<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/NCT04436900</url>
  </required_header>
  <id_info>
    <org_study_id>IR.BMSU.REC.1396.455</org_study_id>
    <nct_id>NCT04436900</nct_id>
  </id_info>
  <brief_title>Evaluation of Macular Structural and Functional Function Following Extensive Retinal Laser Therapy in Patients With Proliferative Diabetic Retinopathy</brief_title>
  <official_title>Evaluation of Macular Structural and Functional Function Following Extensive Retinal Laser Therapy in Patients With Proliferative Diabetic Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baqiyatallah Medical Sciences University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baqiyatallah Medical Sciences University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The present study is a semi-experimental clinical trial that 20 patients (40 eyes) with PDR&#xD;
      underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron&#xD;
      with a duration of 200 ms. The variables of contrast sensitivity, macula thickness under&#xD;
      fovea , BCVA, the width of thyroid under fovea , RNFL thickness in the four areas around the&#xD;
      disc, and the quality of life questionnaire of all patients were recorded at the beginning of&#xD;
      the study.Retinal and choroid under fovea thickness and RNFL thickness were assessed in four&#xD;
      areas, one week and one month after the end of treatment, and all the variables mentioned&#xD;
      earlier were evaluated three months after PRP surgery.&#xD;
&#xD;
      This study is single group that the outcomes are compared before and after the intervention&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2018</start_date>
  <completion_date type="Actual">April 10, 2019</completion_date>
  <primary_completion_date type="Actual">February 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Life Quality</measure>
    <time_frame>up to 3 months</time_frame>
    <description>A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease Which is measured by a quality of life questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RNFL</measure>
    <time_frame>up to 30 days</time_frame>
    <description>retinal nerve fiber layer which measured by PP-OCT (optical coherence tomography)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BCVA</measure>
    <time_frame>up to 3 months</time_frame>
    <description>best corrected visual acuity which measured by SD-OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retinal thickness in the central part of Fovea</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Measured by SD-OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Choroid thickness in the central part of Fovea</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Measured by EDI-OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical examination of PDR</measure>
    <time_frame>up to 3 months</time_frame>
    <description>An eye exam performed by an ophthalmologist will determine if there is retinopathy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Contrast sensitivity</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Contrast sensitivity which measured by Melbourne edge test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Angiography with fluorescein</measure>
    <time_frame>up to 3 months</time_frame>
    <description>By injecting fluorescein into the vein and then taking an X-ray to diagnose PDR</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients (40 eyes) with PDR underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Panretinal Photocoagulation (PRP)</intervention_name>
    <description>PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes Mellitus, Type 2 with PDR&#xD;
&#xD;
          -  Having conscious satisfaction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of other eye diseases&#xD;
&#xD;
          -  Patients with a history of previous laser treatment&#xD;
&#xD;
          -  Patients with a history of injection of Anti-VGEF&#xD;
&#xD;
          -  Patients with Vitreous hemorrhage&#xD;
&#xD;
          -  Patients with Macula edema&#xD;
&#xD;
          -  Patients with myopia more than -3 diopters or hyperopiamore than +3 diopters&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mohammad Sadegh Bagheri Baghdasht</name>
      <address>
        <city>Tehran</city>
        <zip>0</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baqiyatallah Medical Sciences University</investigator_affiliation>
    <investigator_full_name>Mohammad Sadegh Bagheri Baghdasht</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT04436900
org study id: IR.BMSU.REC.1396.455
nct id: NCT04436900
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study is a semi-experimental clinical trial that 20 patients (40 eyes) with PDR
      underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron
      with a duration of 200 ms. The variables of contrast sensitivity, macula thickness under
      fovea , BCVA, the width of thyroid under fovea , RNFL thickness in the four areas around the
      disc, and the quality of life questionnaire of all patients were recorded at the beginning of
      the study.Retinal and choroid under fovea thickness and RNFL thickness were assessed in four
      areas, one week and one month after the end of treatment, and all the variables mentioned
      earlier were evaluated three months after PRP surgery.

      This study is single group that the outcomes are compared before and after the intervention
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Life Quality
time frame: up to 3 months
description: A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease Which is measured by a quality of life questionnaire
measure: RNFL
time frame: up to 30 days
description: retinal nerve fiber layer which measured by PP-OCT (optical coherence tomography)
measure: BCVA
time frame: up to 3 months
description: best corrected visual acuity which measured by SD-OCT
measure: Retinal thickness in the central part of Fovea
time frame: up to 30 days
description: Measured by SD-OCT
measure: Choroid thickness in the central part of Fovea
time frame: up to 30 days
description: Measured by EDI-OCT
measure: Physical examination of PDR
time frame: up to 3 months
description: An eye exam performed by an ophthalmologist will determine if there is retinopathy
measure: Contrast sensitivity
time frame: up to 3 months
description: Contrast sensitivity which measured by Melbourne edge test
measure: Angiography with fluorescein
time frame: up to 3 months
description: By injecting fluorescein into the vein and then taking an X-ray to diagnose PDR
arm group label: Intervention group
arm group type: Experimental
description: 20 patients (40 eyes) with PDR underwent PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms.
intervention type: Procedure
intervention name: Panretinal Photocoagulation (PRP)
description: PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms.
arm group label: Intervention group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Baqiyatallah Medical Sciences University
investigator full name: Mohammad Sadegh Bagheri Baghdasht
investigator title: Principal Investigator
mesh term: Diabetic Retinopathy
mesh term: Diabetes Mellitus, Type 2