<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/NCT01694212</url>
  </required_header>
  <id_info>
    <org_study_id>MZJ-2106</org_study_id>
    <nct_id>NCT01694212</nct_id>
  </id_info>
  <brief_title>Preoperative Topic Diclofenac as a Prevention of Postoperative Macular Edema in Patients With Diabetic Retinopathy</brief_title>
  <official_title>Effect of Perioperative Topical Diclofenac on Intraocular Inflammation After Cataract Surgery and the Incidence of Postoperative Macular Edema in Patients With Diabetic Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eye Clinic Medic Zuljan Jukic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinical Hospital Center, Split</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Zagreb</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eye Clinic Medic Zuljan Jukic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes has many negative effects on patients' general health. Among many other consequences&#xD;
      it speeds up the cataract formation and that is why diabetic patients need cataract surgery&#xD;
      very often. The known side effect of cataract surgery even in otherwise healthy patients is&#xD;
      postoperative edema of the back of the eye (what causes decrease of vision), which has&#xD;
      greater incidence especially in patients who have diabetic eye problems. The cause of that&#xD;
      might be the intraocular inflammation which was previously demonstrated to be significantly&#xD;
      more prominent in patients with untreated diabetic eye problems. Therefore we will examine if&#xD;
      the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the&#xD;
      formation of the edema of the back of the eye.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Central Macular Thickness</measure>
    <time_frame>-7, 0, 1, 7, 30, 90 days after the cataract surger</time_frame>
    <description>The central macular thickness will be measured with OCT machine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression of diabetic retinopathy</measure>
    <time_frame>-7 and 90 days after cataract surgery</time_frame>
    <description>The grade of diabetic retinopathy will be assessed on fundus photographies according to ETDRS criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-12 concentration</measure>
    <time_frame>immediately before cataract surgery</time_frame>
    <description>The IL-12 concentration will be measured in the sample of humour aqueous taken at the beginning of cataract surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Macular Edema</condition>
  <condition>Cataract</condition>
  <condition>Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>Diclofenac</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with diabetic retinopathy having preoperative treatment with diclofenac</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group having placebo treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perioperative Diclofenac eye-drops administration</intervention_name>
    <arm_group_label>Diclofenac</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of nonproliferative diabetic retinopathy&#xD;
&#xD;
          -  presence of the cataract (LOCS 2-3)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other chronic or acute eye diseases&#xD;
&#xD;
          -  hypersensitivity to any component of the diclofenac eye-drops patients on oral&#xD;
             anticoagulant therapy&#xD;
&#xD;
          -  allergy to salycilates&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ljubo Znaor, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Hospital Center, Split</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Poliklinika Medic Zuljan Jukić</name>
      <address>
        <city>Split</city>
        <zip>21000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>April 19, 2017</last_update_submitted>
  <last_update_submitted_qc>April 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Hospital Center, Split</investigator_affiliation>
    <investigator_full_name>Ljubo Znaor</investigator_full_name>
    <investigator_title>Ophthalmologist</investigator_title>
  </responsible_party>
  <keyword>Macular edema</keyword>
  <keyword>Cataract</keyword>
  <keyword>Diabetic retinopathy</keyword>
  <keyword>Anti-inflammatory agents,Non-steroidal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diclofenac</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_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/NCT01694212
org study id: MZJ-2106
nct id: NCT01694212
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Diabetes has many negative effects on patients' general health. Among many other consequences
      it speeds up the cataract formation and that is why diabetic patients need cataract surgery
      very often. The known side effect of cataract surgery even in otherwise healthy patients is
      postoperative edema of the back of the eye (what causes decrease of vision), which has
      greater incidence especially in patients who have diabetic eye problems. The cause of that
      might be the intraocular inflammation which was previously demonstrated to be significantly
      more prominent in patients with untreated diabetic eye problems. Therefore we will examine if
      the 7 day use of anti-inflammatory eye drops prior to the cataract surgery prevent the
      formation of the edema of the back of the eye.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change of Central Macular Thickness
time frame: -7, 0, 1, 7, 30, 90 days after the cataract surger
description: The central macular thickness will be measured with OCT machine.
measure: progression of diabetic retinopathy
time frame: -7 and 90 days after cataract surgery
description: The grade of diabetic retinopathy will be assessed on fundus photographies according to ETDRS criteria
measure: IL-12 concentration
time frame: immediately before cataract surgery
description: The IL-12 concentration will be measured in the sample of humour aqueous taken at the beginning of cataract surgery.
arm group label: Diclofenac
arm group type: Experimental
description: Patients with diabetic retinopathy having preoperative treatment with diclofenac
arm group label: Placebo
arm group type: Placebo Comparator
description: Control group having placebo treatment
intervention type: Drug
intervention name: Perioperative Diclofenac eye-drops administration
arm group label: Diclofenac
intervention type: Drug
intervention name: placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: No
last name: Ljubo Znaor, MD PhD
role: Principal Investigator
affiliation: Clinical Hospital Center, Split
facility: 
country: Croatia
responsible party type: Principal Investigator
investigator affiliation: Clinical Hospital Center, Split
investigator full name: Ljubo Znaor
investigator title: Ophthalmologist
mesh term: Cataract
mesh term: Macular Edema
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Edema
mesh term: Diclofenac
mesh term: Ophthalmic Solutions