<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/NCT02217306</url>
  </required_header>
  <id_info>
    <org_study_id>HJM2295/14R</org_study_id>
    <nct_id>NCT02217306</nct_id>
  </id_info>
  <brief_title>Contrast Sensitivity and Diabetic Macular Edema</brief_title>
  <official_title>Contrast Sensitivity and Diabetic Macular Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Juarez de Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Juarez de Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be&#xD;
      modified by different pathologies or by age. The purpose of this study is to identify the&#xD;
      changes that could be in relationship with the course of diabetic retinopathy comparing with&#xD;
      diabetic patient without retinopathy and in patients with diabetic macular edema so if it is&#xD;
      a difference, research for therapeutic strategies to improve it in this patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Contrast sensitivity is defined as a subjective measurement, it is the ability to separate&#xD;
      the image between figure and background, taking into account the minimum amount of light&#xD;
      required; it is evaluated by the contrast threshold, which is the smallest amount of contrast&#xD;
      needed to be able to see a target and solve their characteristics, would be his reciprocal&#xD;
      value. Medina et al. curve reported in healthy Mexicans SC 5 to 80, where &gt; 51 years have&#xD;
      decreased compared to contrast sensitivity studies international; further that contrast&#xD;
      sensitivity in older groups of 41 years is decreased high frequency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Contrast Sensitivity</measure>
    <time_frame>up to 8 months</time_frame>
    <description>Diabetic patients who are attended at Ophthalmology service in a general hospital undergo to contrast sensitivity test evaluating all frequency by software with 5 spacial frequency (1.5, 3, 6, 12 and 18 cycle grade, Stereoptical Co 1996) in the Visual Basic program.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">132</enrollment>
  <condition>DIABETES MELLITUS</condition>
  <condition>DIABETIC RETINOPATHY</condition>
  <condition>MACULAR EDEMA</condition>
  <arm_group>
    <arm_group_label>Contrast Sensitivity</arm_group_label>
    <description>Determine changes in contrast sensitivity frequences and visual function (visual acuity) after one month of treatment photocoagulation in macular edema</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Diabetic patients attended at Ophthalmology service in a general hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DIABETIC PATIENTS&#xD;
&#xD;
          -  40-60 YEARS OLD&#xD;
&#xD;
          -  ANY GENDER&#xD;
&#xD;
          -  VISUAL ACUITY &gt;0.25 IN DECIMAL EQUIVALENT,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PATIENTS WITH CATARACTS OR OTHER MACULOPATHY&#xD;
&#xD;
          -  PATIENTS WITH CONTACT LENSES&#xD;
&#xD;
          -  PATIENTS WITH REFRACTIVE ERROR &gt;6.00DP&#xD;
&#xD;
          -  PATIENTS WITH PREVIOUS OCULAR SURGERY&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>DULCE MI RAZO BLANCO HERNANDEZ, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Juarez de Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>SURISADAI SERAFIN SOLIS, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>INSTITUTO POLITECNICO NACIONAL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>LOURDES CA ORTEGA LUNA, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>INSTITUTO POLITECNICO NACIONAL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>VIRGILIO LIMA GOMEZ, MD, MSc</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Juarez de Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Juarez de Mexico</name>
      <address>
        <city>Mexico City</city>
        <zip>07760</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Juarez de Mexico</investigator_affiliation>
    <investigator_full_name>Dulce Milagros Razo Blanco Hernández</investigator_full_name>
    <investigator_title>MEDICAL RESEARCHER</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <!-- 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/NCT02217306
org study id: HJM2295/14R
nct id: NCT02217306
lead sponsor: 
has dmc: No
Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be
      modified by different pathologies or by age. The purpose of this study is to identify the
      changes that could be in relationship with the course of diabetic retinopathy comparing with
      diabetic patient without retinopathy and in patients with diabetic macular edema so if it is
      a difference, research for therapeutic strategies to improve it in this patients.
Contrast sensitivity is defined as a subjective measurement, it is the ability to separate
      the image between figure and background, taking into account the minimum amount of light
      required; it is evaluated by the contrast threshold, which is the smallest amount of contrast
      needed to be able to see a target and solve their characteristics, would be his reciprocal
      value. Medina et al. curve reported in healthy Mexicans SC 5 to 80, where > 51 years have
      decreased compared to contrast sensitivity studies international; further that contrast
      sensitivity in older groups of 41 years is decreased high frequency.
observational model: Case-Control
time perspective: Prospective
measure: Contrast Sensitivity
time frame: up to 8 months
description: Diabetic patients who are attended at Ophthalmology service in a general hospital undergo to contrast sensitivity test evaluating all frequency by software with 5 spacial frequency (1.5, 3, 6, 12 and 18 cycle grade, Stereoptical Co 1996) in the Visual Basic program.
arm group label: Contrast Sensitivity
description: Determine changes in contrast sensitivity frequences and visual function (visual acuity) after one month of treatment photocoagulation in macular edema
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: DULCE MI RAZO BLANCO HERNANDEZ, MD
role: Principal Investigator
affiliation: Hospital Juarez de Mexico
last name: SURISADAI SERAFIN SOLIS, MSc
role: Study Chair
affiliation: INSTITUTO POLITECNICO NACIONAL
last name: LOURDES CA ORTEGA LUNA, MSc
role: Study Chair
affiliation: INSTITUTO POLITECNICO NACIONAL
last name: VIRGILIO LIMA GOMEZ, MD, MSc
role: Study Director
affiliation: Hospital Juarez de Mexico
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Hospital Juarez de Mexico
investigator full name: Dulce Milagros Razo Blanco Hernández
investigator title: MEDICAL RESEARCHER
mesh term: Macular Edema
mesh term: Diabetic Retinopathy
mesh term: Edema