KeratoconusNCT02023619
Corneal Epithelial and Stromal Thickness Distribution in Keratoconus
An observational study of Keratoconus and Astigmatism, run by SynsLaser Kirurgi AS at 1 site in Norway.
Trial summary
The purpose of the study was to identify corneal epithelial- and stromal-thickness distribution patterns in keratoconic eyes using spectral-domain-optical coherence tomography (SD-OCT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Astigmatism
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2013to Sep 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 eyes with diagnosed keratoconus and 20 healthy eyes with astigmatism >2.0 D
Who may be able to join
- Keratoconus group: Confirmed diagnosis of keratoconus
- Astigmatism group: Healthy eyes with astigmatism of >2.0 D
Who cannot join
- Keratoconus group: Keratoconus > stage 3 on Krumeich scale
- Astigmatism group: No signs of keratoconus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Corneal Epithelial and Stromal Thickness Distributions Between Eyes With Keratoconus and Healthy Eyes With Corneal Astigmatism >2.0 D
The purpose of the study was to identify corneal epithelial- and stromal-thickness distribution patterns in keratoconic eyes using spectral-domain-optical coherence tomography (SD-OCT).
Study Hypothesis: SD-OCT provides necessary details about the distribution of corneal epithelial and stromal thicknesses for identification of a pattern characteristic for early keratoconus.
Read the detailed description
Purpose of the study: To characterize epithelial and stromal thickness distribution in keratoconic eyes and to develop epithelial and stromal thickness-based variables for keratoconus detection.
Methodology: SD-OCT corneal scans of 20 eyes with keratoconus (group 1) and 20 healthy eyes with > 2 diopters (D) of corneal astigmatism as controls (group 2) are studied. Keratoconus patients referred to the Eye Dpt. of the University Hospital North Norway for CXL (Corneal collagen cross-linking)- treatment and healthy subjects seeking preoperative evaluation for refractive surgery at SynsLaser® Kirurgi AS Tromsø clinic are examined by corneal SD-OCT as a part of their routine examination. Analysis of their SD-OCT corneal scans is used for the purpose of this study.Two cross-sectional meridional corneal profiles (along steepest and flattest meridians, located by a Scheimpflug-based corneal topography) for each individual are obtained by using a RTVue100® (Optovue Inc. Fremont, California, USA), 26000-Hz SD-OCT across the central 6mm diameter of the cornea.
- Conditions
- Keratoconus, Astigmatism
- Keywords
- Keratoconus, Astigmatism, Cornea, SD-OCT
- Medical subject headings
- Keratoconus, Astigmatism, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Keratoconus | Eyes with confirmed keratoconus diagnosis | |
| Astigmatism >2.0 D | Healthy eyes with astigmatism >2.0 D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cornea epithelial thickness distribution
A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination
Measured: Up to 24 weeks
Secondary outcomes (1)
Cornea stromal thickness distribution
A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 crossover
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- SynsLaser Kirurgi AS
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Aleksandar Stojanovic, SynsLaser Kirurgi AS
- Investigators
- Aleksandar Stojanovic, MD, Principal investigator, SynsLaser Kirurgi AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023619
- Sponsor's protocol ID
- REK NORD 2013/758
- Other IDs
- SL 1
- Status last verified
- Apr 2019
- First submitted
- 12 Dec 2013
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhou W, Stojanovic A. Comparison of corneal epithelial and stromal thickness distributions between eyes with keratoconus and healthy eyes with corneal astigmatism >/= 2.0 D. PLoS One. 2014 Jan 28;9(1):e85994. doi: 10.1371/journal.pone.0085994. eCollection 2014.
PubMed 24489687
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Corneal Epithelial and Stromal Thickness Distributions Between Eyes With Keratoconus and Healthy Eyes With Corneal Astigmatism >2.0 D
- ClinicalTrials.gov ID
- NCT02023619
- Acronym / sponsor ID
- REK NORD 2013/758
- Conditions
- Keratoconus, Astigmatism
- Keywords
- Keratoconus, Astigmatism, Cornea, SD-OCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SynsLaser Kirurgi ASUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Dec 2013 (estimated)
- 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 purpose of the study was to identify corneal epithelial- and stromal-thickness distribution patterns in keratoconic eyes using spectral-domain-optical coherence tomography (SD-OCT).
Study Hypothesis: SD-OCT provides necessary details about the distribution of corneal epithelial and stromal thicknesses for identification of a pattern characteristic for early keratoconus.
Detailed description
Purpose of the study: To characterize epithelial and stromal thickness distribution in keratoconic eyes and to develop epithelial and stromal thickness-based variables for keratoconus detection.
Methodology: SD-OCT corneal scans of 20 eyes with keratoconus (group 1) and 20 healthy eyes with > 2 diopters (D) of corneal astigmatism as controls (group 2) are studied. Keratoconus patients referred to the Eye Dpt. of the University Hospital North Norway for CXL (Corneal collagen cross-linking)- treatment and healthy subjects seeking preoperative evaluation for refractive surgery at SynsLaser® Kirurgi AS Tromsø clinic are examined by corneal SD-OCT as a part of their routine examination. Analysis of their SD-OCT corneal scans is used for the purpose of this study.Two cross-sectional meridional corneal profiles (along steepest and flattest meridians, located by a Scheimpflug-based corneal topography) for each individual are obtained by using a RTVue100® (Optovue Inc. Fremont, California, USA), 26000-Hz SD-OCT across the central 6mm diameter of the cornea.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keratoconus | – | –Eyes with confirmed keratoconus diagnosis |
| Astigmatism >2.0 D | – | –Healthy eyes with astigmatism >2.0 D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 eyes with diagnosed keratoconus and 20 healthy eyes with astigmatism >2.0 D
Key inclusion criteria (2 listed)
- Keratoconus group: Confirmed diagnosis of keratoconus
- Astigmatism group: Healthy eyes with astigmatism of >2.0 D
Key exclusion criteria (2 listed)
- Keratoconus group: Keratoconus > stage 3 on Krumeich scale
- Astigmatism group: No signs of keratoconus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cornea epithelial thickness distribution
Time frame: Up to 24 weeks
A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination
1 secondary outcome
Cornea stromal thickness distribution
Time frame: Up to 24 weeks
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 4 Apr 2019.
- Results publication: PubMed 24489687Zhou W, Stojanovic A. Comparison of corneal epithelial and stromal thickness distributions between eyes with keratoconus and healthy eyes with corneal astigmatism >/= 2.0 D. PLoS One. 2014 Jan 28;9(1):e85994. doi: 10.1371/journal.pone.0085994. eCollection 2014.
- 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.
Aleksandar Stojanovic, MD principal investigator
SynsLaser Kirurgi AS
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 and Astigmatism, run by SynsLaser Kirurgi AS at 1 site in Norway.
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 4 Apr 2019. 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 Norway. 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?
Cornea epithelial thickness distribution (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02023619, which also lists 1 linked publication.
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 4 Apr 2019.