KeratoconusREDCAKENCT03235856
Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
An observational study of Keratoconus, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The purpose of this study is to create a database of keratoconic eyes with two or more corneal topographies/tomographies, at least 5 months apart Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Keratoconus
- How many people
- 972 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2017to 31 Dec 2018
- 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 12 to 40 years
- All sexes
- Child, Adult
Study population: This study involves a retrospective analysis of data recorded during routine clinical follow-up of keratoconus patients. As such, the impact for the patient is minimal as no additions tests need to be performed
Who may be able to join
- Age between 12-40 years.
- Clinically diagnosed mild or moderate keratoconus in one or both eyes
- Two or more Scheimpflug measurements (type Pentacam HR, Pentacam AXL, Ziemer Galilei, CSO Sirius) of good technical quality, separated at least five months apart.
Who cannot join
- Corneal scarring present in both eyes.
- Known corneal or retinal pathologies, apart from keratoconus
- Known ocular procedures/ treatments (including crosslinking)
- Known systemic diseases (e.g. diabetes, MS, HIV/AIDS, hypertension,…), except allergies
- Change in contact lenses between measurements (e.g. start wearing lenses, change from corneal to scleral lenses, etc.)
- Fluorescein drops instilled into the eye before Scheimpflug measurement.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to create a database of keratoconic eyes with two or more corneal topographies/tomographies, at least 5 months apart
Read the detailed description
Title: Keratometry values such as K1, K2 and the angle between these two; Value and location of the thinnest corneal point; Pachymetry progression (radial change of pachymetry); IS value (i.e., ratio of average curvature in superior and inferior sections)
Description:
The primary endpoint is to obtain a database, containing at least two valid corneal biometry measurements (Scheimpflug) recorded at least 5 months apart, for a predetermined number of suitable keratoconus patients.
These data will be used to create a personalized three-dimensional model of the cornea at each time point, which permits classifying corneas according to shape and stage, as well as assessing the influence of patient age, gender, family history and ophthalmic habits (e.g. eye rubbing) on keratoconus progression. Based on corneal changes over time, an estimate of the underlying biomechanical changes will be made. All these data will then be combined to develop software for automated keratoconus detection and progression risk assessment to help ophthalmologists decide when to perform crosslinking on their patients.
The primary variables are the elevation parameters derived directly from the Scheimpflug measuring device export files, along with the demographic and medical information (if available).
Time frame: 5 months
Once a predictive model for keratoconus progression speed based on multiple measurements, this can be improved to make predictions based on a single measurement. Furthermore, the database obtained in this work will also be a valuable resource to analyse the variation in keratoconus shape, which may lead to an improved classification of keratoconus types
- Conditions
- Keratoconus
- Medical subject headings
- Keratoconus
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 patients | This study involves a retrospective analysis of data recorded during routine clinical follow-up of keratoconus patients. As such, the impact for the patient is minimal as no additional tests need to be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain a database, containing at least two valid corneal Scheimpflug measurements recorded at least 5 months apart, of 1500 keratoconus patients.
These data will be used to create a personalized three-dimensional model of the cornea at each time point, which permits classifying corneas according to shape and stage, as well as assessing the influence of patient age, gender, family history and ophthalmic habits (e.g. eye rubbing) on keratoconus progression. Based on corneal changes over time, an estimate of the underlying biomechanical changes will be made.
Measured: 5 months
To develop software to automatically detect keratoconus and estimate the keratoconus progression speed
The data from Outcome 1 will be combined to develop software for automated keratoconus detection and progression risk assessment to help ophthalmologists decide when to perform cross-linking on their patients.
Measured: 18 months
Secondary outcomes (1)
To improve the predictive model for keratoconus progression speed so it can work using only one single measurement
Once a predictive model for keratoconus progression speed based on multiple measurements, this can be improved to make predictions based on a single measurement.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Other
- Time perspective
- Retrospective
- Enrolment
- 972 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- European Vision Institute Clinical Research Network
- Responsible party
- Principal investigator, Jos Rozema, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235856
- Sponsor's protocol ID
- ECR-AS-2017-12
- Acronym
- REDCAKE
- Status last verified
- Nov 2020
- First submitted
- 27 Jul 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koppen C, Jimenez-Garcia M, Kreps EO, Ni Dhubhghaill S, Rozema JJ; REDCAKE Study Group. Definitions for Keratoconus Progression and Their Impact on Clinical Practice. Eye Contact Lens. 2024 Jan 1;50(1):1-9. doi: 10.1097/ICL.0000000000001038. Epub 2023 Oct 9.
PubMed 37816249Jimenez-Garcia M, Kreps EO, Ni Dhubhghaill S, Koppen C, Rozema JJ; REDCAKE Study Group. Determining the Most Suitable Tomography-Based Parameters to Describe Progression in Keratoconus. The Retrospective Digital Computer Analysis of Keratoconus Evolution Project. Eye Contact Lens. 2021 Sep 1;47(9):486-493. doi: 10.1097/ICL.0000000000000800.
PubMed 34050086Jimenez-Garcia M, Ni Dhubhghaill S, Koppen C, Varssano D, Rozema JJ; and The REDCAKE Study Group. Baseline Findings in the Retrospective Digital Computer Analysis of Keratoconus Evolution (REDCAKE) Project. Cornea. 2021 Feb 1;40(2):156-167. doi: 10.1097/ICO.0000000000002389.
PubMed 32541189
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
- ClinicalTrials.gov ID
- NCT03235856
- Acronym / sponsor ID
- REDCAKE / ECR-AS-2017-12
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 972 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- European Vision Institute Clinical Research Network
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Aug 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 purpose of this study is to create a database of keratoconic eyes with two or more corneal topographies/tomographies, at least 5 months apart
Detailed description
Title: Keratometry values such as K1, K2 and the angle between these two; Value and location of the thinnest corneal point; Pachymetry progression (radial change of pachymetry); IS value (i.e., ratio of average curvature in superior and inferior sections)
Description:
The primary endpoint is to obtain a database, containing at least two valid corneal biometry measurements (Scheimpflug) recorded at least 5 months apart, for a predetermined number of suitable keratoconus patients.
These data will be used to create a personalized three-dimensional model of the cornea at each time point, which permits classifying corneas according to shape and stage, as well as assessing the influence of patient age, gender, family history and ophthalmic habits (e.g. eye rubbing) on keratoconus progression. Based on corneal changes over time, an estimate of the underlying biomechanical changes will be made. All these data will then be combined to develop software for automated keratoconus detection and progression risk assessment to help ophthalmologists decide when to perform crosslinking on their patients.
The primary variables are the elevation parameters derived directly from the Scheimpflug measuring device export files, along with the demographic and medical information (if available).
Time frame: 5 months
Once a predictive model for keratoconus progression speed based on multiple measurements, this can be improved to make predictions based on a single measurement. Furthermore, the database obtained in this work will also be a valuable resource to analyse the variation in keratoconus shape, which may lead to an improved classification of keratoconus types
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keratoconus patients | – | –This study involves a retrospective analysis of data recorded during routine clinical follow-up of keratoconus patients. As such, the impact for the patient is minimal as no additional tests need to be performed |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- This study involves a retrospective analysis of data recorded during routine clinical follow-up of keratoconus patients. As such, the impact for the patient is minimal as no additions tests need to be performed
Key inclusion criteria (3 listed)
- Age between 12-40 years.
- Clinically diagnosed mild or moderate keratoconus in one or both eyes
- Two or more Scheimpflug measurements (type Pentacam HR, Pentacam AXL, Ziemer Galilei, CSO Sirius) of good technical quality, separated at least five months apart.
Key exclusion criteria (6 listed)
- Corneal scarring present in both eyes.
- Known corneal or retinal pathologies, apart from keratoconus
- Known ocular procedures/ treatments (including crosslinking)
- Known systemic diseases (e.g. diabetes, MS, HIV/AIDS, hypertension,…), except allergies
- Change in contact lenses between measurements (e.g. start wearing lenses, change from corneal to scleral lenses, etc.)
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
To obtain a database, containing at least two valid corneal Scheimpflug measurements recorded at least 5 months apart, of 1500 keratoconus patients.
Time frame: 5 months
These data will be used to create a personalized three-dimensional model of the cornea at each time point, which permits classifying corneas according to shape and stage, as well as assessing the influence of patient age, gender, family history and ophthalmic habits (e.g. eye rubbing) on keratoconus progression. Based on corneal changes over time, an estimate of the underlying biomechanical changes will be made.
To develop software to automatically detect keratoconus and estimate the keratoconus progression speed
Time frame: 18 months
The data from Outcome 1 will be combined to develop software for automated keratoconus detection and progression risk assessment to help ophthalmologists decide when to perform cross-linking on their patients.
1 secondary outcome
To improve the predictive model for keratoconus progression speed so it can work using only one single measurement
Time frame: 18 months
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 Nov 2020.
- Derived from this study: PubMed 37816249Koppen C, Jimenez-Garcia M, Kreps EO, Ni Dhubhghaill S, Rozema JJ; REDCAKE Study Group. Definitions for Keratoconus Progression and Their Impact on Clinical Practice. Eye Contact Lens. 2024 Jan 1;50(1):1-9. doi: 10.1097/ICL.0000000000001038. Epub 2023 Oct 9.
- Derived from this study: PubMed 34050086Jimenez-Garcia M, Kreps EO, Ni Dhubhghaill S, Koppen C, Rozema JJ; REDCAKE Study Group. Determining the Most Suitable Tomography-Based Parameters to Describe Progression in Keratoconus. The Retrospective Digital Computer Analysis of Keratoconus Evolution Project. Eye Contact Lens. 2021 Sep 1;47(9):486-493. doi: 10.1097/ICL.0000000000000800.
- Derived from this study: PubMed 32541189Jimenez-Garcia M, Ni Dhubhghaill S, Koppen C, Varssano D, Rozema JJ; and The REDCAKE Study Group. Baseline Findings in the Retrospective Digital Computer Analysis of Keratoconus Evolution (REDCAKE) Project. Cornea. 2021 Feb 1;40(2):156-167. doi: 10.1097/ICO.0000000000002389.
- 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 University Hospital, Antwerp at 1 site in Belgium.
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 6 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 Nov 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 Belgium. 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?
To obtain a database, containing at least two valid corneal Scheimpflug measurements recorded at least 5 months apart, of 1500 keratoconus patients. (time frame: 5 months). The study lists 2 primary outcomes in all. 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 NCT03235856, which also lists 3 linked publications.
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 Nov 2020.