<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/NCT02185469</url>
  </required_header>
  <id_info>
    <org_study_id>PRECC001</org_study_id>
    <nct_id>NCT02185469</nct_id>
  </id_info>
  <brief_title>Corneal Endothelial Cell Loss After Pneumatic Retinopexy for the Repair of Primary Rhegmatogenous Retinal Detachment</brief_title>
  <official_title>Corneal Endothelial Cell Loss After Pneumatic Retinopexy for the Repair of Primary Rhegmatogenous Retinal Detachment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are multiple ways to treat retinal detachment, the aim of this study is to compare the&#xD;
      amount of corneal endothelial cell loss after pneumatic retinopexy in comparison to&#xD;
      vitrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retinal detachment is a separation of the neurosensory retina from the retinal pigment&#xD;
      epithelium. The most common form is rhegmatogenous retinal detachment, which occurs as the&#xD;
      result of a full-thickness retinal break. There are three major techniques available to&#xD;
      repair the detachment: scleral buckling, primary vitrectomy, and pneumatic retinopexy. At our&#xD;
      institution, pneumatic retinopexy is the technique most commonly employed for primary repair.&#xD;
      Pneumatic retinopexy is a minimally invasive surgery that involves injection of an&#xD;
      intravitreal gas bubble to tamponade the causative retinal tear(s) and cryotherapy or laser&#xD;
      photocoagulation to create a permanent chorioretinal adhesion.&#xD;
&#xD;
      Endothelial cells pumping function is essential to keep the cornea in a relatively dehydrated&#xD;
      state that allows optical clarity. Corneal endothelial damage has been associated with almost&#xD;
      all types of intraocular surgery. Cell loss due to vitrectomy in phakic eyes varies between&#xD;
      0.4 and 2.8%. , , , , During pars plana vitrectomy, all manipulation take place in the&#xD;
      vitreous cavity; a certain distance from the corneal endothelium. Cataract extraction by&#xD;
      phacoemulsification results in greater endothelial cell loss (4-18%), because of the greater&#xD;
      proximity to the corneal endothelium during manipulation and direct damage from the use of&#xD;
      ultrasound. To our knowledge, corneal endothelial cell loss after pneumatic retinopexy has&#xD;
      never been studied. Corneal endothelium can be damaged during pneumatic retinopexy because an&#xD;
      anterior paracentesis is performed before the gas injection. A 5/8-in 25-gauge needle is used&#xD;
      to withdraw 0.3 to 0.35 ml of aqueous fluid form the anterior chamber. The procedure is&#xD;
      invariably accompanied by a certain degree of shallowing of the anterior chamber. We&#xD;
      postulate that endothelial cell damage can result from the direct contact of the needle tip&#xD;
      with the corneal endothelium during wound creation and by inadvertent contact during&#xD;
      shallowing of the anterior chamber.&#xD;
&#xD;
      A standard method of endothelial cell analysis used worldwide is specular microscopy.&#xD;
      Specular microscopy is a non-invasive technique to access the structure and function of the&#xD;
      corneal endothelium by permitting visualization of the corneal endothelial mosaic. From the&#xD;
      areas of the cornea measured with specular microscopy, an estimate of endothelial cell&#xD;
      density can be made.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial cells count as measured by specular microscopy</measure>
    <time_frame>at 3 and 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Rhegmatogenous Retinal Detachment</condition>
  <arm_group>
    <arm_group_label>pneumatic retinopexy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>First, a 5/8-in 25-gauge needle will be used to perform an anterior chamber paracentesis, aiming to withdraw a minimum of 0.3 ml of aqueous fluid form the anterior chamber. Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity. The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml). The laser retinopexy will be performed 48 hours later with laser.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vitrectomy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Under certain circumstances, pneumatic retinopexy can't be considered as a primary treatment for rhegmatogenous retinal detachment. In these cases, the patient will be booked for urgent 25 G vitrectomy with intraoperative laser retinopexy and gas injection to treat retinal detachment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pneumatic retinopexy</intervention_name>
