Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE (REDCAKE)

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

Study Overview

• Status: Completed
• Conditions: Keratoconus

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 Type: Observational
• Enrollment (Actual): 972

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: European Vision Institute Clinical Research Network

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: ECR-AS-2017-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No