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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04497207
Other study ID # 17300437
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 10, 2020
Est. completion date August 25, 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

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.


Recruitment information / eligibility

Status Completed
Enrollment 1669
Est. completion date August 25, 2020
Est. primary completion date August 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 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 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 Design


Related Conditions & MeSH terms


Intervention

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.

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