NCT03235856

Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 972 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: —

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

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

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-08-01
• Last updated: 2020-11-03

Locations

1 site across 1 country: Belgium