<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/NCT04505306</url>
  </required_header>
  <id_info>
    <org_study_id>Moorfields Eye Abu Dhabi</org_study_id>
    <nct_id>NCT04505306</nct_id>
  </id_info>
  <brief_title>Short-pulse Subthreshold vs Infrared Micropulse for Diabetic Macular Edema</brief_title>
  <official_title>Comparison of Short-pulse Subthreshold (532 nm) and Infrared Micropulse (810 nm) Macular Laser for Diabetic Macular Edema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moorfields Eye Hospital Centre Abu Dhabi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>King Khaled Eye Specialist Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Moorfields Eye Hospital Centre Abu Dhabi</source>
  <oversight_info>
    <has_dmc>No</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>
      When applied according to manufacturer recommendations, short-pulse system may yield more&#xD;
      temporary reduction in edema while infrared micropulse system may yield slightly better&#xD;
      functional outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: To assess both anatomic and functional outcomes between short-pulse continuous&#xD;
      wavelength and infrared micropulse lasers in the treatment of DME.&#xD;
&#xD;
      Materials and Methods: A prospective interventional study from tertiary care eye hospital -&#xD;
      King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). Patients with center-involving&#xD;
      diabetic macular edema were treated with subthreshold laser therapy. Patients in the&#xD;
      micropulse group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX&#xD;
      Corporation, Mountain View, CA, USA). Laser was applied according to manufacturer&#xD;
      recommendations for MicroPulseTM in a confluent mode (low intensity/high density) to the&#xD;
      entire area of the macular edema. Patients in the short-pulse group were treated with grid&#xD;
      pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan)&#xD;
      with EndPoint algorithm, which was either 30% or 50% of testing burn. Main outcome measures&#xD;
      included best-corrected visual acuity (BCVA) and foveal thickness at baseline and the last&#xD;
      follow-up visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Central foveal thickness</measure>
    <time_frame>6 months</time_frame>
    <description>All patients had central retinal thickness measurement using spectral-domain optical coherence tomography (SD-OCT)(Spectralis, Heidelberg Engineering, Heidelberg, Germany). The SD-OCT B-scan was based on the Spectralis macular raster consisting of 19 horizontals 6 millimeter line scans and a real-time eye tracking system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Best corrected visual acuity</measure>
    <time_frame>6 months</time_frame>
    <description>ETDRS visual acuity charts</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <arm_group>
    <arm_group_label>Subthreshold Laser 30%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the SPCW group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with 30% EndPoint algorithm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subtreshold Laser 50%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the SPCW group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with 50% EndPoint algorithm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Micropulse Laser</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the STMP group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX Corporation, Mountain View, CA, USA) at 15% duty cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Macular Laser</intervention_name>
    <description>All treatments were performed using SPCW EndPoint 30% and 50% protocols and STMP laser. Patients in the STMP group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX Corporation, Mountain View, CA, USA) at 15% duty cycle. Laser was applied in the confluent mode (low intensity/high density) to cover the entire area of the macular edema and leakage as imaged by OCT and/or fundus fluorescein angiography. Patients in the SPCW group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with EndPoint algorithm, which was either 30% or 50% of testing burn with one burn width apart. In both groups, subthreshold power was determined by titrating burn to light (barely visible) burn and switching to either micropulse mode with 15% duty cycle or 30% and 50% EndPoint value.</description>
    <arm_group_label>Micropulse Laser</arm_group_label>
    <arm_group_label>Subthreshold Laser 30%</arm_group_label>
    <arm_group_label>Subtreshold Laser 50%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  center-involving clinically significant macular edema due to diabetic retinopathy&#xD;
             (&gt;300 microns)&#xD;
&#xD;
          -  clear ocular media&#xD;
&#xD;
          -  ETDRS visual acuity &gt;29 letters (Snellen equivalent of 20/150) or better&#xD;
&#xD;
          -  treatment naïve eyes or previously treated with antiangiogenic intravitreal agent(s)&#xD;
             more than 6 months ago to allow for long wash-out period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-center involving diabetic macular edema&#xD;
&#xD;
          -  previous retinal laser or surgery&#xD;
&#xD;
          -  intravitreal steroid use&#xD;
&#xD;
          -  any condition that may be associated with a risk of macular edema such as age-related&#xD;
             macular degeneration, retinal vein occlusion, vitreomacular traction, epiretinal&#xD;
             membrane and others.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Moorfields Eye Hospital Centre</name>
      <address>
        <city>Abu Dhabi</city>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Arab Emirates</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Moorfields Eye Hospital Centre Abu Dhabi</investigator_affiliation>
    <investigator_full_name>Igor Kozak</investigator_full_name>
    <investigator_title>Consultant Vitreoretinal Surgeon/Clinical Lead</investigator_title>
  </responsible_party>
  <keyword>micropulse laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Edema</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/NCT04505306
org study id: Moorfields Eye Abu Dhabi
nct id: NCT04505306
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
When applied according to manufacturer recommendations, short-pulse system may yield more
      temporary reduction in edema while infrared micropulse system may yield slightly better
      functional outcomes.
