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OpenTrials
Completed

NCT Number: NCT04582253

Pix2pix Networks for Scheimpflug Corneal Tomography Image Generation

Computer-aided medical image analysis has advantages, but requires large amounts of training data, which are scarce and costly to obtain, are subject to privacy concerns, and are often highly imbalanced, with over-representation of common conditions and poor representation of rare conditions. Consequently, some methods have been proposed to generate artificial medical images using generative adversarial networks (GANs). Computer aided diagnosis of keratoconus is an emerging research field that may benefit greatly from medical image synthesis, which can affordably provide an arbitrary number of sufficiently diverse synthetic images that mimic real Pentacam images. A new conditional GAN, the pix2pix cGAN, has not been used in this context to date. Here, investigators will assess the efficacy of a cGAN implementing pix2pix image translation for image synthesis of color-coded Pentacam 4-map refractive displays of clinical and subclinical keratoconus as well as normal corneas.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine

Asyut, 71515, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Keratoconus group:
  • Presence of a central protrusion of the cornea with Fleischer ring, Vogt striae, or both by slitlamp examination.
  • irregular cornea determined by distorted keratometry mires and distortion of retinoscopic red reflex or both in addition to the following topographic findings as summarized by Pińero and colleagues :
  • focal steepening located in a zone of protrusion surrounded by concentrically decreasing power zones
  • focal areas with dioptric (D) values >47.0D
  • inferior- superior(I-S) asymmetry measured to be > 1.4 D
  • Angling of the hemimeridians in an asymmetric or broken bowtie pattern with skewing of the steepest radial axis(SRAX) .

Suspicious group:

  • Defined as subtle corneal tomographic changes as the aforementioned keratoconus abnormalities in the absence of slit- lamp or visual acuity changes typical of keratoconus (forme fruste keratoconus).

Normal group:

  • Refractive surgery candidates
  • Refractive error of less than 8.0 D sphere
  • Less than 3.0 D of astigmatism
  • without clinical, topographic or tomographic signs of keratoconus or suspect keratoconus.

Exclusion criteria

  • • Systemic disease
  • Other corneal disease such as pellucid marginal degeneration
  • History of trauma
  • Corneal surgery such as corneal cross- linking for progressive keratoconus.

Treatment and study plan

Scheimpflug Camera Corneal Tomography

Diagnostic Test

Pentacam Sheimpflug system(Pentacam HR, Oculus Optikgeräte GmbH, software V.1.15r4 n7) is used for imaging of the anterior and posterior surfaces of the cornea to obtain corneal tomographic maps.

Primary outcomes

  1. Scheimpflug camera color-coded corneal tomography images created by pix2pix conditional adversarial network (pix2pix cGAN)

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Pix2pix Conditional Generative Adversarial Networks for Scheimpflug Camera Color-coded Corneal Tomography Image Generation

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2020
Registry last updated
Oct 19, 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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