<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/NCT03010748</url>
  </required_header>
  <id_info>
    <org_study_id>Tianjin EH-pentacam</org_study_id>
    <nct_id>NCT03010748</nct_id>
  </id_info>
  <brief_title>Multi-center Clinical Trial on Corneal Morphology Analysis in Chinese Population</brief_title>
  <official_title>Multi-center Clinical Trial on Corneal Morphology Analysis in Chinese Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Eye Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Science Center of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second People's Hospital of Yunnan Province</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan General Hospital of Guangzhou Military Command</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xinjiang Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gansu Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tianjin Eye Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Based on the corneal morphometry instrumentation Oculus Pentacam, which is commonly used&#xD;
      before and after clinical refractive surgery, we will collect the corneal morphological and&#xD;
      biologic parameters of the population under refractive surgery screening in refractive&#xD;
      surgery centers around the country, and construct corneal morphology database in different&#xD;
      living areas of Chinese people. Based on this, compared with the suspected keratoconus and&#xD;
      keratoconus population, the screening criteria and reference standards accord with the&#xD;
      characteristics of keratoconus of Chinese ethnic will be achieved.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The safety of refractive surgery has always been the focus of attention, keratoconus&#xD;
      screening is the most important part for the preoperative examination of refractive surgery.&#xD;
      Favorable tools and appropriate indicators are the premise of fast and accurate screening,&#xD;
      and the corneal morphology from various regions of China have various characteristics, the&#xD;
      use of uniform standards developed by foreign screening will always induce a lot of problems,&#xD;
      for example, the differences of cornea morphological features between European and American&#xD;
      ethnic and Chinese race, as well as the corneal morphometric indicators between various&#xD;
      regions of China, will cause varying degrees of false-positive or false-negative screening&#xD;
      results. Based on this, in order to further improve the safety of refractive surgery&#xD;
      effectively and to obtain the effective and accurate screening of suspected keratoconus&#xD;
      population, this study will be conducted to collect the corneal morphological characteristics&#xD;
      database of Chinese people from all over the country, and to develop a database of Chinese&#xD;
      ethnographic characteristics for screening keratoconus indicators and reference valuable to&#xD;
      guide clinical screening and surgical design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2015</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>corneal thickness</measure>
    <time_frame>preoperative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>corneal curvature measured by the Pentacam system</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>coma aberration measured by the Pentacam system</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>aspherical index measured by the Pentacam system</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>spherical aberration measured by the Pentacam system</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>corrected distance visual acuity</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>uncorrected distance visual acuity</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>refractive diopter</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>corneal volume measured by the Pentacam system</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>kapple angle measured by the Pentacam system</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>introcular pressure</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>corneal diameter measured by the Pentacam system</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anterior chamber depth measured by the Pentacam system</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anterior chamber angle measured by the Pentacam system</measure>
    <time_frame>preoperative</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50000</enrollment>
  <condition>Cornea</condition>
  <arm_group>
    <arm_group_label>Chinese population</arm_group_label>
    <description>Chinese population of different nation from several provinces.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Scheimpflug tomography system (Pentacam) measurement</intervention_name>
    <description>The Scheimpflug tomography system (Pentacam,Oculus GmbH, Wetzlar, Germany) is a rotating Scheimpflug camera that measures 138,000 true elevation points to compute corneal topography. Patients were asked to blink twice and then look at the fixation device. Image acquisition was a 2-second scan of 50 rotational Scheimpflug images through the corneal sighting point, the point where the ray of light from the fovea to the fixation device crossed the cornea. All measurements were performed just after a blink to minimize the effect of tear film alteration on the data. Acceptable maps had at least 10.0 mm of corneal coverage with no extrapolated data in the central 9.0 mm zone.</description>
    <arm_group_label>Chinese population</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese population of different nation from several provinces,including Jilin, Xi'an,&#xD;
        Yunnan, Wuhan,etc.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No less than 18 years old, in good health, have no active disease in the body and eye,&#xD;
