<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/NCT01726543</url>
  </required_header>
  <id_info>
    <org_study_id>BW1 151/12</org_study_id>
    <secondary_id>BW1151/12</secondary_id>
    <nct_id>NCT01726543</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy With Phacoemulsification to Treat Glaucoma and Cataract</brief_title>
  <official_title>Comparison of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Military Institute od Medicine National Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Military Institute od Medicine National Research Institute</source>
  <brief_summary>
    <textblock>
      It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep&#xD;
      Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a&#xD;
      Randomised, Prospective Study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2011</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IOP</measure>
    <time_frame>Change from Baseline at 24months</time_frame>
    <description>by Goldman tonometry&#xD;
Primary efficacy outcome-proportion of the population that achieves an IOP of &gt;5 and ≤ 21 mmHg, irrespective of glaucoma medication use.&#xD;
Complete success is defined as achieving the target IOP without use of medications.&#xD;
A qualified success is defined as achieving the target IOP with either no change in medications or a reduction in medication as compared to that used preoperatively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>number of antiglaucoma medications</measure>
    <time_frame>Change from Baseline at 24months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>visual acuity</measure>
    <time_frame>Change from Baseline at 24months</time_frame>
    <description>ETDRS chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>intraoperative complications</measure>
    <time_frame>surgery day</time_frame>
    <description>Rates for surgical complications and adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary procedures</measure>
    <time_frame>within 24 months</time_frame>
    <description>Any additional ophtalmic surgical procedures that need to be done within the time frame.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early and late complications</measure>
    <time_frame>within 24 months</time_frame>
    <description>complications and Adverse effects rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Open Angle Glaucoma</condition>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Canaloplasty and phacoemulsification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-penetrating deep sclerectomy and phacoemulsification</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Canaloplasty and phacoemulsification</intervention_name>
    <description>As soon as the two scleral flaps (deep and superficial -similar to deep sclerectomy) are dissected, the phacoemulsification is performed and a artificial lense is implanted. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and is advanced 12 clock hours within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. When the catheterisation of the canal is done, the distal tip is exposed and a 10-0 propylene suture is tied to the distal tip. Then the microcatheter is withdrawn and suture is pulled into the canal. As it appears at the other ostium of canal the microcatheter it separated from the suture. A loop is created, encircling the inner wall of Schlemm canal. Then suture loop is tightened to distend the trabecular meshwork inward, placing the tissues in tension, the locking nods are added. The superficial flap is sutured watertight to prevent bleb formation.</description>
    <arm_group_label>Canaloplasty and phacoemulsification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-penetrating deep sclerectomy and phacoemulsification</intervention_name>
    <description>A fornix-based conjunctival ﬂap is dissected superiorly, and the sclera is exposed. A 5 x 5 mm scleral ﬂap is dissected anteriorly into clear cornea using a No. 69 Beaver blade. Then the phacoemulsification procedure is performed and a artificial lense is implanted. Afterwards second deep scleral ﬂap is dissected and excised leaving only a thin layer of deep sclera over the choroid. Anteriorly, the dissection is made down to remove Schlemm's canal and juxtacanalicular trabeculum. Excision of the corneal stroma is performed more anteriorly down to Descemet's membrane. This allows aqueous humor to percolate through the thin trabecular-Descemet's membrane. The superficial scleral ﬂap is then closed with two 10-0 monofilament nylon sutures.The conjunctiva is sutured down over the limbus with one interrupted 10-0 monofilament nylon suture at each corner.</description>
    <arm_group_label>Non-penetrating deep sclerectomy and phacoemulsification</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  co-existing glaucoma and cataract&#xD;
&#xD;
          -  glaucoma types ( open angle glaucoma,pseudoexfoliation syndrome, pigmentary glaucoma)&#xD;
&#xD;
          -  eye with characteristic glaucoma changes (biomicroscopic,visual field) with IOP&#xD;
             &gt;16mmHg on medication or without, or IOP&lt;16mmHg on 2 or more medications.&#xD;
&#xD;
          -  uncontrolled IOP&#xD;
&#xD;
          -  patients not tolerating antiglaucoma medications,&#xD;
&#xD;
          -  patients with poor compliance&#xD;
&#xD;
          -  progression in visual field&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous surgical glaucoma procedure&#xD;
&#xD;
          -  previous cataract surgery&#xD;
&#xD;
          -  visual function under 0,004&#xD;
&#xD;
          -  closed angle glaucoma&#xD;
&#xD;
          -  poorly controlled diabetes mellitus&#xD;
&#xD;
          -  advanced AMD&#xD;
&#xD;
