Deep Learning for Classification of Scheimpflug Corneal Tomography Images

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT04497207

Collaborator

(none)

1,669

Enrollment

Location

Actual Duration (Days)

3386.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases	Other: Scheimpflug Camera Corneal Tomography

Study Design

Study Type:

Observational

Actual Enrollment :

1669 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Aug 10, 2020

Actual Primary Completion Date :

Aug 20, 2020

Actual Study Completion Date :

Aug 25, 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.	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.

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.

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.

Outcome Measures

Primary Outcome Measures

Croppedm denoised, and resized to obtain four separate image stacks of 256×256 pixels [2 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 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 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.

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:

NCT04497207

Other Study ID Numbers:

17300437

First Posted:

Aug 4, 2020

Last Update Posted:

Oct 6, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Khaled Abdelazeem, Associate professor of Ophthalmology, Assiut University

Additional relevant MeSH terms:

Eye Diseases

Study Results

No Results Posted as of Oct 6, 2020