Purpose: To assess both anatomic and functional outcomes between short-pulse continuous
      wavelength and infrared micropulse lasers in the treatment of DME.

      Materials and Methods: A prospective interventional study from tertiary care eye hospital -
      King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). Patients with center-involving
      diabetic macular edema were treated with subthreshold laser therapy. Patients in the
      micropulse group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX
      Corporation, Mountain View, CA, USA). Laser was applied according to manufacturer
      recommendations for MicroPulseTM in a confluent mode (low intensity/high density) to the
      entire area of the macular edema. Patients in the short-pulse group were treated with grid
      pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan)
      with EndPoint algorithm, which was either 30% or 50% of testing burn. Main outcome measures
      included best-corrected visual acuity (BCVA) and foveal thickness at baseline and the last
      follow-up visit.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Central foveal thickness
time frame: 6 months
description: All patients had central retinal thickness measurement using spectral-domain optical coherence tomography (SD-OCT)(Spectralis, Heidelberg Engineering, Heidelberg, Germany). The SD-OCT B-scan was based on the Spectralis macular raster consisting of 19 horizontals 6 millimeter line scans and a real-time eye tracking system.
measure: Best corrected visual acuity
time frame: 6 months
description: ETDRS visual acuity charts
arm group label: Subthreshold Laser 30%
arm group type: Active Comparator
description: Patients in the SPCW group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with 30% EndPoint algorithm.
arm group label: Subtreshold Laser 50%
arm group type: Active Comparator
description: Patients in the SPCW group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with 50% EndPoint algorithm.
arm group label: Micropulse Laser
arm group type: Active Comparator
description: Patients in the STMP group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX Corporation, Mountain View, CA, USA) at 15% duty cycle.
intervention type: Procedure
intervention name: Macular Laser
description: All treatments were performed using SPCW EndPoint 30% and 50% protocols and STMP laser. Patients in the STMP group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX Corporation, Mountain View, CA, USA) at 15% duty cycle. Laser was applied in the confluent mode (low intensity/high density) to cover the entire area of the macular edema and leakage as imaged by OCT and/or fundus fluorescein angiography. Patients in the SPCW group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with EndPoint algorithm, which was either 30% or 50% of testing burn with one burn width apart. In both groups, subthreshold power was determined by titrating burn to light (barely visible) burn and switching to either micropulse mode with 15% duty cycle or 30% and 50% EndPoint value.
arm group label: Micropulse Laser
arm group label: Subthreshold Laser 30%
arm group label: Subtreshold Laser 50%
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United Arab Emirates
responsible party type: Principal Investigator
investigator affiliation: Moorfields Eye Hospital Centre Abu Dhabi
investigator full name: Igor Kozak
investigator title: Consultant Vitreoretinal Surgeon/Clinical Lead
mesh term: Macular Edema
mesh term: Edema
sharing ipd: No