<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/NCT04418986</url>
  </required_header>
  <id_info>
    <org_study_id>AR200105</org_study_id>
    <nct_id>NCT04418986</nct_id>
  </id_info>
  <brief_title>Incisional Correction of Corneal Astigmatism During Phacoemulsification</brief_title>
  <official_title>Incisional Correction of Corneal Astigmatism During Phacoemulsification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Al-Rasheed University College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baghdad Medical City</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Al-Rasheed University College</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>
      Today, cataract surgery is regarded as refractive surgery, mainly aiming emmetropia, and this&#xD;
      makes eliminating corneal astigmatism is critical. Corneal astigmatism of more than 1 diopter&#xD;
      has been reported in up to 45% of the cataract surgery candidates.&#xD;
&#xD;
      It is possible to reduce pre-existing corneal astigmatism by creating a clear corneal&#xD;
      incision at the steep meridian of the cornea, however; creating a small incision can correct&#xD;
      the only astigmatism up to 1 Diopter, and sometimes this method may not be easy to perform&#xD;
      due to the location of steep meridian like the difficulty while creating a superonasal or&#xD;
      inferonasal incision at the left eye. This approach is usually sufficient for correcting&#xD;
      astigmatism less than 1 D in most eyes. An opposite side clear corneal incision (OCCI) could&#xD;
      enhance the flattening effect on the cornea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>A randomized, parallel two-arm interventional study, the patients were divided into a 1:1 ratio, the study included eyes with visually significant cataract and preoperative corneal regular astigmatism between 0.75 and 2 Diopters undergoing phacoemulsification surgery. They were divided into two groups: controls underwent phacoemulsification with on-axis incision (CCI Group), and patients underwent phacoemulsification with opposite clear corneal incisions (OCCI Group).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean astigmatic correction</measure>
    <time_frame>After 1 month of surgery</time_frame>
    <description>Astigmatic correction change after the correction surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean surgically induced astigmatism</measure>
    <time_frame>After 1 month of surgery</time_frame>
    <description>Mean surgically induced astigmatism, measured by a vector-corrected method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in visual acuity</measure>
    <time_frame>After 1 month of surgery</time_frame>
    <description>Uncorrected visual acuity and best corrected visual acuity after the surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>Control (CCI Group)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The Participants will undergo phacoemulsification with on-axis incision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study (OCCI Group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Participants will undergo phacoemulsification with opposite clear corneal incisions</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>opposite clear corneal incisions (OCCI)</intervention_name>
    <description>Coaxial small incision cataract surgery was performed for all cases using a 2.8 mm keratome placed at steep meridian and 1-mm paracentesis was made 90 degrees apart with a 20-gauge microvitrectomy blade. Surgery was performed with a 30-degree, 0.9-caliper phacoemulsification tip (microtip) with a divide and conquer technique.&#xD;
In the OCCI group, a single penetrating incision was created with 2.8 mm keratome in the clear cornea, 1.5 mm anterior to limbal blood vessels, centered over the steep meridian and opposite the phacoemulsification incision.</description>
    <arm_group_label>Control (CCI Group)</arm_group_label>
    <arm_group_label>Study (OCCI Group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clear cornea&#xD;
&#xD;
          -  No history of previous ocular surgery&#xD;
&#xD;
          -  Central corneal thickness (CCT) &lt;640&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Irregular corneal astigmatism or lenticular astigmatism&#xD;
&#xD;
          -  Corneal opacities or pathology like Fuch's endothelial dystrophy&#xD;
&#xD;
          -  Previous ocular surgeries like glaucoma surgery or PKP or pterygium excision&#xD;
&#xD;
          -  Posterior segment diseases and pathology&#xD;
&#xD;
          -  Complicated phacoemulsification&#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>Ghazi al-Hariri Surgical Specialties Hospital</name>
      <address>
        <city>Baghdad</city>
        <state>Bab-Almuadham</state>
        <zip>12221</zip>
        <country>Iraq</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iraq</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Astigmatism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </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/NCT04418986
org study id: AR200105
nct id: NCT04418986
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Today, cataract surgery is regarded as refractive surgery, mainly aiming emmetropia, and this
      makes eliminating corneal astigmatism is critical. Corneal astigmatism of more than 1 diopter
      has been reported in up to 45% of the cataract surgery candidates.

      It is possible to reduce pre-existing corneal astigmatism by creating a clear corneal
      incision at the steep meridian of the cornea, however; creating a small incision can correct
      the only astigmatism up to 1 Diopter, and sometimes this method may not be easy to perform
      due to the location of steep meridian like the difficulty while creating a superonasal or
      inferonasal incision at the left eye. This approach is usually sufficient for correcting
      astigmatism less than 1 D in most eyes. An opposite side clear corneal incision (OCCI) could
      enhance the flattening effect on the cornea.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized, parallel two-arm interventional study, the patients were divided into a 1:1 ratio, the study included eyes with visually significant cataract and preoperative corneal regular astigmatism between 0.75 and 2 Diopters undergoing phacoemulsification surgery. They were divided into two groups: controls underwent phacoemulsification with on-axis incision (CCI Group), and patients underwent phacoemulsification with opposite clear corneal incisions (OCCI Group).
primary purpose: Treatment
masking: None (Open Label)
measure: Mean astigmatic correction
time frame: After 1 month of surgery
description: Astigmatic correction change after the correction surgery
measure: Mean surgically induced astigmatism
time frame: After 1 month of surgery
description: Mean surgically induced astigmatism, measured by a vector-corrected method
measure: Change in visual acuity
time frame: After 1 month of surgery
description: Uncorrected visual acuity and best corrected visual acuity after the surgery
arm group label: Control (CCI Group)
arm group type: Sham Comparator
description: The Participants will undergo phacoemulsification with on-axis incision
arm group label: Study (OCCI Group)
arm group type: Active Comparator
description: The Participants will undergo phacoemulsification with opposite clear corneal incisions
intervention type: Procedure
intervention name: opposite clear corneal incisions (OCCI)
description: Coaxial small incision cataract surgery was performed for all cases using a 2.8 mm keratome placed at steep meridian and 1-mm paracentesis was made 90 degrees apart with a 20-gauge microvitrectomy blade. Surgery was performed with a 30-degree, 0.9-caliper phacoemulsification tip (microtip) with a divide and conquer technique.
In the OCCI group, a single penetrating incision was created with 2.8 mm keratome in the clear cornea, 1.5 mm anterior to limbal blood vessels, centered over the steep meridian and opposite the phacoemulsification incision.
arm group label: Control (CCI Group)
arm group label: Study (OCCI Group)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Iraq
responsible party type: Sponsor
mesh term: Astigmatism
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code