Deep Learning for Classification of Scheimpflug Corneal Tomography Images

Classification of Color-Coded Scheimpflug Camera Corneal Tomography Images Using Deep Learning

Keratoconus is a common disorder. An early diagnosis influences the disease prognosis in the affected patients and prevents postoperative complications in patients with keratoconus considering refractive surgery. Machine learning approaches have been widely used for image classification. Here, we will assess the ability of deep learning to enable high-performance image classification of the color-coded corneal maps obtained by Scheimpflug camera in patients with keratoconus, subclinical keratoconus, and normal individuals.

Study Overview

• Status: Completed
• Conditions: Eye Diseases
• Intervention / Treatment: Other: Scheimpflug Camera Corneal Tomography

• Study Type: Observational
• Enrollment (Actual): 1669

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with keratoconus, subclinical keratoconus & normal individuals from refractive surgery candidates.

Description

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 diopteric (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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.	Other: Scheimpflug Camera Corneal Tomography; Pentacam Sheimpflug system(Pentacam HR, Oculus Optikgeräte GmbH, software V.1.15r4 n7) is used for imaging of the anterir 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).	Other: Scheimpflug Camera Corneal Tomography; Pentacam Sheimpflug system(Pentacam HR, Oculus Optikgeräte GmbH, software V.1.15r4 n7) is used for imaging of the anterir 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.	Other: Scheimpflug Camera Corneal Tomography; Pentacam Sheimpflug system(Pentacam HR, Oculus Optikgeräte GmbH, software V.1.15r4 n7) is used for imaging of the anterir and posterior surfaces of the cornea to obtain corneal tomographic maps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Croppedm denoised, and resized to obtain four separate image stacks of 256×256 pixels	2 days

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2020
• Primary Completion (ACTUAL): August 20, 2020
• Study Completion (ACTUAL): August 25, 2020

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (ACTUAL): August 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Deep learning; Keratoconus; Scheimpflug camera; Corneal tomography
• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: 17300437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No