<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/NCT03288116</url>
  </required_header>
  <id_info>
    <org_study_id>2352</org_study_id>
    <nct_id>NCT03288116</nct_id>
  </id_info>
  <brief_title>Objective and Subjective Diagnostic Parameters in the Fellow Eye of Unilateral Keratoconus</brief_title>
  <official_title>Literature in Mansoura Ophthalmic Center ,Mansoura University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dar Al Shifa Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dar Al Shifa Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      patients with keratoconus in one eye and forme fruste keratoconus in the fellow eye compared&#xD;
      to normal subjects .the patients were examined by schemipflug imaging system (Pentacam)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This cross-sectional study was carried out on patients presenting keratoconus in one eye and&#xD;
      forme fruste keratoconus in the fellow eye; the patients attended the outpatient clinic of&#xD;
      Mansoura ophthalmic center between January 2014 and February 2015. This study was approved by&#xD;
      the institutional research board of the Mansoura faculty of medicine and was performed in&#xD;
      accordance with the ethical standards of the Declaration of Helsinki. All patients included&#xD;
      in the study provided informed consent.&#xD;
&#xD;
      Ocular examinations were performed on all eyes included in the study. Clinical Keratoconus&#xD;
      was diagnosed if all the following criteria were found:1)asymmetric bow tie with skewed&#xD;
      radial axis (SRAX), inferior or central steepening on the topography map, 2)mean keratometry&#xD;
      (K)&gt;47diopters or an inferior-superior (I-S) value &gt;1.4diopters according to the Rabinowitz&#xD;
      and McDonnell criteria[8],and 3)at least one clinical symptom(i.e., stromal thinning, conical&#xD;
      protrusion of corneal apex,Fleischer ring, Vogt striae or anterior stromal scar). Forme&#xD;
      fruste keratoconus was diagnosed if all the following criteria were found: 1) normal&#xD;
      topography, 2) mean K&lt;47D and I-S ≤1.4,3) normal slit lamp, and 4)keratoconus in the fellow&#xD;
      eye.&#xD;
&#xD;
      The eyes with an evident keratoconus diagnosis were included in (Group A)and the fellow eyes&#xD;
      were included in (Group B).Control cases(Group C) were selected from the normal database of&#xD;
      candidates for refractive surgery with the following:1)normal topography, 2)negative rotating&#xD;
      Scheimpflug device indices and negative topographic keratoconus classification, 3)normal slit&#xD;
      lamp examination, and 4)no history of eye disease(only one eye of each normal candidate was&#xD;
      included in the study depending on a computer-based randomizing program).&#xD;
&#xD;
      The exclusion criteria included previous ocular surgery or trauma, significant corneal&#xD;
      scarring or associated ocular pathology.&#xD;
&#xD;
      All eyes were examined by rotating Scheimpflug corneal tomography (Pentacam, Oculus&#xD;
      Optikgerate GmbH).No patients in the study wore contact lenses. During the Scheimpflug&#xD;
      corneal tomography examination, the patient was properly positioned on the chin rest and&#xD;
      forehead strap. The patient was asked to blink several times then open both eyes and stare at&#xD;
      a fixed target. After obtaining proper alignment, the automatic release mode started the&#xD;
      scan; a total of25 single Scheimpflug images were captured within 2 sec for each eye. Three&#xD;
      consecutive scans were taken of each eye by the same examiner. The average of the results of&#xD;
      three acceptable measurements was included in the study. Each eye was required to have a&#xD;
      corneal map with at least 9 mm of corneal coverage and no extrapolated data.&#xD;
&#xD;
      The Pentacam maps were analyzed. The following anterior and posterior corneal surface&#xD;
      parameters were evaluated by the Scheimpflug system: corneal dioptric power at the flattest&#xD;
      meridian in the 3 mm-central zone(K1),corneal dioptric power in the steepest meridian in the&#xD;
      3mm-central zone (K2)and mean corneal power in the 3mm-zone (mean K).&#xD;
&#xD;
      The pachymetric map was analyzed, including the central corneal thickness (CCT) at the apex&#xD;
      of the geometric center and corneal thickness at the thinnest point (CTmin).The average&#xD;
      progression index (PPI avg) was calculated as the progression value at the different rings&#xD;
