<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/NCT02988752</url>
  </required_header>
  <id_info>
    <org_study_id>COZ001</org_study_id>
    <nct_id>NCT02988752</nct_id>
  </id_info>
  <brief_title>Comparison Between an Electronic Mobile Device and Optical Coherence Tomography to Determine Cup-to-disc Ratio</brief_title>
  <official_title>Comparison Between an Electronic Mobile Device(DEM) and Optical Coherence Tomography (OCT) to Determine Cup-to-disc Ratio (C/D) Through a Non-inferiority Trial With Masked Data Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Oftamologica Zona Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinica Oftamologica Zona Sul</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was a non-inferiority trial with masked data analysis. Individuals ranging from 18&#xD;
      to 60 years from both genders that met the pre-defined criteria were included. This study was&#xD;
      carried out in Recife at Clinica Oftalmologica Zona Sul and at Centro de Informatica-UFPE.&#xD;
      Using both equipment, 5 vertical cup-to-disc ratio (VCDR) evaluations were performed for each&#xD;
      eye of the individuals, under midriatic conditions. Evaluations were done by examiners who&#xD;
      did not know previously results obtained from other equipment. Data was collected by the main&#xD;
      researcher of this research. This study was approved by the ethics committee before it&#xD;
      started and all research members signed the TCLE agreement. The statistical test employed in&#xD;
      this study was Pearson Correlation test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Glaucoma is the second major cause of blindness in the world, lagging only behind cataract.&#xD;
      However, unlike cataract, blindness caused by glaucoma is irreversible. Early diagnosis of&#xD;
      the disease and progression monitoring is thus essential for proper treatment in order to&#xD;
      avoid irreversible blindness. The most common screening exam for glaucoma diagnosis and&#xD;
      monitoring is the eye fundus evaluation where Cup-to-Disc ratio (CDR) among other parameters&#xD;
      are assessed. This kind of evaluation is performed by ophthalmologists based on their visual&#xD;
      perception, requiring not only specific training but also some significant amount of time of&#xD;
      eye examination.Objective measurement of CDR involves high cost equipment which in turn&#xD;
      requires some specific training in order to use them. Currently, the Optical Coherence&#xD;
      Tomography is used as the gold standard for CDR measurement. An OCT exam uses a high cost and&#xD;
      complex equipment that most of the time is not affordable for low-income people. This study&#xD;
      proposes a portable electronic device that captures eye fundus images, analyzes these images,&#xD;
      performs CDR calculation and allows storing these images for further analysis. This low cost&#xD;
      and portable device was developed to be used in several health services (public or private)&#xD;
      and has low energy consumption, easing its mobility. Moreover, using this device is easy, not&#xD;
      requiring any significant learning effort from ophthalmologists. In developing countries&#xD;
      where screening programs for early diagnosis of glaucomatous neuropathy are adopted, an&#xD;
      ever-growing number of researchers are putting a significant amount of effort to develop&#xD;
      cost-benefit solutions that can reach low-income people and remote areas.&#xD;
&#xD;
      Objective: This study compared CDR measurements from the portable electronic device (PED)&#xD;
      developed by Centro de Informatica da Universidade Federal de Pernambuco to CDR measurements&#xD;
      provided by OCT.&#xD;
&#xD;
      Methods:This study was a non-inferiority trial with masked data analysis. Individuals ranging&#xD;
      from 18 to 60 years from both genders that met the pre-defined criteria were included. This&#xD;
      study was carried out in Recife at Clinica Oftalmologica Zona Sul and at Centro de&#xD;
      Informatica-UFPE. Using both equipment, 5 vertical cup-to-disc ratio (VCDR) evaluations were&#xD;
      performed for each eye of the individuals, under midriatic conditions. Evaluations were done&#xD;
      by examiners who did not know previously results obtained from other equipment. Data was&#xD;
      collected by the main researcher of this research. This study was approved by the ethics&#xD;
      committee before it started and all research members signed the TCLE agreement. The&#xD;
      statistical test employed in this study was Pearson Correlation test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective C/D Ratio measure</measure>
    <time_frame>One Year</time_frame>
    <description>To measure vertical cup to disc ratio in an objective way</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Electronic Mobile Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use an Electronic Low Cost Mobile Device To Determine C/D Ratio And Compare Results With Gold Standard Optical Coherence Tomography Results. The equipment needs mydriatic conditions and does not touch the patient's eye. The equipment uses a panoptik and a camera to access eye fundus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Optical Coherence Tomography</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device considered as gold standard to determine c/d ratio. Needs mydriatic conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electronic Mobile Device</intervention_name>
    <description>Measure C/D Ratio With An Equipment Attached To A Ophthalmoscope That Will Determine C/D Ratio Without Touching Patient's Eyes. To Perform It We Need Mydriatic Conditions.</description>
    <arm_group_label>Electronic Mobile Device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Optical Coherence Tomography</intervention_name>
    <description>Measure C/D Ratio With OCT, Considered Gold Standard Equipment</description>
    <arm_group_label>Optical Coherence Tomography</arm_group_label>
    <other_name>OCT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anyone from 18 to 60 Years old without any of the Specified Exclusion Criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Cataract&#xD;
&#xD;
          -  Eyes transparency loss&#xD;
&#xD;
          -  Best Av &lt; 0.4&#xD;
&#xD;
          -  Eye surgery in the last 12 Months&#xD;
&#xD;
          -  Use of drugs that leads to any kind of Neuropathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ANDREA SARMENTO</last_name>
    <role>Principal Investigator</role>
    <affiliation>COZ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinica Oftalmologica Zona Sul</name>
      <address>
        <city>Recife</city>
        <state>Pernambuco</state>
        <zip>51110000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>June 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinica Oftamologica Zona Sul</investigator_affiliation>
    <investigator_full_name>Andrea Gondim Leitao Sarmento</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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/NCT02988752
org study id: COZ001
nct id: NCT02988752
lead sponsor: 
has dmc: No
This study was a non-inferiority trial with masked data analysis. Individuals ranging from 18
      to 60 years from both genders that met the pre-defined criteria were included. This study was
      carried out in Recife at Clinica Oftalmologica Zona Sul and at Centro de Informatica-UFPE.
