Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE
NCT ID: NCT03235856
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
972 participants
OBSERVATIONAL
2017-09-01
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Vision Institute Clinical Research Network
NETWORK
University Hospital, Antwerp
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jos Rozema
Senior researcher, Dpt of Ophthalmology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Antwerp University Hospital
Edegem, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Jimenez-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.
Jimenez-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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ECR-AS-2017-12
Identifier Type: -
Identifier Source: org_study_id