          -  active inflammatory disease&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  mental disease or emotional instability, that could&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marek Rekas, MD,PhD,Professor</last_name>
    <role>Study Director</role>
    <affiliation>Military Institute od Medicine National Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Military Institute of Medicine</name>
      <address>
        <city>Warsaw</city>
        <zip>04-141</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Byszewska, MD</last_name>
      <phone>500285890</phone>
      <phone_ext>+48</phone_ext>
      <email>ania.byszewska@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Marek Rekas, MD, PhD Associate Professor of</last_name>
      <phone>226816575</phone>
      <phone_ext>+48</phone_ext>
      <email>rekaspl@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>April 17, 2012</study_first_submitted>
  <study_first_submitted_qc>November 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 10, 2012</last_update_submitted>
  <last_update_submitted_qc>November 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Military Institute od Medicine National Research Institute</investigator_affiliation>
    <investigator_full_name>Marek Rekas</investigator_full_name>
    <investigator_title>MD, PhD Associate Professor of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>canaloplasty</keyword>
  <keyword>non-penetrating deep sclerectomy</keyword>
  <keyword>glaucoma</keyword>
  <keyword>cataract</keyword>
  <keyword>ophthalmology</keyword>
  <keyword>glaucoma surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</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/NCT01726543
org study id: BW1 151/12
secondary id: BW1151/12
nct id: NCT01726543
lead sponsor: 
It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep
      Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a
      Randomised, Prospective Study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: IOP
time frame: Change from Baseline at 24months
description: by Goldman tonometry
Primary efficacy outcome-proportion of the population that achieves an IOP of >5 and ≤ 21 mmHg, irrespective of glaucoma medication use.
Complete success is defined as achieving the target IOP without use of medications.
A qualified success is defined as achieving the target IOP with either no change in medications or a reduction in medication as compared to that used preoperatively.
measure: number of antiglaucoma medications
time frame: Change from Baseline at 24months
measure: visual acuity
time frame: Change from Baseline at 24months
description: ETDRS chart
measure: intraoperative complications
time frame: surgery day
description: Rates for surgical complications and adverse events
measure: Secondary procedures
time frame: within 24 months
description: Any additional ophtalmic surgical procedures that need to be done within the time frame.
measure: Early and late complications
time frame: within 24 months
description: complications and Adverse effects rate
arm group label: Canaloplasty and phacoemulsification
arm group type: Active Comparator
arm group label: Non-penetrating deep sclerectomy and phacoemulsification
arm group type: Active Comparator
intervention type: Procedure
intervention name: Canaloplasty and phacoemulsification
description: As soon as the two scleral flaps (deep and superficial -similar to deep sclerectomy) are dissected, the phacoemulsification is performed and a artificial lense is implanted. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and is advanced 12 clock hours within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. When the catheterisation of the canal is done, the distal tip is exposed and a 10-0 propylene suture is tied to the distal tip. Then the microcatheter is withdrawn and suture is pulled into the canal. As it appears at the other ostium of canal the microcatheter it separated from the suture. A loop is created, encircling the inner wall of Schlemm canal. Then suture loop is tightened to distend the trabecular meshwork inward, placing the tissues in tension, the locking nods are added. The superficial flap is sutured watertight to prevent bleb formation.
arm group label: Canaloplasty and phacoemulsification
intervention type: Procedure
intervention name: Non-penetrating deep sclerectomy and phacoemulsification
description: A fornix-based conjunctival ﬂap is dissected superiorly, and the sclera is exposed. A 5 x 5 mm scleral ﬂap is dissected anteriorly into clear cornea using a No. 69 Beaver blade. Then the phacoemulsification procedure is performed and a artificial lense is implanted. Afterwards second deep scleral ﬂap is dissected and excised leaving only a thin layer of deep sclera over the choroid. Anteriorly, the dissection is made down to remove Schlemm's canal and juxtacanalicular trabeculum. Excision of the corneal stroma is performed more anteriorly down to Descemet's membrane. This allows aqueous humor to percolate through the thin trabecular-Descemet's membrane. The superficial scleral ﬂap is then closed with two 10-0 monofilament nylon sutures.The conjunctiva is sutured down over the limbus with one interrupted 10-0 monofilament nylon suture at each corner.
arm group label: Non-penetrating deep sclerectomy and phacoemulsification
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Marek Rekas, MD,PhD,Professor
role: Study Director
affiliation: Military Institute od Medicine National Research Institute
facility: 
status: Recruiting
contact: 
contact backup: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Military Institute od Medicine National Research Institute
investigator full name: Marek Rekas
investigator title: MD, PhD Associate Professor of Ophthalmology
mesh term: Glaucoma
mesh term: Cataract
mesh term: Glaucoma, Open-Angle