Detection of Keratoconus Progression Using Machine Learning

March 6, 2025 updated by: Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Machine Learning Assisted Prediction of Keratoconus Progression Using Topographic and Volumetric Data: a Retrospective Study

Keratoconus (KC) is a bilateral ocular disease characterized by progressive thinning and steepening of the cornea, usually in its inferotemporal region. The disease often occurs asymmetrically as one eye is more severely affected by the condition. The changes underlying KC lead to the generation of irregular astigmatism resulting in diminished visual acuity of the patients and can even lead to axial corneal scarring in advanced stages. The disease usually occurs in the second or third decade of life, but can develop at any age. KC is a complex condition involving environmental factors such as age, eye rubbing, contact lens use, atopy, sun exposure, hormones, toxins, as well as a genetic component. However, how these factors contribute to the disease is still unknown and intraindividual differences might exist.

KC can be categorized into different forms based on the stage of the disease. In clinical KC, there are both topographic and slit lamp findings of the disease.

The importance of corneal epithelial imaging in the diagnosis of keratoconus has been further demonstrated in several clinical studies. As new anterior segment optical coherence tomography (AS-OCT) devices provide more detailed measurements for instance of the corneal epithelium. This layer could therefore be an interesting marker for the prediction of KC progression and contribute to earlier diagnosis as well as better outcome of the disease.

The aim of this retrospective study is therefore to determine whether different topographical and volumetric data, for instance epithelial thickness maps (ETM), can be reliably used to predict the progression of KC using a machine learning algorithm.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Vienna Institute for Research in Ocular Surgery (VIROS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with keratoconus that had at least two measurement using the MS-39 device

Description

Inclusion Criteria:

  • Patients with KC progression as defined dependent on Kmax/year:

o

  1. Kmax < 48 Dioptres (D): >0.5 D per year o
  2. Kmax 48.01-53 D: >0.6 D per year o
  3. Kmax 53.01-58 D: >0.8 D per year o
  4. Kmax > 58 D: >1.5 D per year - Non progressive group: Patients with stable KC (KC progression dependent on Kmax < than the values described above/year)

Exclusion Criteria:

  • Relevant other ophthalmic diseases that are likely to influence the measurement outcome like corneal scars or epithelial dystrophies
  • Too few measurements/too short follow-up to define progression of KC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Progressive Keratoconus
Patients with progressive keratokonus, based on a one-year change in Kmax values
Diagnostic test: MS-39
The MS-39 (Costruzione Strumenti Oftalmici, Firenze, Italy) is a device for anterior segment analysis of the eye, which combines Placido disc corneal topography and high-resolution SD-OCT. The device provides information on pachymetry, elevation, curvature, and dioptric power of both corneal surfaces. To obtain corneal topography, 22 Placido disc rings are emanated from a laser emitted diode (LED) light source at 635 nanometres (nm). The central 10 millimetres of the anterior corneal surface are covered. Epithelial thickness maps are calculated for different sectors (central, paracentral inferior/superior/nasal/temporal).
Non-progressive Keratoconus
Patients with non-progressive keratokonus, based on a one-year change in Kmax values
Diagnostic test: MS-39
The MS-39 (Costruzione Strumenti Oftalmici, Firenze, Italy) is a device for anterior segment analysis of the eye, which combines Placido disc corneal topography and high-resolution SD-OCT. The device provides information on pachymetry, elevation, curvature, and dioptric power of both corneal surfaces. To obtain corneal topography, 22 Placido disc rings are emanated from a laser emitted diode (LED) light source at 635 nanometres (nm). The central 10 millimetres of the anterior corneal surface are covered. Epithelial thickness maps are calculated for different sectors (central, paracentral inferior/superior/nasal/temporal).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of the machine learning algorithm on the final test data set
Time Frame: through study completion, one year
Sensitivity of the machine learning algorithm on the final test data set to differentiate between progressive/non-progressive eyes based on Kmax-change per year
through study completion, one year
Specificity of the machine learning algorithm on the final test data set
Time Frame: through study completion, one year
Specificity of the machine learning algorithm on the final test data set to differentiate between progressive/non-progressive eyes based on Kmax-change per year
through study completion, one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vienna Institute for Research in Ocular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 2, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK_24_158_VK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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