<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/NCT04410861</url>
  </required_header>
  <id_info>
    <org_study_id>MoorfieldsEyeAbuDhabi</org_study_id>
    <nct_id>NCT04410861</nct_id>
  </id_info>
  <brief_title>Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy</brief_title>
  <official_title>Comparison of Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moorfields Eye Hospital Centre Abu Dhabi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Warmia and Mazury in Olsztyn</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Gdansk</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Filatov Institute of Eye Diseases and Tissue Therapy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chang Gung Memorial Hospital</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>
      Central serous retinopathy is a disease of poorly understood etiology characterized by&#xD;
      accumulation of subretinal fluid and leading to significant decrease in vision. Micropulse&#xD;
      laser therapy has been successfully used in the treatment of CSR of both acute and chronic&#xD;
      types (1). In this treatment invisible, non-damaging laser shots are delivered to the&#xD;
      affected area which are believed to lead to absorption of accumulated fluid. The mechanism of&#xD;
      fluid resorption is unclear. There are several treatment protocols in place (2, 3). Most&#xD;
      commonly reported are minimal protocol and so-called panmacular protocol. However, there is&#xD;
      no comparative study between them assessing their clinical efficacy.&#xD;
&#xD;
      The purpose of this trial is to compare treatment efficacy in central serous&#xD;
      chorioretinopathy (CSR) using two laser parameter settings. Those will include minimal and&#xD;
      panmacular protocols. Two wavelengths will be used 577nm and 810 nm for which the rest of the&#xD;
      parameters will be defined in order to produce sublethal photostimulation. Structural and&#xD;
      functional outcomes will be compared before and after treatment as well as measures such as&#xD;
      number of repeat treatments or need for rescue treatment. We aim to show which of the laser&#xD;
      arms will lead to better clinical outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design:&#xD;
&#xD;
      This is a comparative, prospective, interventional, multicenter, randomized study of&#xD;
      micropulse laser treatment of central serous chorioretinopathy with 2 treatment arms:&#xD;
&#xD;
        1. &lt; 6 months. Treatment: Minimal vs. Panmacular (randomized)&#xD;
&#xD;
        2. &gt; 6 months. Treatment: Panmacular only&#xD;
&#xD;
      Treatment arms - description of laser settings:&#xD;
&#xD;
      For &quot;Minimal / PLACE&quot; treatment (Mainster contact lens with magnification of 1.05x):&#xD;
&#xD;
      Wavelength 810nm or 577nm, Power 0.75 Watt for 810 nm or 0.15 Watt for 577 nm, Duty Cycle 5%&#xD;
      for both wavelenths, Spot size 125um for 810 nm and 100um for 577 nm, Duration 0.3 sec 0.3&#xD;
      sec for both wavelenths, Number of spots 100-120 for both wavelenths&#xD;
&#xD;
      For &quot;Panmacular&quot; treatment (Mainster lens mag 1.05x):&#xD;
&#xD;
      Wavelength 810nm or 577nm, Power 1.70 Watt for 810 nm or 0.425 Watt for 577 nm, Duty Cycle 5%&#xD;
      for both wavelenths, Spot size 50um for both wavelengths, Duration 0.3 sec 0.3 sec for both&#xD;
      wavelenths, Number of spots 400-450 for both wavelenths&#xD;
&#xD;
      All treatments will be performed following informed consent and under topical anesthesia&#xD;
      using eyedrops 3x before procedure in the treatment eye(s). Follow-up will be every 6 weeks&#xD;
      with final one in 6 months. Each follow-up visit will include visual acuity measurement,&#xD;
      intraocular pressure, slit-lamp examination, VF and OCT examinations.&#xD;
&#xD;
      Primary Endpoints:&#xD;
&#xD;
        1. Visual Acuity as measured by ETRDS chart (number of letters before and after treatment&#xD;
&#xD;
        2. Complete subretinal fluid resolution as assessed by OCT examination (microns of central&#xD;
           retinal thickness before and after treatment; presence/absence of subretinal fluid)&#xD;
&#xD;
      Secondary Endpoints:&#xD;
&#xD;
        1. Visual Field - Humphrey 10-2 protocol (dB value before and after treatment)&#xD;
&#xD;
        2. Number of treatments required for vision/structure improvement (number of laser&#xD;
           sessions)&#xD;
&#xD;
        3. Rescue rate - number of eyes requiring intravitreal injection of anti-angiogenic agents&#xD;
           or oral eplerenone&#xD;
&#xD;
      Risks: Non-response to therapy in which case alternative rescue treatments (intravitreal&#xD;
      injection or oral eplerenone) will be offered to patient.&#xD;
&#xD;
      Benefits: Patient participating in the study will receive standard of care. Participation&#xD;
      will be entirely voluntary and in case of withdrawing from the study patient will be&#xD;
      receiving alternative approved methods of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</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>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Best-Corrected Visual Acuity (BCVA)</measure>
    <time_frame>6 months</time_frame>
