<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/NCT03782051</url>
  </required_header>
  <id_info>
    <org_study_id>1102108</org_study_id>
    <nct_id>NCT03782051</nct_id>
  </id_info>
  <brief_title>Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma</brief_title>
  <acronym>Visco-ologen</acronym>
  <official_title>Combined Phacoemulsification and Viscocanalostomy With Ologen Implant Versus Combined Phacoemulsification and Viscocanalostomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</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>
      This prospective, interventional, randomized clinical study was done at Alpha Vision Center,&#xD;
      Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive&#xD;
      either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with Ologen®&#xD;
      implant (OloPhacovisco group) . Follow-up period was 2 years. Nd:YAG laser goniopuncture was&#xD;
      done in cases where the intraocular pressure (IOP) was elevated above 21 mmHg after&#xD;
      discontinuation of corticosteroid eye drops at any follow-up visit.&#xD;
&#xD;
      Our hypothesis is that using Ologen® implant as a spacer in the subscleral reservoir in&#xD;
      phaco-viscocanalostomy reduces fibrosis and increase the success rate of this operation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: To study the efficacy of the biodegradable collagen implant Ologen® as an&#xD;
      adjuvant in phaco-viscocanalostomy in patients with coexisting cataract and primary open&#xD;
      angle glaucoma.&#xD;
&#xD;
      Methods: This prospective, interventional, randomized clinical study was done at Alpha Vision&#xD;
      Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to&#xD;
      receive either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with&#xD;
      Ologen® implant (OloPhacovisco group). Follow-up period was 2 years. Nd:YAG laser&#xD;
      goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21&#xD;
      mmHg after discontinuation of corticosteroid eye drops at any follow-up visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2013</start_date>
  <completion_date type="Actual">January 14, 2018</completion_date>
  <primary_completion_date type="Actual">January 14, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the intraocular pressure</measure>
    <time_frame>2 years</time_frame>
    <description>measured by mmHg using Goldman applanatin tonometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>surgical complications</measure>
    <time_frame>2 years</time_frame>
    <description>number of surgical complications encountered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the use and results of Nd:YAG laser goniopuncture</measure>
    <time_frame>2 years</time_frame>
    <description>number of cases needed goniopuncture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>visual acuity results</measure>
    <time_frame>2 years</time_frame>
    <description>visual acuity measured by decimal system</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Primary Open-angle Glaucoma</condition>
  <arm_group>
    <arm_group_label>Phacovisco group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>group had combined phacoemulsification and viscocanalostomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OloPhacovisco group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>group had combined phacoemulsification and viscocanalostomy and Ologen</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>combined phacoemulsification and viscocanalostomy</intervention_name>
    <description>phacoemulsification with viscocanalostomy</description>
    <arm_group_label>Phacovisco group</arm_group_label>
    <other_name>phaco-visco-canalostomy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>combined phacoemulsification and viscocanalostomy and ologen</intervention_name>
    <description>phacoemulsification with viscocanalostomy with ologen</description>
    <arm_group_label>OloPhacovisco group</arm_group_label>
    <other_name>phaco-visco-canalostomy with ologen implant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the presence of significant cataract interfering with vision (visual acuity ≤ 0.5) in&#xD;
             the presence POAG.&#xD;
&#xD;
          -  if cataract was associated with uncontrolled glaucoma, (IOP &gt; 21 mmHg despite&#xD;
             maximally tolerated medical therapy)&#xD;
&#xD;
          -  if the IOP was ≤ 21 mmHg with use of at least two antiglaucoma drugs with medication&#xD;
             intolerance&#xD;
&#xD;
          -  poor patient compliance&#xD;
&#xD;
          -  patients could not attend medical supervision&#xD;
&#xD;
          -  patients had visual field deterioration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  closed-angle glaucoma&#xD;
&#xD;
          -  other types of open angle glaucoma (OAG), e.g. pigmentary glaucoma, inflammatory&#xD;
             glaucoma or neovascular glaucoma,&#xD;
&#xD;
          -  previous ocular trauma or surgery&#xD;
&#xD;
          -  lens subluxation&#xD;
&#xD;
          -  any eye diseases affecting the vision, e.g. anterior uveitis&#xD;
&#xD;
          -  if there was a large perforation of the Descemet's membrane with iris prolapse during&#xD;
             surgery (cases with microperforation, which is defined as small perforation with no&#xD;
             associated iris prolapse, occurring during surgery were not excluded) intraoperative&#xD;
             complications that might affect the IOP, e.g. vitreous loss.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed AM Gad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zagazig University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alpha vision center</name>
      <address>
        <city>Zagazig</city>
        <state>Al Sharkeya</state>
        <zip>44511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Cillino S, Di Pace F, Cillino G, Casuccio A. Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial. Eye (Lond). 2011 Dec;25(12):1598-606. doi: 10.1038/eye.2011.219. Epub 2011 Sep 16.</citation>
    <PMID>21921953</PMID>
  </reference>
