KeratoconusNCT04578184
Epithelial Thickness Map
A study testing Corneal epithelial thickness measurements in people with Keratoconus, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
In keratoconic eyes, the corneal epithelium shows a localized thinning over the cone that is surrounded by an annulus of epithelial thickening. It has been postulated that epithelial thickness mapping can be a sensitive tool for the keratoconus diagnosis. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal epithelial thickness measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 15 Oct 2020to Mar 2021
- Phase
- Interventional
- 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 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with diagnosed keratoconus (diagnosed using tomography and topography map changes and slit-lamp changes) and patients with healthy cornea
- Age 21 and older
- Signed informed consent
Who cannot join
- Previous ocular surgery
- Associated corneal pathologies (e.g. trauma, edema, scarring)
- In women of childbearing age, a pregnancy test will be performed before inclusion into the study.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Hanusch Hospital, Ophthalmology Department
Vienna, 1140
Oliver Findl, Prof. MD, +43 1 91021 57564, office@viros.at
About this study
Official title: Comparison of Two Optical Coherence Tomography Devices in Corneal Epithelial Thickness Maps
In keratoconic eyes, the corneal epithelium shows a localized thinning over the cone that is surrounded by an annulus of epithelial thickening. It has been postulated that epithelial thickness mapping can be a sensitive tool for the keratoconus diagnosis. In keratoconus screening the 5 mm diameter of the corneal centrum may be sufficient while studies have shown that the cone apex is located in this area.
Aim of this study is to assess agreement and repeatability of epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas.
Read more
Secondary objective is to evaluate the differences between healthy and keratoconus eyes using epithelial thickness map data.
This is a prospective monocentric study that includes patients divided into two groups: patients with keratoconus and a control group formed out of patients without corneal pathologies. For each patient only one eye will be included and corneal measurements will be performed, focused on the corneal epithelium thickness.
Read the detailed description
In total 50 eyes of 50 patients will be included, divided into two groups: study group comprised of 20 eyes with diagnosed keratoconus and a control group formed out of 30 healthy eyes.
Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation. After each measurement patients will be asked to blink in order to allow adequate tear-film recovery. Each patient will be measured three times with both devices. Only one visit will be necessary.
The order in which the measurements will be performed (Anterion or MS-39) will be randomised using randomised.org.
The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces.
Main outcome variable:
- Mean differences in central corneal epithelial thickness between the devices investigated (+ limits of agreement (1.96xSD) between the investigated devices)
Secondary outcome variables:
- Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation of the two devices
- Comparison in epithelial thickness between normal and keratoconus eyes
- Sensitivity and specificity of swept-source OCT device in keratoconus diagnosis
- Conditions
- Keratoconus
- Being tested
- Corneal epithelial thickness measurements
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal epithelial thickness measurementsDiagnostic test
Corneal epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas.
| Study group | Role | What they receive |
|---|---|---|
| Epithelial thickness map evaluation in keratoconus patients | Other | Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation Each patient will be measured three times with both devices. The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces. Receives: Diagnostic Test: Corneal epithelial thickness measurements |
| Epithelial thickness map evaluation in healthy cornea patients | Other | Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation Each patient will be measured three times with both devices. The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces. Receives: Diagnostic Test: Corneal epithelial thickness measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between two ss-OCT devices in corneal epithelial thickness measurements (LoA in micrometer)
Measured: 6 months
Secondary outcomes (1)
Repeatability between two ss-OCT devices in corneal epithelial thickness measurements (determination of within-subject standard deviation and Coefficient of variation)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionMar 2021 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Prof., MD, Principal investigator, Head of Department of Ophthalmology, Professor, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578184
- Sponsor's protocol ID
- Epithelial thickness map
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2020
- Last updated
- 12 Oct 2020
- 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 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Optical Coherence Tomography Devices in Corneal Epithelial Thickness Maps
- ClinicalTrials.gov ID
- NCT04578184
- Acronym / sponsor ID
- Epithelial thickness map
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 8 Oct 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.
In keratoconic eyes, the corneal epithelium shows a localized thinning over the cone that is surrounded by an annulus of epithelial thickening. It has been postulated that epithelial thickness mapping can be a sensitive tool for the keratoconus diagnosis. In keratoconus screening the 5 mm diameter of the corneal centrum may be sufficient while studies have shown that the cone apex is located in this area.
Aim of this study is to assess agreement and repeatability of epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas.
Secondary objective is to evaluate the differences between healthy and keratoconus eyes using epithelial thickness map data.
This is a prospective monocentric study that includes patients divided into two groups: patients with keratoconus and a control group formed out of patients without corneal pathologies. For each patient only one eye will be included and corneal measurements will be performed, focused on the corneal epithelium thickness.
Detailed description
In total 50 eyes of 50 patients will be included, divided into two groups: study group comprised of 20 eyes with diagnosed keratoconus and a control group formed out of 30 healthy eyes.
Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation. After each measurement patients will be asked to blink in order to allow adequate tear-film recovery. Each patient will be measured three times with both devices. Only one visit will be necessary.
The order in which the measurements will be performed (Anterion or MS-39) will be randomised using randomised.org.
The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces.
Main outcome variable:
- Mean differences in central corneal epithelial thickness between the devices investigated (+ limits of agreement (1.96xSD) between the investigated devices)
Secondary outcome variables:
- Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation of the two devices
- Comparison in epithelial thickness between normal and keratoconus eyes
- Sensitivity and specificity of swept-source OCT device in keratoconus diagnosis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epithelial thickness map evaluation in keratoconus patients | Other | Diagnostic Test: Corneal epithelial thickness measurementsPatients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation Each patient will be measured three times with both devices. The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces. |
| Epithelial thickness map evaluation in healthy cornea patients | Other | Diagnostic Test: Corneal epithelial thickness measurementsPatients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation Each patient will be measured three times with both devices. The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with diagnosed keratoconus (diagnosed using tomography and topography map changes and slit-lamp changes) and patients with healthy cornea
- Age 21 and older
- Signed informed consent
Key exclusion criteria (3 listed)
- Previous ocular surgery
- Associated corneal pathologies (e.g. trauma, edema, scarring)
- In women of childbearing age, a pregnancy test will be performed before inclusion into the study.
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 |
|---|---|---|
| Corneal epithelial thickness measurementsCorneal epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas. | Diagnostic test | Epithelial thickness map evaluation in healthy cornea patients, Epithelial thickness map evaluation in keratoconus patients |
Primary outcome
Agreement between two ss-OCT devices in corneal epithelial thickness measurements (LoA in micrometer)
Time frame: 6 months
1 secondary outcome
Repeatability between two ss-OCT devices in corneal epithelial thickness measurements (determination of within-subject standard deviation and Coefficient of variation)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- 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.
Oliver Findl, Prof., MD principal investigator
Head of Department of Ophthalmology, Professor, Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal epithelial thickness measurements in people with Keratoconus, run by Vienna Institute for Research in Ocular Surgery 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: status not confirmed, as of the sponsor's last update on 12 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Findl, Prof., MD (+43 1 91021-84611, hkh.augen.abt@wgkk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between two ss-OCT devices in corneal epithelial thickness measurements (LoA in micrometer) (time frame: 6 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 12 Oct 2020.