<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/NCT04430647</url>
  </required_header>
  <id_info>
    <org_study_id>Phaco-UCP in OAG and cataract</org_study_id>
    <nct_id>NCT04430647</nct_id>
  </id_info>
  <brief_title>Phaco-UCP Versus Phaco Alone for OAG and Cataract</brief_title>
  <official_title>Phaco-UCP; Combined Phacoemulsification and Ultrasound Ciliary Plasty Versus Phacoemulsification Alone for Management of Coexisting Cataract and Open Angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ameera Gamal Abdelhameed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dar Alshifa hospital Kuwait</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mansoura 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 study was carried out to evaluate the safety and efficacy of combined&#xD;
      phacoemulsification and Ultrasound ciliary plasty (Phaco-UCP) as a first-line surgical&#xD;
      treatment of coexisting cataract and op&#xD;
&#xD;
      /en angle glaucoma compared to phacoemulsification alone. To our knowledge, this is the first&#xD;
      report of results of combined Phaco-UCP&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the study involved 61 eyes of 61 patients with coexisting cataract and open angle glaucoma,&#xD;
      31 eyes were managed with Phaco-UCP and 30 eyes of age and sex matched patients were managed&#xD;
      with phacoemulsification alone.&#xD;
&#xD;
      Patients were randomized for either combined phacoemulsification and ultrasound ciliary&#xD;
      plasty (Phaco-UCP) (the study group) or phacoemulsification alone (the control group). All&#xD;
      surgeries were performed by one experienced surgeon (Y EZ).&#xD;
&#xD;
      Preoperative evaluation included manifest refraction, BCVA measurement, slit-lamp&#xD;
      biomicroscopy, gonioscopy, indirect ophthalmoscopy, measurement of IOP with Goldmann&#xD;
      applanation tonometry (average of 3 readings taken). Corneal diameter (White-to-white) and&#xD;
      axial length measurement were done using IOL Master 500 (Carl Zeiss Meditec AG., Germany).&#xD;
      Ultrasound pachymetry with Tomey SP-100 (Tomey Corp. Nagoya, Japan) and visual fields using&#xD;
      Humphrey Field Analyzer (24-2, SITA, standard program Carl Zeiss Meditec AG., Germany) were&#xD;
      also performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reduction in intraocular pressure</measure>
    <time_frame>18 months postoperative</time_frame>
    <description>Qualified Success was defined as an IOP reduction of at least 20 % from baseline value, with an IOP that is between 6 - 21 mm Hg, without the need for additional antiglaucoma medications or glaucoma surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>reduction in r the number of antiglaucoma medications.</measure>
    <time_frame>18 months postoperative</time_frame>
    <description>reduction of the number of antiglaucoma medication or at least no increase in the number</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BCVA improvement</measure>
    <time_frame>18 months postoperative</time_frame>
    <description>improvement of best corrected visual acuity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative and postoperative complications.</measure>
    <time_frame>intraoperative and 18 months postoperative</time_frame>
    <description>hyphema or vitreous hemorrhage necessitating surgical intervention, choroidal hemorrhage, chronic uveitis, endophthalmitis, hypotony (IOP ≤ 5 mm Hg), phthisis, IOL dislocation, and retinal detachment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Cataract</condition>
  <condition>Glaucoma, Open-Angle</condition>
  <arm_group>
    <arm_group_label>phaco-UCP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Under peribulbar anesthesia, UCP was performed first, followed by phacoemulsification. UCP was performed using the same technique described before [18]. For all treatments, 2nd generation probe was used (EyeOP1, Eye Tech care; France) with the same parameters; Operating frequency was 21 MHz. Number of sectors activated was 6. Acoustic power was 2.45 W; duration of each shot was 8s; and the time between shots was 20s. The probe diameter (11, 12 or 13 mm) was determined according to the eye's biometric readings. The coupling cone was centered on the eye and kept in place with low vacuum suction, followed by introduction of the treatment probe inside the cone, then activation of the transducers by constantly pressing the foot switch. Once UCP treatment was finished, phacoemulsification was commenced</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phaco alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A standard phacoemulsification was performed with 2.2 mm clear corneal incision, continuous curvilinear capsulorhexis, phacoemulsification and intrabagal implantation of foldable acrylic intraocular lens (AcrySof® IQ SN60WF monofocal; Alcon Laboratories Inc, Fort Worth, TX, USA) for all patients. Irrigation-aspiration was performed for at least 30 seconds to remove any viscoelastic from the anterior chamber. Reformation of the anterior chamber was done with balanced saline solution (BSS), followed by hydration of the corneal wound and side port.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)</intervention_name>
    <description>performing ultrasound ciliary plasty then performing standard phacoemulsification</description>
    <arm_group_label>phaco-UCP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Phacoemulsification alone</intervention_name>
    <description>standard phacoemulsification for catarct extraction</description>
    <arm_group_label>Phaco alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients diagnosed with POAG or pseudoexfoliation glaucoma with coexisting visually&#xD;
             significant cataract that required phacoemulsification&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with any other type of glaucoma, including narrow angle glaucoma,&#xD;
             neovascular, uveitic or angle recession glaucoma, patients with advanced glaucoma&#xD;
             characterized by advanced optic disc cupping or visual field damage, history of&#xD;
             glaucoma or intraocular surgery and other ocular diseases that would affect safety or&#xD;
             interfere with the procedure. We also excluded patients with incomplete follow-up or&#xD;
             missing data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magda Torky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
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    <PMID>22133988</PMID>
  </reference>
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    <citation>Francis BA, Sarkisian SR, Tan JC (2017). Minimally invasive glaucoma surgery: A practical guide. 1st ed. New York: Thieme.</citation>
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  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Ameera Gamal Abdelhameed</investigator_full_name>
    <investigator_title>Lecturer of Ophthalmology</investigator_title>
  </responsible_party>
  <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/NCT04430647
org study id: Phaco-UCP in OAG and cataract
nct id: NCT04430647
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was carried out to evaluate the safety and efficacy of combined
      phacoemulsification and Ultrasound ciliary plasty (Phaco-UCP) as a first-line surgical
      treatment of coexisting cataract and op

