<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04497207</url>
  </required_header>
  <id_info>
    <org_study_id>17300437</org_study_id>
    <nct_id>NCT04497207</nct_id>
  </id_info>
  <brief_title>Deep Learning for Classification of Scheimpflug Corneal Tomography Images</brief_title>
  <official_title>Classification of Color-Coded Scheimpflug Camera Corneal Tomography Images Using Deep Learning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Keratoconus is a common disorder. An early diagnosis influences the disease prognosis in the&#xD;
      affected patients and prevents postoperative complications in patients with keratoconus&#xD;
      considering refractive surgery. Machine learning approaches have been widely used for image&#xD;
      classification. Here, we will assess the ability of deep learning to enable high-performance&#xD;
      image classification of the color-coded corneal maps obtained by Scheimpflug camera in&#xD;
      patients with keratoconus, subclinical keratoconus, and normal individuals.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Actual">August 25, 2020</completion_date>
  <primary_completion_date type="Actual">August 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Croppedm denoised, and resized to obtain four separate image stacks of 256×256 pixels</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1669</enrollment>
  <condition>Eye Diseases</condition>
  <arm_group>
    <arm_group_label>Keratoconus</arm_group_label>
    <description>Those with a clinical diagnosis of keratoconus such as:&#xD;
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 &gt;47.0D, inferior- superior(I-S) asymmetry measured to be &gt; 1.4 D or angling of the hemimeridians in an asymmetric or broken bowtie pattern with skewing of the steepest radial axis (SRAX) 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subclinical keratoconus</arm_group_label>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Scheimpflug Camera Corneal Tomography</intervention_name>
    <description>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.</description>
    <arm_group_label>Keratoconus</arm_group_label>
    <arm_group_label>Normal</arm_group_label>
    <arm_group_label>Subclinical keratoconus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with keratoconus, subclinical keratoconus &amp; normal individuals from refractive&#xD;
        surgery candidates.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Keratoconus group:&#xD;
&#xD;
          -  Presence of a central protrusion of the cornea with Fleischer ring, Vogt striae, or&#xD;
             both by slitlamp examination.&#xD;
&#xD;
          -  irregular cornea determined by distorted keratometry mires and distortion of&#xD;
             retinoscopic red reflex or both in addition to the following topographic findings as&#xD;
             summarized by Pińero and colleagues :&#xD;
&#xD;
          -  focal steepening located in a zone of protrusion surrounded by concentrically&#xD;
             decreasing power zones&#xD;
&#xD;
          -  focal areas with diopteric (D) values &gt;47.0D&#xD;
&#xD;
          -  inferior- superior(I-S) asymmetry measured to be &gt; 1.4 D&#xD;
&#xD;
          -  Angling of the hemimeridians in an asymmetric or broken bowtie pattern with skewing of&#xD;
             the steepest radial axis(SRAX) .&#xD;
&#xD;
        Suspicious group:&#xD;
&#xD;
        • Defined as subtle corneal tomographic changes as the aforementioned keratoconus&#xD;
        abnormalities in the absence of slit- lamp or visual acuity changes typical of keratoconus&#xD;
        (forme fruste keratoconus).&#xD;
&#xD;
        Normal group:&#xD;
&#xD;
          -  Refractive surgery candidates&#xD;
&#xD;
          -  Refractive error of less than 8.0 D sphere&#xD;
&#xD;
          -  Less than 3.0 D of astigmatism&#xD;
&#xD;
          -  without clinical, topographic or tomographic signs of keratoconus or suspect&#xD;
             keratoconus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic disease&#xD;
&#xD;
          -  Other corneal disease such as pellucid marginal degeneration&#xD;
&#xD;
          -  History of trauma&#xD;
&#xD;
          -  Corneal surgery such as corneal cross- linking for progressive keratoconus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Khaled Abdelazeem</investigator_full_name>
    <investigator_title>Associate professor of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>Keratoconus</keyword>
  <keyword>Deep learning</keyword>
  <keyword>Scheimpflug camera</keyword>
  <keyword>Corneal tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eye Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04497207
org study id: 17300437
nct id: NCT04497207
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Other
time perspective: Retrospective
measure: Croppedm denoised, and resized to obtain four separate image stacks of 256×256 pixels
time frame: 2 days
arm group label: Keratoconus
description: 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.
arm group label: Subclinical keratoconus
description: 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).
arm group label: Normal
description: 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.
intervention type: Other
intervention name: Scheimpflug Camera Corneal Tomography
description: 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 group label: Keratoconus
arm group label: Normal
arm group label: Subclinical keratoconus
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Khaled Abdelazeem
investigator title: Associate professor of Ophthalmology
mesh term: Eye Diseases
sharing ipd: No