      referenced to the mean curve. The minimum (PPI min) and maximum (PPI max) progression indices&#xD;
      were recorded. The Ambrósior elational thickness (ART)was calculated as follows:&#xD;
      ARTavg=CTmin/PPIavg,ARTmin = CTmin/PPImin, ARTmax =CTmin/PPImax[9].&#xD;
&#xD;
      The posterior corneal elevation maps were evaluated; a reference best fit sphere was&#xD;
      calculated at a fixed optical zone of 8 mm, and the posterior corneal elevation values&#xD;
      relative to this reference were recorded. The back difference elevation and multimetric D&#xD;
      index values were extrapolated from the difference map of the Belin/Ambrósio-enhanced ectasia&#xD;
      display of the Pentacam system.&#xD;
&#xD;
      Contrast and Glare sensitivity test:&#xD;
&#xD;
      The contract and glare tests were carried out with a Mesotest II (Oculus Optikgeräte GmbH,&#xD;
      Wetzlar, Germany), which consists of Landolt rings of different contrast levels presented in&#xD;
      front of a low-brightness background. There are 4 contrast levels, 1:23, 1:5, 1:2.7, and 1:2,&#xD;
      which represent the ratio between the light intensity of the optotypes and the background.&#xD;
      There were 8 tests, 4 without glare and 4 with glare. Test 1, with a contrast level of 1:23,&#xD;
      is the most easily recognized. For statistical purposes, each level of the contrast or glare&#xD;
      test was given a score ranging from 20% at the 1:23 level to 100% at the 1:2 level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2014</start_date>
  <completion_date type="Actual">February 5, 2015</completion_date>
  <primary_completion_date type="Actual">February 5, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>keratometric power of the corneal surface</measure>
    <time_frame>1 year</time_frame>
    <description>in diopter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>corneal thickness(pachymetry)</measure>
    <time_frame>1 year</time_frame>
    <description>in micrometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>corneal elevations</measure>
    <time_frame>1 year</time_frame>
    <description>in micrometer</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">48</enrollment>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>patient</arm_group_label>
    <description>Scheimplug imaging and contrast and sensitivity test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>early disease</arm_group_label>
    <description>Scheimplug imaging and contrast and sensitivity test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal</arm_group_label>
    <description>Scheimplug imaging and contrast and sensitivity test</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Scheimplug imaging and contrast and sensitivity test</intervention_name>
    <description>examination of the patients using the schemiplug imaging with evaluation of keratometric parametres ,pachymetric parametres ,elevation parameters.</description>
    <arm_group_label>early disease</arm_group_label>
    <arm_group_label>normal</arm_group_label>
    <arm_group_label>patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        unilateral keratoconus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with clinically evident keratoconus in one eye and apparently normal in the&#xD;
             fellow eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous ocular surgery or truama,significant corneal scarring or associatedocular&#xD;
             pathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dar Al Shifa Hospital</investigator_affiliation>
    <investigator_full_name>magda torky</investigator_full_name>
    <investigator_title>clinical professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratoconus</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/NCT03288116
org study id: 2352
nct id: NCT03288116
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
patients with keratoconus in one eye and forme fruste keratoconus in the fellow eye compared
      to normal subjects .the patients were examined by schemipflug imaging system (Pentacam)
This cross-sectional study was carried out on patients presenting keratoconus in one eye and
      forme fruste keratoconus in the fellow eye; the patients attended the outpatient clinic of
      Mansoura ophthalmic center between January 2014 and February 2015. This study was approved by
      the institutional research board of the Mansoura faculty of medicine and was performed in
      accordance with the ethical standards of the Declaration of Helsinki. All patients included
      in the study provided informed consent.

