NCT03235856

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
972

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

July 27, 2017

Last Update Submit

November 2, 2020

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

    18 months

Study Arms (1)

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

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, 2650, Belgium

Location

Related Publications (3)

  • 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.

    PMID: 37816249DERIVED

  • 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.

    PMID: 34050086DERIVED

  • 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.

    PMID: 32541189DERIVED

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher, Dpt of Ophthalmology

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 1, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)