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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04582253
Other study ID # 17300483
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date October 1, 2020

Study information

Verified date October 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 923
Est. completion date October 1, 2020
Est. primary completion date August 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Pinero 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Faculty of Medicine Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scheimpflug camera color-coded corneal tomography images created by pix2pix conditional adversarial network (pix2pix cGAN) 1 day
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