Pix2pix Networks for Scheimpflug Corneal Tomography Image Generation

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT04582253
Collaborator
(none)
923
1
2
460.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Scheimpflug Camera Corneal Tomography

Study Design

Study Type:
Observational
Actual Enrollment :
923 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Pix2pix Conditional Generative Adversarial Networks for Scheimpflug Camera Color-coded Corneal Tomography Image Generation
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Aug 20, 2020
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Keratoconus

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.

Diagnostic Test: Scheimpflug Camera Corneal Tomography
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.

Subclinical keratoconus

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).

Diagnostic Test: Scheimpflug Camera Corneal Tomography
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.

Normal

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.

Diagnostic Test: Scheimpflug Camera Corneal Tomography
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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Khaled Abdelazeem, Associate professor of Ophthalmology, Assiut University
ClinicalTrials.gov Identifier:
NCT04582253
Other Study ID Numbers:
  • 17300483
First Posted:
Oct 9, 2020
Last Update Posted:
Oct 19, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Khaled Abdelazeem, Associate professor of Ophthalmology, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2020