             have permanent resident status and have lived in the local area for at least 5 years&#xD;
             (please mark the nation).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Eye diseases, glaucoma, ocular hypertension, glaucoma patients with normal pressure,&#xD;
             fundus lesions, ptosis and other eyelid abnormalities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan Wang, director</last_name>
    <role>Study Director</role>
    <affiliation>Tianjin Eye Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaoyu li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second People's Hospital of Yunnan Province</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yan Zhang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jilin University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jun Yang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gansu Provincial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jing Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Health Science Center of Xi'an Jiaotong University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xianglong Yi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xinjiang Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhengwei Shen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuhan General Hospital of Guangzhou Military Command</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yan Wang, director</last_name>
    <phone>+86-02227305083</phone>
    <email>wangyan7143@vip.sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lin Zhang</last_name>
    <phone>+86-02227305083</phone>
    <email>zhanglin_2015@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tianjin Eye Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Wang, director</last_name>
      <phone>+86-02227305083</phone>
      <email>wangyan7143@vip.sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S0004-27492016000400264&amp;lng=en&amp;nrm=iso&amp;tlng=en</url>
    <description>Differentiation of mild keratoconus from corneal warpage according to topographic inferior steepening based on corneal tomography data</description>
  </link>
  <link>
    <url>http://link.springer.com/article/10.1007%2Fs10792-016-0382-5</url>
    <description>Is keratoconus more severe in pediatric population?</description>
  </link>
  <reference>
    <citation>Silverman RH, Urs R, RoyChoudhury A, Archer TJ, Gobbe M, Reinstein DZ. Combined tomography and epithelial thickness mapping for diagnosis of keratoconus. Eur J Ophthalmol. 2017 Mar 10;27(2):129-134. doi: 10.5301/ejo.5000850. Epub 2016 Aug 8.</citation>
    <PMID>27515569</PMID>
  </reference>
  <reference>
    <citation>Chan TCY, Biswas S, Yu M, Jhanji V. Comparison of corneal measurements in keratoconus using swept-source optical coherence tomography and combined Placido-Scheimpflug imaging. Acta Ophthalmol. 2017 Sep;95(6):e486-e494. doi: 10.1111/aos.13298. Epub 2016 Nov 2.</citation>
    <PMID>27805316</PMID>
  </reference>
  <reference>
    <citation>Patrao LF, Canedo AL, Azevedo JL, Correa R, Ambrosio R Jr. Differentiation of mild keratoconus from corneal warpage according to topographic inferior steepening based on corneal tomography data. Arq Bras Oftalmol. 2016 Jul-Aug;79(4):264-7. doi: 10.5935/0004-2749.20160075.</citation>
    <PMID>27626155</PMID>
  </reference>
  <reference>
    <citation>Naderan M, Rajabi MT, Zarrinbakhsh P, Farjadnia M. Is keratoconus more severe in pediatric population? Int Ophthalmol. 2017 Oct;37(5):1169-1173. doi: 10.1007/s10792-016-0382-5. Epub 2016 Oct 25.</citation>
    <PMID>27783185</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>corneal morphology</keyword>
  <keyword>Chinese population</keyword>
  <keyword>corneal curvature</keyword>
  <keyword>corneal thickness</keyword>
  <keyword>higher order aberrations</keyword>
  <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/NCT03010748
org study id: Tianjin EH-pentacam
nct id: NCT03010748
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Based on the corneal morphometry instrumentation Oculus Pentacam, which is commonly used
      before and after clinical refractive surgery, we will collect the corneal morphological and
      biologic parameters of the population under refractive surgery screening in refractive
      surgery centers around the country, and construct corneal morphology database in different
      living areas of Chinese people. Based on this, compared with the suspected keratoconus and
      keratoconus population, the screening criteria and reference standards accord with the
      characteristics of keratoconus of Chinese ethnic will be achieved.
The safety of refractive surgery has always been the focus of attention, keratoconus
      screening is the most important part for the preoperative examination of refractive surgery.
      Favorable tools and appropriate indicators are the premise of fast and accurate screening,
      and the corneal morphology from various regions of China have various characteristics, the
      use of uniform standards developed by foreign screening will always induce a lot of problems,
      for example, the differences of cornea morphological features between European and American
      ethnic and Chinese race, as well as the corneal morphometric indicators between various
      regions of China, will cause varying degrees of false-positive or false-negative screening
      results. Based on this, in order to further improve the safety of refractive surgery
      effectively and to obtain the effective and accurate screening of suspected keratoconus
      population, this study will be conducted to collect the corneal morphological characteristics
      database of Chinese people from all over the country, and to develop a database of Chinese
      ethnographic characteristics for screening keratoconus indicators and reference valuable to
      guide clinical screening and surgical design.
