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Completed

NCT Number: NCT03235856

Retrospective Digital Computer Analysis of Keratoconus Evolution - 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

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Key information

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital

Edegem, 2650, Belgium

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. To improve the predictive model for keratoconus progression speed so it can work using only one single measurement

    Time frame: 18 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • European Vision Institute Clinical Research Network

Registry information

Acronym: REDCAKE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 1, 2017
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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