NCT04497207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,669

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

10 days

First QC Date

July 30, 2020

Last Update Submit

October 5, 2020

Conditions

Eye Diseases

Keywords

KeratoconusDeep learningScheimpflug cameraCorneal tomography

Outcome Measures

Primary Outcomes (1)

  • Croppedm denoised, and resized to obtain four separate image stacks of 256×256 pixels

    2 days

Study Arms (3)

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

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

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

Interventions

Scheimpflug Camera Corneal TomographyOTHER

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.

KeratoconusNormalSubclinical keratoconus

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Systemic disease
  • Other corneal disease such as pellucid marginal degeneration
  • History of trauma
  • Corneal surgery such as corneal cross- linking for progressive keratoconus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Eye DiseasesKeratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Ophthalmology

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 4, 2020

Study Start

August 10, 2020

Primary Completion

August 20, 2020

Study Completion

August 25, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)