      Ocular examinations were performed on all eyes included in the study. Clinical Keratoconus
      was diagnosed if all the following criteria were found:1)asymmetric bow tie with skewed
      radial axis (SRAX), inferior or central steepening on the topography map, 2)mean keratometry
      (K)>47diopters or an inferior-superior (I-S) value >1.4diopters according to the Rabinowitz
      and McDonnell criteria[8],and 3)at least one clinical symptom(i.e., stromal thinning, conical
      protrusion of corneal apex,Fleischer ring, Vogt striae or anterior stromal scar). Forme
      fruste keratoconus was diagnosed if all the following criteria were found: 1) normal
      topography, 2) mean K<47D and I-S ≤1.4,3) normal slit lamp, and 4)keratoconus in the fellow
      eye.

      The eyes with an evident keratoconus diagnosis were included in (Group A)and the fellow eyes
      were included in (Group B).Control cases(Group C) were selected from the normal database of
      candidates for refractive surgery with the following:1)normal topography, 2)negative rotating
      Scheimpflug device indices and negative topographic keratoconus classification, 3)normal slit
      lamp examination, and 4)no history of eye disease(only one eye of each normal candidate was
      included in the study depending on a computer-based randomizing program).

      The exclusion criteria included previous ocular surgery or trauma, significant corneal
      scarring or associated ocular pathology.

      All eyes were examined by rotating Scheimpflug corneal tomography (Pentacam, Oculus
      Optikgerate GmbH).No patients in the study wore contact lenses. During the Scheimpflug
      corneal tomography examination, the patient was properly positioned on the chin rest and
      forehead strap. The patient was asked to blink several times then open both eyes and stare at
      a fixed target. After obtaining proper alignment, the automatic release mode started the
      scan; a total of25 single Scheimpflug images were captured within 2 sec for each eye. Three
      consecutive scans were taken of each eye by the same examiner. The average of the results of
      three acceptable measurements was included in the study. Each eye was required to have a
      corneal map with at least 9 mm of corneal coverage and no extrapolated data.

      The Pentacam maps were analyzed. The following anterior and posterior corneal surface
      parameters were evaluated by the Scheimpflug system: corneal dioptric power at the flattest
      meridian in the 3 mm-central zone(K1),corneal dioptric power in the steepest meridian in the
      3mm-central zone (K2)and mean corneal power in the 3mm-zone (mean K).

      The pachymetric map was analyzed, including the central corneal thickness (CCT) at the apex
      of the geometric center and corneal thickness at the thinnest point (CTmin).The average
      progression index (PPI avg) was calculated as the progression value at the different rings
      referenced to the mean curve. The minimum (PPI min) and maximum (PPI max) progression indices
      were recorded. The Ambrósior elational thickness (ART)was calculated as follows:
      ARTavg=CTmin/PPIavg,ARTmin = CTmin/PPImin, ARTmax =CTmin/PPImax[9].

      The posterior corneal elevation maps were evaluated; a reference best fit sphere was
      calculated at a fixed optical zone of 8 mm, and the posterior corneal elevation values
      relative to this reference were recorded. The back difference elevation and multimetric D
      index values were extrapolated from the difference map of the Belin/Ambrósio-enhanced ectasia
      display of the Pentacam system.

      Contrast and Glare sensitivity test:

      The contract and glare tests were carried out with a Mesotest II (Oculus Optikgeräte GmbH,
      Wetzlar, Germany), which consists of Landolt rings of different contrast levels presented in
      front of a low-brightness background. There are 4 contrast levels, 1:23, 1:5, 1:2.7, and 1:2,
      which represent the ratio between the light intensity of the optotypes and the background.
      There were 8 tests, 4 without glare and 4 with glare. Test 1, with a contrast level of 1:23,
      is the most easily recognized. For statistical purposes, each level of the contrast or glare
      test was given a score ranging from 20% at the 1:23 level to 100% at the 1:2 level.
observational model: Case-Control
time perspective: Prospective
measure: keratometric power of the corneal surface
time frame: 1 year
description: in diopter
measure: corneal thickness(pachymetry)
time frame: 1 year
description: in micrometer
measure: corneal elevations
time frame: 1 year
description: in micrometer
arm group label: patient
description: Scheimplug imaging and contrast and sensitivity test
arm group label: early disease
description: Scheimplug imaging and contrast and sensitivity test
arm group label: normal
description: Scheimplug imaging and contrast and sensitivity test
intervention type: Diagnostic Test
intervention name: Scheimplug imaging and contrast and sensitivity test
description: examination of the patients using the schemiplug imaging with evaluation of keratometric parametres ,pachymetric parametres ,elevation parameters.
arm group label: early disease
arm group label: normal
arm group label: patient
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Dar Al Shifa Hospital
investigator full name: magda torky
investigator title: clinical professor
mesh term: Keratoconus
sharing ipd: No