KeratoconusKKMS39PentaNCT05604443
Keratoconus Detection Using MS39 and Pentacam
An observational study of Keratoconus, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial summary
This retrospective study aims to investigate whether the MS39 and Pentacam are delivering comparable results in the diagnosis of keratoconus. In the future, these measurement devices could be interchangeable in usage. Read more about this study
- Who is it for?
- Ages 14 to 100 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- retrospective analyze
- How many people
- 173 participants
- Where
- 1 siteAustria
- Study dates
- 28 Dec 2022to 1 May 2023
- 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 14 to 100 years
- All sexes
- Child, Adult, Older adult
Study population: patients between 14 and 100 years who consult Keratokonus specialst.
Who may be able to join
- age older than 14 years
- patients who show up at Keratokonus consultation hours
Who cannot join
- age younger than 14 years
- age older than 100 years
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria
Linz, Upper Austria, 4020
About this study
Official title: Keratoconus Detection Using MS39 and Pentacam - a Retrospective Study
This retrospective study aims to investigate whether the MS39 and Pentacam are delivering comparable results in the diagnosis of keratoconus.
In the future, these measurement devices could be interchangeable in usage.
Read the detailed description
Keratoconus is a degenerative pathology of the cornea, which tends to progress. It comes along with central and paracentral thinning of the cornea as well as with an apical protrusion of the cornea. Keratoconus leads to vision loss. This pathology is diagnosed by using CE certified OCT technology in order to map the topography of the cornea. This process constitutes a really important step in the line of management of the keratoconus. MS39 and Pentacam are used for detection. Retrospectively, data will be investigated, in order to see if these measurement devices deliver comparable results. In the future, these measurement devices could be interchangeable in usage.
- Conditions
- Keratoconus
- Being tested
- retrospective analyze
- Keywords
- Keratoconus, Pentacam, MS39
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective analyzeOther
retrospective analyze of MS39 and Pentacam images
What is being measured
The primary outcome is the main question the study is designed to answer.
topography of the cornea
measurement of the topography of the cornea with MS39 and Pentacam
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start28 Dec 2022
- Primary completion1 Apr 2023
- Study completion1 May 2023
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Bolz, MD, Principal investigator, JKU Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604443
- Sponsor's protocol ID
- KUK-Ophthalmology-007
- Acronym
- KKMS39Penta
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2022
- Last updated
- 13 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 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keratoconus Detection Using MS39 and Pentacam - a Retrospective Study
- ClinicalTrials.gov ID
- NCT05604443
- Acronym / sponsor ID
- KKMS39Penta / KUK-Ophthalmology-007
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Pentacam, MS39
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 3 Nov 2022 (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.
This retrospective study aims to investigate whether the MS39 and Pentacam are delivering comparable results in the diagnosis of keratoconus.
In the future, these measurement devices could be interchangeable in usage.
Detailed description
Keratoconus is a degenerative pathology of the cornea, which tends to progress. It comes along with central and paracentral thinning of the cornea as well as with an apical protrusion of the cornea. Keratoconus leads to vision loss. This pathology is diagnosed by using CE certified OCT technology in order to map the topography of the cornea. This process constitutes a really important step in the line of management of the keratoconus. MS39 and Pentacam are used for detection. Retrospectively, data will be investigated, in order to see if these measurement devices deliver comparable results. In the future, these measurement devices could be interchangeable in usage.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients between 14 and 100 years who consult Keratokonus specialst.
Key inclusion criteria (2 listed)
- age older than 14 years
- patients who show up at Keratokonus consultation hours
Key exclusion criteria (2 listed)
- age younger than 14 years
- age older than 100 years
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 |
|---|---|---|
| retrospective analyzeretrospective analyze of MS39 and Pentacam images | Other | – |
Primary outcome
topography of the cornea
Time frame: 12 months
measurement of the topography of the cornea with MS39 and Pentacam
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 13 Oct 2023.
- Individual participant dataSharing planned: No
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Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
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A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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Enrolling by invitationObservational study
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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.
Matthias Bolz, MD principal investigator
JKU Linz
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 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 2 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 13 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?
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?
topography of the cornea (time frame: 12 months). 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 13 Oct 2023.