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NCT Number: NCT06873399

Detection of Keratoconus Progression Using Machine Learning

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, State of Vienna, 1140, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

o

  • Kmax < 48 Dioptres (D): >0.5 D per year o
  • Kmax 48.01-53 D: >0.6 D per year o
  • Kmax 53.01-58 D: >0.8 D per year o
  • 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

Treatment and study plan

MS-39

Diagnostic Test

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).

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

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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