    <description>First, a 5/8-in 25-gauge needle will be used to perform an anterior chamber paracentesis, aiming to withdraw a minimum of 0.3 ml of aqueous fluid form the anterior chamber. Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity. The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml). The laser retinopexy will be performed 48 hours later with laser.</description>
    <arm_group_label>pneumatic retinopexy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>vitrectomy</intervention_name>
    <description>Under certain circumstances, pneumatic retinopexy can't be considered as a primary treatment for rhegmatogenous retinal detachment. In these cases, the patient will be booked for urgent 25 G vitrectomy with intraoperative laser retinopexy and gas injection to treat retinal detachment</description>
    <arm_group_label>vitrectomy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sulfur hexafluoride (SF6)</intervention_name>
    <arm_group_label>pneumatic retinopexy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>5/8-in 25-gauge needle</intervention_name>
    <arm_group_label>pneumatic retinopexy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laser</intervention_name>
    <description>intraoperative laser retinopexy</description>
    <arm_group_label>pneumatic retinopexy group</arm_group_label>
    <arm_group_label>vitrectomy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age more than 18 years old.&#xD;
&#xD;
          -  Patients with rhegmatogenous retinal detachment undergoing pneumatic retinopexy and&#xD;
             pars plana vitrectomy.&#xD;
&#xD;
          -  Patients on which specular microscopy and IOLMaster® can be performed without delaying&#xD;
             their treatment (availability of a qualified operator).&#xD;
&#xD;
          -  Decision makers able to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to attend follow-up visits.&#xD;
&#xD;
          -  History of previous intraocular surgery in surgical eye, except cataract extraction by&#xD;
             phacoemulsification.&#xD;
&#xD;
          -  Aphakia in surgical eye.&#xD;
&#xD;
          -  Presence of an anterior chamber intraocular lens in surgical eye.&#xD;
&#xD;
          -  Need for cryotherapy to treat the retinal break.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Kertes, MD, CM, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Charlene Muller, RN, PHN,CCRP</last_name>
    <phone>416-480-5091</phone>
    <email>charlene.muller@sunnybrook.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Charlene Muller, RN, PHN,CCRP</last_name>
      <phone>416-480-5091</phone>
      <email>charlene.muller@sunnybrook.ca</email>
    </contact>
    <investigator>
      <last_name>Peter Kertes, MD, CM, FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 8, 2014</last_update_submitted>
  <last_update_submitted_qc>July 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Dr. Peter Kertes</investigator_full_name>
    <investigator_title>Dr. Peter Kertes ,MD, CM, FRCSC Chief of Ophthalmology, Retina Specialist</investigator_title>
  </responsible_party>
  <keyword>Corneal Endothelial Cell Loss</keyword>
  <keyword>pneumatic retinopexy</keyword>
  <keyword>vitrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Detachment</mesh_term>
    <mesh_term>Corneal Endothelial Cell Loss</mesh_term>
    <mesh_term>Dissociative Disorders</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/NCT02185469
org study id: PRECC001
nct id: NCT02185469
lead sponsor: 
has dmc: No
There are multiple ways to treat retinal detachment, the aim of this study is to compare the
      amount of corneal endothelial cell loss after pneumatic retinopexy in comparison to
      vitrectomy.
Retinal detachment is a separation of the neurosensory retina from the retinal pigment
      epithelium. The most common form is rhegmatogenous retinal detachment, which occurs as the
      result of a full-thickness retinal break. There are three major techniques available to
      repair the detachment: scleral buckling, primary vitrectomy, and pneumatic retinopexy. At our
      institution, pneumatic retinopexy is the technique most commonly employed for primary repair.
      Pneumatic retinopexy is a minimally invasive surgery that involves injection of an
      intravitreal gas bubble to tamponade the causative retinal tear(s) and cryotherapy or laser
      photocoagulation to create a permanent chorioretinal adhesion.

