KeratoconusNCT04383366
Agreement and Accuracy of Different Devices Corneal Measurements
An observational study of Keratoconus, run by Gerald Schmidinger at 1 site in Austria.
Trial summary
To compare repeatability, reproducibility and agreement of both, AS- OCT and Scheimpflug imaging, for the measurement of corneal curvature and corneal thickness in patients with keratoconus. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Pentacam® (Oculus, Inc., Wetzlar, Germany), Casia II (Tomey Germany, Nürnberg) and Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 21 Oct 2019to 6 Feb 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 50 patients with keratoconus will be recruited in the outpatient department of the Department of Ophthalmology.
Who may be able to join
- Men and women aged between 18 and 99 years
- Presence of keratoconus
- Signed informed consent
Who cannot join
- Contact lens history within 5 days
- Pathologic changes of the lid or conjunctiva on slit-lamp examination
- History of corneal ocular surgery/Previous corneal cross-linking
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: Agreement and Accuracy of Different Devices for the Measurement of Corneal Thickness and Corneal Curvature in Patients With Keratoconus
To compare repeatability, reproducibility and agreement of both, AS- OCT and Scheimpflug imaging, for the measurement of corneal curvature and corneal thickness in patients with keratoconus.
- Conditions
- Keratoconus
- Being tested
- Pentacam® (Oculus, Inc., Wetzlar, Germany), Casia II (Tomey Germany, Nürnberg), Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentacam® (Oculus, Inc., Wetzlar, Germany)Device
Scheimpflug imaging
Casia II (Tomey Germany, Nürnberg)Device
Anterior segment optical coherence tomography
Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)Device
Anterior segment optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| Patients with keratoconus | Not described Receives: Device: Pentacam® (Oculus, Inc., Wetzlar, Germany); Device: Casia II (Tomey Germany, Nürnberg); Device: Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum K-value
Measured: 1 day
Secondary outcomes (4)
Simulated minimum and maximum K-value
Measured: 1 day
Mean K-values
Measured: 1 day
Central Corneal thickness
Measured: 1 day
Thinnest corneal point
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start21 Oct 2019
- Primary completion6 Feb 2020
- Study completion6 Feb 2020
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.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerald Schmidinger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gerald Schmidinger, Medical University of Vienna
- Investigators
- Gerald Schmidinger, Prof.Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383366
- Sponsor's protocol ID
- TOPOC
- Status last verified
- Mar 2021
- First submitted
- 7 May 2020
- Last updated
- 3 Mar 2021
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement and Accuracy of Different Devices for the Measurement of Corneal Thickness and Corneal Curvature in Patients With Keratoconus
- ClinicalTrials.gov ID
- NCT04383366
- Acronym / sponsor ID
- TOPOC
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gerald SchmidingerUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 12 May 2020 (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.
To compare repeatability, reproducibility and agreement of both, AS- OCT and Scheimpflug imaging, for the measurement of corneal curvature and corneal thickness in patients with keratoconus.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with keratoconus | – | Device: Pentacam® (Oculus, Inc., Wetzlar, Germany), Device: Casia II (Tomey Germany, Nürnberg), Device: Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with keratoconus will be recruited in the outpatient department of the Department of Ophthalmology.
Key inclusion criteria (3 listed)
- Men and women aged between 18 and 99 years
- Presence of keratoconus
- Signed informed consent
Key exclusion criteria (3 listed)
- Contact lens history within 5 days
- Pathologic changes of the lid or conjunctiva on slit-lamp examination
- History of corneal ocular surgery/Previous corneal cross-linking
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 |
|---|---|---|
| Pentacam® (Oculus, Inc., Wetzlar, Germany)Scheimpflug imaging | Device | Patients with keratoconus |
| Casia II (Tomey Germany, Nürnberg)Anterior segment optical coherence tomography | Device | Patients with keratoconus |
| Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)Anterior segment optical coherence tomography | Device | Patients with keratoconus |
Primary outcome
maximum K-value
Time frame: 1 day
4 secondary outcomes
Simulated minimum and maximum K-value
Time frame: 1 day
Mean K-values
Time frame: 1 day
Central Corneal thickness
Time frame: 1 day
Thinnest corneal point
Time frame: 1 day
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 3 Mar 2021.
- 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.
Gerald Schmidinger, Prof.Dr. principal investigator
Medical University of Vienna
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 Gerald Schmidinger 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: finished, as of the sponsor's last update on 3 Mar 2021. 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?
maximum K-value (time frame: 1 day). 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 3 Mar 2021.