      Using both equipment, 5 vertical cup-to-disc ratio (VCDR) evaluations were performed for each
      eye of the individuals, under midriatic conditions. Evaluations were done by examiners who
      did not know previously results obtained from other equipment. Data was collected by the main
      researcher of this research. This study was approved by the ethics committee before it
      started and all research members signed the TCLE agreement. The statistical test employed in
      this study was Pearson Correlation test.
Glaucoma is the second major cause of blindness in the world, lagging only behind cataract.
      However, unlike cataract, blindness caused by glaucoma is irreversible. Early diagnosis of
      the disease and progression monitoring is thus essential for proper treatment in order to
      avoid irreversible blindness. The most common screening exam for glaucoma diagnosis and
      monitoring is the eye fundus evaluation where Cup-to-Disc ratio (CDR) among other parameters
      are assessed. This kind of evaluation is performed by ophthalmologists based on their visual
      perception, requiring not only specific training but also some significant amount of time of
      eye examination.Objective measurement of CDR involves high cost equipment which in turn
      requires some specific training in order to use them. Currently, the Optical Coherence
      Tomography is used as the gold standard for CDR measurement. An OCT exam uses a high cost and
      complex equipment that most of the time is not affordable for low-income people. This study
      proposes a portable electronic device that captures eye fundus images, analyzes these images,
      performs CDR calculation and allows storing these images for further analysis. This low cost
      and portable device was developed to be used in several health services (public or private)
      and has low energy consumption, easing its mobility. Moreover, using this device is easy, not
      requiring any significant learning effort from ophthalmologists. In developing countries
      where screening programs for early diagnosis of glaucomatous neuropathy are adopted, an
      ever-growing number of researchers are putting a significant amount of effort to develop
      cost-benefit solutions that can reach low-income people and remote areas.

      Objective: This study compared CDR measurements from the portable electronic device (PED)
      developed by Centro de Informatica da Universidade Federal de Pernambuco to CDR measurements
      provided by OCT.

      Methods:This study was a non-inferiority trial with masked data analysis. Individuals ranging
      from 18 to 60 years from both genders that met the pre-defined criteria were included. This
      study was carried out in Recife at Clinica Oftalmologica Zona Sul and at Centro de
      Informatica-UFPE. Using both equipment, 5 vertical cup-to-disc ratio (VCDR) evaluations were
      performed for each eye of the individuals, under midriatic conditions. Evaluations were done
      by examiners who did not know previously results obtained from other equipment. Data was
      collected by the main researcher of this research. This study was approved by the ethics
      committee before it started and all research members signed the TCLE agreement. The
      statistical test employed in this study was Pearson Correlation test.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Objective C/D Ratio measure
time frame: One Year
description: To measure vertical cup to disc ratio in an objective way
arm group label: Electronic Mobile Device
arm group type: Experimental
description: Use an Electronic Low Cost Mobile Device To Determine C/D Ratio And Compare Results With Gold Standard Optical Coherence Tomography Results. The equipment needs mydriatic conditions and does not touch the patient's eye. The equipment uses a panoptik and a camera to access eye fundus.
arm group label: Optical Coherence Tomography
arm group type: Active Comparator
description: Device considered as gold standard to determine c/d ratio. Needs mydriatic conditions.
intervention type: Device
intervention name: Electronic Mobile Device
description: Measure C/D Ratio With An Equipment Attached To A Ophthalmoscope That Will Determine C/D Ratio Without Touching Patient's Eyes. To Perform It We Need Mydriatic Conditions.
arm group label: Electronic Mobile Device
intervention type: Device
intervention name: Optical Coherence Tomography
description: Measure C/D Ratio With OCT, Considered Gold Standard Equipment
arm group label: Optical Coherence Tomography
other name: OCT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ANDREA SARMENTO
role: Principal Investigator
affiliation: COZ
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Clinica Oftamologica Zona Sul
investigator full name: Andrea Gondim Leitao Sarmento
investigator title: MD
mesh term: Glaucoma
sharing ipd: No