observational model: Case-Crossover
time perspective: Cross-Sectional
measure: corneal thickness
time frame: preoperative
measure: corneal curvature measured by the Pentacam system
time frame: preoperative
measure: coma aberration measured by the Pentacam system
time frame: preoperative
measure: aspherical index measured by the Pentacam system
time frame: preoperative
measure: spherical aberration measured by the Pentacam system
time frame: preoperative
measure: corrected distance visual acuity
time frame: preoperative
measure: uncorrected distance visual acuity
time frame: preoperative
measure: refractive diopter
time frame: preoperative
measure: corneal volume measured by the Pentacam system
time frame: preoperative
measure: kapple angle measured by the Pentacam system
time frame: preoperative
measure: introcular pressure
time frame: preoperative
measure: corneal diameter measured by the Pentacam system
time frame: preoperative
measure: anterior chamber depth measured by the Pentacam system
time frame: preoperative
measure: anterior chamber angle measured by the Pentacam system
time frame: preoperative
arm group label: Chinese population
description: Chinese population of different nation from several provinces.
intervention type: Device
intervention name: Scheimpflug tomography system (Pentacam) measurement
description: The Scheimpflug tomography system (Pentacam,Oculus GmbH, Wetzlar, Germany) is a rotating Scheimpflug camera that measures 138,000 true elevation points to compute corneal topography. Patients were asked to blink twice and then look at the fixation device. Image acquisition was a 2-second scan of 50 rotational Scheimpflug images through the corneal sighting point, the point where the ray of light from the fovea to the fixation device crossed the cornea. All measurements were performed just after a blink to minimize the effect of tear film alteration on the data. Acceptable maps had at least 10.0 mm of corneal coverage with no extrapolated data in the central 9.0 mm zone.
arm group label: Chinese population
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yan Wang, director
role: Study Director
affiliation: Tianjin Eye Hospital
last name: Xiaoyu li
role: Principal Investigator
affiliation: Second People's Hospital of Yunnan Province
last name: Yan Zhang
role: Principal Investigator
affiliation: Jilin University
last name: Jun Yang
role: Principal Investigator
affiliation: Gansu Provincial Hospital
last name: Jing Li
role: Principal Investigator
affiliation: Health Science Center of Xi'an Jiaotong University
last name: Xianglong Yi
role: Principal Investigator
affiliation: Xinjiang Medical University
last name: Zhengwei Shen
role: Principal Investigator
affiliation: Wuhan General Hospital of Guangzhou Military Command
last name: Yan Wang, director
phone: +86-02227305083
email: wangyan7143@vip.sina.com
last name: Lin Zhang
phone: +86-02227305083
email: zhanglin_2015@126.com
facility: 
status: Recruiting
contact: 
country: China
url: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0004-27492016000400264&lng=en&nrm=iso&tlng=en
description: Differentiation of mild keratoconus from corneal warpage according to topographic inferior steepening based on corneal tomography data
url: http://link.springer.com/article/10.1007%2Fs10792-016-0382-5
description: Is keratoconus more severe in pediatric population?
citation: Silverman RH, Urs R, RoyChoudhury A, Archer TJ, Gobbe M, Reinstein DZ. Combined tomography and epithelial thickness mapping for diagnosis of keratoconus. Eur J Ophthalmol. 2017 Mar 10;27(2):129-134. doi: 10.5301/ejo.5000850. Epub 2016 Aug 8.
PMID: 27515569
citation: Chan TCY, Biswas S, Yu M, Jhanji V. Comparison of corneal measurements in keratoconus using swept-source optical coherence tomography and combined Placido-Scheimpflug imaging. Acta Ophthalmol. 2017 Sep;95(6):e486-e494. doi: 10.1111/aos.13298. Epub 2016 Nov 2.
PMID: 27805316
citation: Patrao LF, Canedo AL, Azevedo JL, Correa R, Ambrosio R Jr. Differentiation of mild keratoconus from corneal warpage according to topographic inferior steepening based on corneal tomography data. Arq Bras Oftalmol. 2016 Jul-Aug;79(4):264-7. doi: 10.5935/0004-2749.20160075.
PMID: 27626155
citation: Naderan M, Rajabi MT, Zarrinbakhsh P, Farjadnia M. Is keratoconus more severe in pediatric population? Int Ophthalmol. 2017 Oct;37(5):1169-1173. doi: 10.1007/s10792-016-0382-5. Epub 2016 Oct 25.
PMID: 27783185
responsible party type: Sponsor
sharing ipd: No