    <description>BCVA will be measured using ETDRS charts and number of letters will be compared before treatment and during follow-up and at the last visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resolution of Subretinal Fluid</measure>
    <time_frame>6 months</time_frame>
    <description>This outcome will be assessed by optical coherence tomography (OCT). Microns of central retinal thickness will be compared before treatment and during follow-up and at the last visit. The presence/absence of subretinal fluid will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Field Examination</measure>
    <time_frame>6 months</time_frame>
    <description>This will be assessed by Humphry VF analyzer - 10-2 protocol and dB values will be compared before treatment, during follow-up and at the last visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for Re-treatment</measure>
    <time_frame>6 months</time_frame>
    <description>The number of eyes which have nor responded to micropulse treatment and required rescue treatment either intravitreal injection of anti-angiogenic agent or oral eplerenone will be recorded and compared between laser groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Central Serous Chorioretinopathy</condition>
  <arm_group>
    <arm_group_label>Minimal Micropulse Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wavelength 810 577 Power 0.75 W 0.15 W DC 5% 5% Spot size 125um 100um Duration 0.3 sec 0.3 sec Number of spots 100-120 100-120&#xD;
.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Panmacular Micropulse Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wavelength 810 577 Power 1.7 W 0.425 W DC 5% 5% Spot size 500um 500um Duration 0.3 sec 0.3 sec Number of spots 400-450 400-450</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Micropulse laser photostimulation</intervention_name>
    <description>In this treatment invisible, non-damaging laser shots are delivered to the affected area which are believed to lead to absorption of accumulated retinal fluid. Contact lens will be used along with topical anesthesia.Following the procedure eye will be washed with balanced salt solution.</description>
    <arm_group_label>Minimal Micropulse Arm</arm_group_label>
    <arm_group_label>Panmacular Micropulse Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CSR diagnosed &lt; 6 months ago Willingness to undergo micropulse laser treatment and&#xD;
             keep follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High myopia Other significant macular disease, other treatment for CSR Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Igor Kozak, M.D., PhD</last_name>
    <phone>+9710266536161</phone>
    <email>igor.kozak@moorfields.ae</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jeffrey Luttrull, M.D.</last_name>
    <email>jkluttrull@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Moorfields Eye Hospital Centre</name>
      <address>
        <city>Abu Dhabi</city>
        <country>United Arab Emirates</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Igor Kozak, M.D., PhD</last_name>
      <phone>066536161</phone>
    </contact>
  </location>
  <location_countries>
    <country>United Arab Emirates</country>
  </location_countries>
  <reference>
    <citation>Chhablani J, Roh YJ, Jobling AI, Fletcher EL, Lek JJ, Bansal P, Guymer R, Luttrull JK. Restorative retinal laser therapy: Present state and future directions. Surv Ophthalmol. 2018 May-Jun;63(3):307-328. doi: 10.1016/j.survophthal.2017.09.008. Epub 2017 Oct 5.</citation>
    <PMID>28987614</PMID>
  </reference>
  <reference>
    <citation>Kozak I, Luttrull JK. Modern retinal laser therapy. Saudi J Ophthalmol. 2015 Apr-Jun;29(2):137-46. doi: 10.1016/j.sjopt.2014.09.001. Epub 2014 Sep 28.</citation>
    <PMID>25892934</PMID>
  </reference>
  <results_reference>
    <citation>Wood EH, Karth PA, Sanislo SR, Moshfeghi DM, Palanker DV. NONDAMAGING RETINAL LASER THERAPY FOR TREATMENT OF CENTRAL SEROUS CHORIORETINOPATHY: What is the Evidence? Retina. 2017 Jun;37(6):1021-1033. doi: 10.1097/IAE.0000000000001386.</citation>
    <PMID>27841848</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Central Serous Chorioretinopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Due to patient confidentiality we do not plan to share individual patient data</ipd_description>
  </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/NCT04410861
org study id: MoorfieldsEyeAbuDhabi
nct id: NCT04410861
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Central serous retinopathy is a disease of poorly understood etiology characterized by
      accumulation of subretinal fluid and leading to significant decrease in vision. Micropulse
      laser therapy has been successfully used in the treatment of CSR of both acute and chronic
      types (1). In this treatment invisible, non-damaging laser shots are delivered to the
      affected area which are believed to lead to absorption of accumulated fluid. The mechanism of
      fluid resorption is unclear. There are several treatment protocols in place (2, 3). Most
      commonly reported are minimal protocol and so-called panmacular protocol. However, there is
      no comparative study between them assessing their clinical efficacy.

      The purpose of this trial is to compare treatment efficacy in central serous
      chorioretinopathy (CSR) using two laser parameter settings. Those will include minimal and
      panmacular protocols. Two wavelengths will be used 577nm and 810 nm for which the rest of the
      parameters will be defined in order to produce sublethal photostimulation. Structural and
      functional outcomes will be compared before and after treatment as well as measures such as
      number of repeat treatments or need for rescue treatment. We aim to show which of the laser
      arms will lead to better clinical outcomes.
Study Design:

      This is a comparative, prospective, interventional, multicenter, randomized study of
      micropulse laser treatment of central serous chorioretinopathy with 2 treatment arms:

        1. < 6 months. Treatment: Minimal vs. Panmacular (randomized)

        2. > 6 months. Treatment: Panmacular only

      Treatment arms - description of laser settings:

      For "Minimal / PLACE" treatment (Mainster contact lens with magnification of 1.05x):

      Wavelength 810nm or 577nm, Power 0.75 Watt for 810 nm or 0.15 Watt for 577 nm, Duty Cycle 5%
      for both wavelenths, Spot size 125um for 810 nm and 100um for 577 nm, Duration 0.3 sec 0.3
      sec for both wavelenths, Number of spots 100-120 for both wavelenths

      For "Panmacular" treatment (Mainster lens mag 1.05x):

      Wavelength 810nm or 577nm, Power 1.70 Watt for 810 nm or 0.425 Watt for 577 nm, Duty Cycle 5%
      for both wavelenths, Spot size 50um for both wavelengths, Duration 0.3 sec 0.3 sec for both
      wavelenths, Number of spots 400-450 for both wavelenths

      All treatments will be performed following informed consent and under topical anesthesia
      using eyedrops 3x before procedure in the treatment eye(s). Follow-up will be every 6 weeks
      with final one in 6 months. Each follow-up visit will include visual acuity measurement,
      intraocular pressure, slit-lamp examination, VF and OCT examinations.

      Primary Endpoints:

        1. Visual Acuity as measured by ETRDS chart (number of letters before and after treatment

        2. Complete subretinal fluid resolution as assessed by OCT examination (microns of central
           retinal thickness before and after treatment; presence/absence of subretinal fluid)

      Secondary Endpoints:

        1. Visual Field - Humphrey 10-2 protocol (dB value before and after treatment)

        2. Number of treatments required for vision/structure improvement (number of laser
           sessions)

        3. Rescue rate - number of eyes requiring intravitreal injection of anti-angiogenic agents
           or oral eplerenone

      Risks: Non-response to therapy in which case alternative rescue treatments (intravitreal
      injection or oral eplerenone) will be offered to patient.

      Benefits: Patient participating in the study will receive standard of care. Participation
      will be entirely voluntary and in case of withdrawing from the study patient will be
      receiving alternative approved methods of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Change in Best-Corrected Visual Acuity (BCVA)
time frame: 6 months
description: BCVA will be measured using ETDRS charts and number of letters will be compared before treatment and during follow-up and at the last visit.
measure: Resolution of Subretinal Fluid
time frame: 6 months
description: This outcome will be assessed by optical coherence tomography (OCT). Microns of central retinal thickness will be compared before treatment and during follow-up and at the last visit. The presence/absence of subretinal fluid will be recorded.
measure: Visual Field Examination
time frame: 6 months
description: This will be assessed by Humphry VF analyzer - 10-2 protocol and dB values will be compared before treatment, during follow-up and at the last visit.
measure: Need for Re-treatment
time frame: 6 months
description: The number of eyes which have nor responded to micropulse treatment and required rescue treatment either intravitreal injection of anti-angiogenic agent or oral eplerenone will be recorded and compared between laser groups.
arm group label: Minimal Micropulse Arm
arm group type: Active Comparator
description: Wavelength 810 577 Power 0.75 W 0.15 W DC 5% 5% Spot size 125um 100um Duration 0.3 sec 0.3 sec Number of spots 100-120 100-120
.
arm group label: Panmacular Micropulse Arm
arm group type: Experimental
description: Wavelength 810 577 Power 1.7 W 0.425 W DC 5% 5% Spot size 500um 500um Duration 0.3 sec 0.3 sec Number of spots 400-450 400-450
intervention type: Procedure
intervention name: Micropulse laser photostimulation
description: In this treatment invisible, non-damaging laser shots are delivered to the affected area which are believed to lead to absorption of accumulated retinal fluid. Contact lens will be used along with topical anesthesia.Following the procedure eye will be washed with balanced salt solution.
arm group label: Minimal Micropulse Arm
arm group label: Panmacular Micropulse Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Igor Kozak, M.D., PhD
phone: +9710266536161
email: igor.kozak@moorfields.ae
last name: Jeffrey Luttrull, M.D.
email: jkluttrull@gmail.com
facility: 
status: Recruiting
contact: 
country: United Arab Emirates
citation: Chhablani J, Roh YJ, Jobling AI, Fletcher EL, Lek JJ, Bansal P, Guymer R, Luttrull JK. Restorative retinal laser therapy: Present state and future directions. Surv Ophthalmol. 2018 May-Jun;63(3):307-328. doi: 10.1016/j.survophthal.2017.09.008. Epub 2017 Oct 5.
PMID: 28987614
citation: Kozak I, Luttrull JK. Modern retinal laser therapy. Saudi J Ophthalmol. 2015 Apr-Jun;29(2):137-46. doi: 10.1016/j.sjopt.2014.09.001. Epub 2014 Sep 28.
PMID: 25892934
citation: Wood EH, Karth PA, Sanislo SR, Moshfeghi DM, Palanker DV. NONDAMAGING RETINAL LASER THERAPY FOR TREATMENT OF CENTRAL SEROUS CHORIORETINOPATHY: What is the Evidence? Retina. 2017 Jun;37(6):1021-1033. doi: 10.1097/IAE.0000000000001386.
PMID: 27841848
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: Central Serous Chorioretinopathy
sharing ipd: No
ipd description: Due to patient confidentiality we do not plan to share individual patient data