  <reference>
    <citation>Narayanaswamy A, Perera SA, Htoon HM, Hoh ST, Seah SK, Wong TT, Aung T. Efficacy and safety of collagen matrix implants in phacotrabeculectomy and comparison with mitomycin C augmented phacotrabeculectomy at 1 year. Clin Exp Ophthalmol. 2013 Aug;41(6):552-60. doi: 10.1111/ceo.12058.</citation>
    <PMID>23279607</PMID>
  </reference>
  <reference>
    <citation>Johnson MS, Sarkisian SR Jr. Using a collagen matrix implant (Ologen) versus mitomycin-C as a wound healing modulator in trabeculectomy with the Ex-PRESS mini glaucoma device: a 12-month retrospective review. J Glaucoma. 2014 Dec;23(9):649-52. doi: 10.1097/IJG.0000000000000018.</citation>
    <PMID>24240882</PMID>
  </reference>
  <reference>
    <citation>Hondur A, Onol M, Hasanreisoglu B. Nonpenetrating glaucoma surgery: meta-analysis of recent results. J Glaucoma. 2008 Mar;17(2):139-46. doi: 10.1097/IJG.0b013e31814b98f7.</citation>
    <PMID>18344761</PMID>
  </reference>
  <reference>
    <citation>Shaarawy T, Mermoud A. Deep sclerectomy in one eye vs deep sclerectomy with collagen implant in the contralateral eye of the same patient: long-term follow-up. Eye (Lond). 2005 Mar;19(3):298-302. doi: 10.1038/sj.eye.6701469.</citation>
    <PMID>15258610</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Ahmed moamen</investigator_full_name>
    <investigator_title>princibal investigator, lecturer of ophthalmology</investigator_title>
  </responsible_party>
  <keyword>Viscocanalostomy</keyword>
  <keyword>Ologen</keyword>
  <keyword>glaucoma</keyword>
  <keyword>phacoemulsification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03782051/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03782051
org study id: 1102108
nct id: NCT03782051
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective, interventional, randomized clinical study was done at Alpha Vision Center,
      Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive
      either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with Ologen®
      implant (OloPhacovisco group) . Follow-up period was 2 years. Nd:YAG laser goniopuncture was
      done in cases where the intraocular pressure (IOP) was elevated above 21 mmHg after
      discontinuation of corticosteroid eye drops at any follow-up visit.

      Our hypothesis is that using Ologen® implant as a spacer in the subscleral reservoir in
      phaco-viscocanalostomy reduces fibrosis and increase the success rate of this operation
Background: To study the efficacy of the biodegradable collagen implant Ologen® as an
      adjuvant in phaco-viscocanalostomy in patients with coexisting cataract and primary open
      angle glaucoma.

      Methods: This prospective, interventional, randomized clinical study was done at Alpha Vision
      Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to
      receive either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with
      Ologen® implant (OloPhacovisco group). Follow-up period was 2 years. Nd:YAG laser
      goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21
      mmHg after discontinuation of corticosteroid eye drops at any follow-up visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the intraocular pressure
time frame: 2 years
description: measured by mmHg using Goldman applanatin tonometry
measure: surgical complications
time frame: 2 years
description: number of surgical complications encountered
measure: the use and results of Nd:YAG laser goniopuncture
time frame: 2 years
description: number of cases needed goniopuncture
measure: visual acuity results
time frame: 2 years
description: visual acuity measured by decimal system
arm group label: Phacovisco group
arm group type: Active Comparator
description: group had combined phacoemulsification and viscocanalostomy
arm group label: OloPhacovisco group
arm group type: Active Comparator
description: group had combined phacoemulsification and viscocanalostomy and Ologen
intervention type: Procedure
intervention name: combined phacoemulsification and viscocanalostomy
description: phacoemulsification with viscocanalostomy
arm group label: Phacovisco group
other name: phaco-visco-canalostomy
intervention type: Procedure
intervention name: combined phacoemulsification and viscocanalostomy and ologen
description: phacoemulsification with viscocanalostomy with ologen
arm group label: OloPhacovisco group
other name: phaco-visco-canalostomy with ologen implant
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed AM Gad, MD
role: Principal Investigator
affiliation: Zagazig University
facility: 
country: Egypt
citation: Cillino S, Di Pace F, Cillino G, Casuccio A. Biodegradable collagen matrix implant vs mitomycin-C as an adjuvant in trabeculectomy: a 24-month, randomized clinical trial. Eye (Lond). 2011 Dec;25(12):1598-606. doi: 10.1038/eye.2011.219. Epub 2011 Sep 16.
PMID: 21921953
citation: Narayanaswamy A, Perera SA, Htoon HM, Hoh ST, Seah SK, Wong TT, Aung T. Efficacy and safety of collagen matrix implants in phacotrabeculectomy and comparison with mitomycin C augmented phacotrabeculectomy at 1 year. Clin Exp Ophthalmol. 2013 Aug;41(6):552-60. doi: 10.1111/ceo.12058.
PMID: 23279607
citation: Johnson MS, Sarkisian SR Jr. Using a collagen matrix implant (Ologen) versus mitomycin-C as a wound healing modulator in trabeculectomy with the Ex-PRESS mini glaucoma device: a 12-month retrospective review. J Glaucoma. 2014 Dec;23(9):649-52. doi: 10.1097/IJG.0000000000000018.
PMID: 24240882
citation: Hondur A, Onol M, Hasanreisoglu B. Nonpenetrating glaucoma surgery: meta-analysis of recent results. J Glaucoma. 2008 Mar;17(2):139-46. doi: 10.1097/IJG.0b013e31814b98f7.
PMID: 18344761
citation: Shaarawy T, Mermoud A. Deep sclerectomy in one eye vs deep sclerectomy with collagen implant in the contralateral eye of the same patient: long-term follow-up. Eye (Lond). 2005 Mar;19(3):298-302. doi: 10.1038/sj.eye.6701469.
PMID: 15258610
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Ahmed moamen
investigator title: princibal investigator, lecturer of ophthalmology
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: Undecided
provided document: 