      Endothelial cells pumping function is essential to keep the cornea in a relatively dehydrated
      state that allows optical clarity. Corneal endothelial damage has been associated with almost
      all types of intraocular surgery. Cell loss due to vitrectomy in phakic eyes varies between
      0.4 and 2.8%. , , , , During pars plana vitrectomy, all manipulation take place in the
      vitreous cavity; a certain distance from the corneal endothelium. Cataract extraction by
      phacoemulsification results in greater endothelial cell loss (4-18%), because of the greater
      proximity to the corneal endothelium during manipulation and direct damage from the use of
      ultrasound. To our knowledge, corneal endothelial cell loss after pneumatic retinopexy has
      never been studied. Corneal endothelium can be damaged during pneumatic retinopexy because an
      anterior paracentesis is performed before the gas injection. A 5/8-in 25-gauge needle is used
      to withdraw 0.3 to 0.35 ml of aqueous fluid form the anterior chamber. The procedure is
      invariably accompanied by a certain degree of shallowing of the anterior chamber. We
      postulate that endothelial cell damage can result from the direct contact of the needle tip
      with the corneal endothelium during wound creation and by inadvertent contact during
      shallowing of the anterior chamber.

      A standard method of endothelial cell analysis used worldwide is specular microscopy.
      Specular microscopy is a non-invasive technique to access the structure and function of the
      corneal endothelium by permitting visualization of the corneal endothelial mosaic. From the
      areas of the cornea measured with specular microscopy, an estimate of endothelial cell
      density can be made.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Endothelial cells count as measured by specular microscopy
time frame: at 3 and 6 months
arm group label: pneumatic retinopexy group
arm group type: Active Comparator
description: First, a 5/8-in 25-gauge needle will be used to perform an anterior chamber paracentesis, aiming to withdraw a minimum of 0.3 ml of aqueous fluid form the anterior chamber. Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity. The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml). The laser retinopexy will be performed 48 hours later with laser.
arm group label: vitrectomy group
arm group type: Active Comparator
description: Under certain circumstances, pneumatic retinopexy can't be considered as a primary treatment for rhegmatogenous retinal detachment. In these cases, the patient will be booked for urgent 25 G vitrectomy with intraoperative laser retinopexy and gas injection to treat retinal detachment
intervention type: Procedure
intervention name: Pneumatic retinopexy
description: First, a 5/8-in 25-gauge needle will be used to perform an anterior chamber paracentesis, aiming to withdraw a minimum of 0.3 ml of aqueous fluid form the anterior chamber. Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity. The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml). The laser retinopexy will be performed 48 hours later with laser.
arm group label: pneumatic retinopexy group
intervention type: Procedure
intervention name: vitrectomy
description: Under certain circumstances, pneumatic retinopexy can't be considered as a primary treatment for rhegmatogenous retinal detachment. In these cases, the patient will be booked for urgent 25 G vitrectomy with intraoperative laser retinopexy and gas injection to treat retinal detachment
arm group label: vitrectomy group
intervention type: Drug
intervention name: sulfur hexafluoride (SF6)
arm group label: pneumatic retinopexy group
intervention type: Device
intervention name: 5/8-in 25-gauge needle
arm group label: pneumatic retinopexy group
intervention type: Device
intervention name: laser
description: intraoperative laser retinopexy
arm group label: pneumatic retinopexy group
arm group label: vitrectomy group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Kertes, MD, CM, FRCSC
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
last name: Charlene Muller, RN, PHN,CCRP
phone: 416-480-5091
email: charlene.muller@sunnybrook.ca
facility: 
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Dr. Peter Kertes
investigator title: Dr. Peter Kertes ,MD, CM, FRCSC Chief of Ophthalmology, Retina Specialist
mesh term: Retinal Detachment
mesh term: Corneal Endothelial Cell Loss
mesh term: Dissociative Disorders