Pix2pix Networks for Scheimpflug Corneal Tomography Image Generation

Completed

• Conditions: Eye Diseases
• Interventions: Diagnostic Test: Scheimpflug Camera Corneal Tomography

• Registration Number: NCT04582253
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2020-08-20
• Status Verified: 2020-10
• Study Completion: 2020-10-01
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-09
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 923

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subclinical keratoconus	Scheimpflug Camera Corneal Tomography	Defined as subtle corneal tomographic changes as the aforementioned keratoconus abnormalities in the absence of slit- lamp or visual acuity changes typical of keratoconus (subclinical keratoconus).
Normal	Scheimpflug Camera Corneal Tomography	This group comprised refractive surgery candidates and subjects applying for a contact lens fitting with a refractive error of less than 8.0 D sphere with less than 3.0 D of astigmatism and without clinical, topographic or tomographic signs of keratoconus nor suspected keratoconus.
Keratoconus	Scheimpflug Camera Corneal Tomography	Those with a clinical diagnosis of keratoconus such as: a) the presence of a central protrusion of the cornea with Fleischer ring, Vogt striae, or both by slitlamp examination.(b) an 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 or angling of the hemimeridians in an asymmetric or broken bowtie pattern with skewing of the steepest radial axis (SRAX) 2.

Primary Outcome Measures

Name	Time	Method
Scheimpflug camera color-coded corneal tomography images created by pix2pix conditional adversarial network (pix2pix cGAN)	1 day

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt