|---|---|
| OCT-scanning | Patients with Keratoconus are scanned with an OCT-Prototype Receives: Device: OCT-scanning | |
| OCT-scanning for volunteers | Volunteers with healthy eyes are scanned with an OCT-Prototype Receives: Device: OCT-scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Epithelium Thickness
Parameters collected from epithelium thickness data and maps
Measured: One visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study startDec 2014
- Primary completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald Schmidinger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184610
- Sponsor's protocol ID
- 1160/2014
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution Optical Coherence Tomography (UHR-OCT) Based Corneal Epithelium Thickness Mapping
- ClinicalTrials.gov ID
- NCT03184610
- Acronym / sponsor ID
- 1160/2014
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Optical Coherence Tomography, Corneal Epithelium Thickness Maps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- First posted
- 12 Jun 2017 (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.
The OCT used in this trial offers the advantage of both a non-contact method and a very high axial resolution. Determined parameters with the highest potential of diagnostic discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this trial is to investigate differences of specific parameters of epithelium thickness maps at healthy eyes and eyes with Keratoconus.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT-scanning | – | Device: OCT-scanningPatients with Keratoconus are scanned with an OCT-Prototype |
| OCT-scanning for volunteers | – | Device: OCT-scanningVolunteers with healthy eyes are scanned with an OCT-Prototype |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eyes with Keratoconus Healthy eyes
Key inclusion criteria (3 listed)
- Age>18
- Existence of Keratoconus
- written informed consent obtained
Key exclusion criteria (2 listed)
- Earlier surgery such as PK, CXL, relaxing incisions
- Systemic diseases
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 |
|---|---|---|
| OCT-scanningAll participants will be scanned with a OCT-device | Device | OCT-scanning, OCT-scanning for volunteers |
Primary outcome
Corneal Epithelium Thickness
Time frame: One visit
Parameters collected from epithelium thickness data and maps
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Keratoconus, run by Medical University of Vienna 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 2 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: finished, as of the sponsor's last update on 12 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Epithelium Thickness (time frame: One visit). 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 12 Jun 2017.