<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/NCT04422080</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0338</org_study_id>
    <nct_id>NCT04422080</nct_id>
  </id_info>
  <brief_title>Retrospective Observational Study of Posterior Keratometry Measured</brief_title>
  <official_title>Retrospective Observational Study of Posterior Keratometry Measured by IOLMaster 700 in Patients With Keratoconus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</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 progressive bilateral disease leading to an apical stromal thinning and an&#xD;
      irregular astigmatism by a steepening of the cornea, causing visual impairment. The causes&#xD;
      are not yet well known, but it seems to be linked to several comorbidities. Keratoconus is a&#xD;
      rare and for a long-time asymptomatic condition and its diagnosis needs meticulous screening&#xD;
      for the early stages. Detecting it as soon as possible is a goal as it could lead to earlier&#xD;
      avoiding of contributing factors such as eye rubbing and earlier treatment if needed.&#xD;
&#xD;
      The gold standard for keratoconus screening and staging is computerized videotography. It&#xD;
      gives information about anterior and posterior corneal bulging, steepening, and thinning. It&#xD;
      can be completed by anterior segment optical coherence tomography, which can show corneal&#xD;
      scarring. Since recently, some biometry devices can give some information about the posterior&#xD;
      corneal keratometry trough swept source optical coherence tomography measures. The&#xD;
      measurement of the total corneal power instead of an extrapolation lead to better precision&#xD;
      in refractive results after cataract surgery in some cases. It also helped to increase our&#xD;
      knowledge about posterior corneal astigmatism. In normal eyes, average posterior corneal&#xD;
      astigmatism is 0.37 diopters and against the rule in 91 percent of eyes. There is a&#xD;
      correlation between the magnitude of anterior and posterior astigmatism.&#xD;
&#xD;
      In keratoconus eyes, several studies have shown that there is an alignment between axes of&#xD;
      the anterior and posterior corneal astigmatism. These studies have been performed on&#xD;
      computerized videotopography devices.&#xD;
&#xD;
      The goal of this study was to confirm or deny previous observations about posterior&#xD;
      astigmatism in keratoconus eyes, and to assess if the rotation of axis between anterior and&#xD;
      posterior astigmatism measured by IOL Master 700® can be a good sign for detection of early&#xD;
      stages and fruste keratoconus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">June 3, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Posterior keratometry</measure>
    <time_frame>1 day</time_frame>
    <description>Posterior cylinder and axis measured on biometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total keratometry</measure>
    <time_frame>1 day</time_frame>
    <description>Total corneal power (cylinder and axis) measured on biometrycompleted by the patient</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Keratoconus</condition>
  <arm_group>
    <arm_group_label>Keratoconus patient</arm_group_label>
    <description>Patient with keratoconus disease diagnosed on videotopography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy patient</arm_group_label>
    <description>Patient consulting for keratoconus screening with no keratoconus on videotopography</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        included all patients having a specialized cornea consultation, in which keratoconus was&#xD;
        diagnosed or suspected from November 2018 to May 2020 in the department of Ophthalmology,&#xD;
        University Hospital Gui de Chauliac in Montpellier (France),&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Keratoconus diagnosed on videotopography&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - loss of sight due to another condition than keratoconus, corneal scarring leading to lack&#xD;
        or mistaken data, corneal graft, non-keratoconus related corneal ectasia such as post Laser&#xD;
        in Situ Keratomileusis (LASIK) ectasia or keratoglobus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arnaud : MUYL CIPOLLINA, Internship of ophthalmology</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals of Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UH Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ophthalmology</keyword>
  <keyword>Keratoconus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratoconus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04422080
org study id: RECHMPL20_0338
nct id: NCT04422080
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Keratoconus is a progressive bilateral disease leading to an apical stromal thinning and an
      irregular astigmatism by a steepening of the cornea, causing visual impairment. The causes
      are not yet well known, but it seems to be linked to several comorbidities. Keratoconus is a
      rare and for a long-time asymptomatic condition and its diagnosis needs meticulous screening
      for the early stages. Detecting it as soon as possible is a goal as it could lead to earlier
      avoiding of contributing factors such as eye rubbing and earlier treatment if needed.

      The gold standard for keratoconus screening and staging is computerized videotography. It
      gives information about anterior and posterior corneal bulging, steepening, and thinning. It
      can be completed by anterior segment optical coherence tomography, which can show corneal
      scarring. Since recently, some biometry devices can give some information about the posterior
      corneal keratometry trough swept source optical coherence tomography measures. The
      measurement of the total corneal power instead of an extrapolation lead to better precision
      in refractive results after cataract surgery in some cases. It also helped to increase our
      knowledge about posterior corneal astigmatism. In normal eyes, average posterior corneal
      astigmatism is 0.37 diopters and against the rule in 91 percent of eyes. There is a
      correlation between the magnitude of anterior and posterior astigmatism.

      In keratoconus eyes, several studies have shown that there is an alignment between axes of
      the anterior and posterior corneal astigmatism. These studies have been performed on
      computerized videotopography devices.

      The goal of this study was to confirm or deny previous observations about posterior
      astigmatism in keratoconus eyes, and to assess if the rotation of axis between anterior and
      posterior astigmatism measured by IOL Master 700® can be a good sign for detection of early
      stages and fruste keratoconus.
observational model: Cohort
time perspective: Retrospective
measure: Posterior keratometry
time frame: 1 day
description: Posterior cylinder and axis measured on biometry
measure: Total keratometry
time frame: 1 day
description: Total corneal power (cylinder and axis) measured on biometrycompleted by the patient
arm group label: Keratoconus patient
description: Patient with keratoconus disease diagnosed on videotopography
arm group label: Healthy patient
description: Patient consulting for keratoconus screening with no keratoconus on videotopography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arnaud : MUYL CIPOLLINA, Internship of ophthalmology
role: Principal Investigator
affiliation: University Hospitals of Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Keratoconus
sharing ipd: Undecided
ipd description: NC