      /en angle glaucoma compared to phacoemulsification alone. To our knowledge, this is the first
      report of results of combined Phaco-UCP
the study involved 61 eyes of 61 patients with coexisting cataract and open angle glaucoma,
      31 eyes were managed with Phaco-UCP and 30 eyes of age and sex matched patients were managed
      with phacoemulsification alone.

      Patients were randomized for either combined phacoemulsification and ultrasound ciliary
      plasty (Phaco-UCP) (the study group) or phacoemulsification alone (the control group). All
      surgeries were performed by one experienced surgeon (Y EZ).

      Preoperative evaluation included manifest refraction, BCVA measurement, slit-lamp
      biomicroscopy, gonioscopy, indirect ophthalmoscopy, measurement of IOP with Goldmann
      applanation tonometry (average of 3 readings taken). Corneal diameter (White-to-white) and
      axial length measurement were done using IOL Master 500 (Carl Zeiss Meditec AG., Germany).
      Ultrasound pachymetry with Tomey SP-100 (Tomey Corp. Nagoya, Japan) and visual fields using
      Humphrey Field Analyzer (24-2, SITA, standard program Carl Zeiss Meditec AG., Germany) were
      also performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: reduction in intraocular pressure
time frame: 18 months postoperative
description: Qualified Success was defined as an IOP reduction of at least 20 % from baseline value, with an IOP that is between 6 - 21 mm Hg, without the need for additional antiglaucoma medications or glaucoma surgery
measure: reduction in r the number of antiglaucoma medications.
time frame: 18 months postoperative
description: reduction of the number of antiglaucoma medication or at least no increase in the number
measure: BCVA improvement
time frame: 18 months postoperative
description: improvement of best corrected visual acuity
measure: intraoperative and postoperative complications.
time frame: intraoperative and 18 months postoperative
description: hyphema or vitreous hemorrhage necessitating surgical intervention, choroidal hemorrhage, chronic uveitis, endophthalmitis, hypotony (IOP ≤ 5 mm Hg), phthisis, IOL dislocation, and retinal detachment.
arm group label: phaco-UCP
arm group type: Experimental
description: Under peribulbar anesthesia, UCP was performed first, followed by phacoemulsification. UCP was performed using the same technique described before [18]. For all treatments, 2nd generation probe was used (EyeOP1, Eye Tech care; France) with the same parameters; Operating frequency was 21 MHz. Number of sectors activated was 6. Acoustic power was 2.45 W; duration of each shot was 8s; and the time between shots was 20s. The probe diameter (11, 12 or 13 mm) was determined according to the eye's biometric readings. The coupling cone was centered on the eye and kept in place with low vacuum suction, followed by introduction of the treatment probe inside the cone, then activation of the transducers by constantly pressing the foot switch. Once UCP treatment was finished, phacoemulsification was commenced
arm group label: Phaco alone
arm group type: Active Comparator
description: A standard phacoemulsification was performed with 2.2 mm clear corneal incision, continuous curvilinear capsulorhexis, phacoemulsification and intrabagal implantation of foldable acrylic intraocular lens (AcrySof® IQ SN60WF monofocal; Alcon Laboratories Inc, Fort Worth, TX, USA) for all patients. Irrigation-aspiration was performed for at least 30 seconds to remove any viscoelastic from the anterior chamber. Reformation of the anterior chamber was done with balanced saline solution (BSS), followed by hydration of the corneal wound and side port.
intervention type: Procedure
intervention name: combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)
description: performing ultrasound ciliary plasty then performing standard phacoemulsification
arm group label: phaco-UCP
intervention type: Procedure
intervention name: Phacoemulsification alone
description: standard phacoemulsification for catarct extraction
arm group label: Phaco alone
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Magda Torky, MD
role: Principal Investigator
affiliation: Mansoura University
facility: 
country: Egypt
citation: Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol. 2012 May;96(5):614-8. doi: 10.1136/bjophthalmol-2011-300539. Epub 2011 Dec 1.
PMID: 22133988
citation: Chen DZ, Koh V, Sng C, Aquino MC, Chew P. Complications and outcomes of primary phacotrabeculectomy with mitomycin C in a multi-ethnic asian population. PLoS One. 2015 Mar 16;10(3):e0118852. doi: 10.1371/journal.pone.0118852. eCollection 2015.
PMID: 25775362
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responsible party type: Sponsor-Investigator
investigator affiliation: Mansoura University
investigator full name: Ameera Gamal Abdelhameed
investigator title: Lecturer of Ophthalmology
mesh term: Glaucoma
mesh term: Cataract
mesh term: Glaucoma, Open-Angle