<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/NCT01693575</url>
  </required_header>
  <id_info>
    <org_study_id>APX-2012MMC</org_study_id>
    <nct_id>NCT01693575</nct_id>
  </id_info>
  <brief_title>Use of APX 100 Device for Small-pupil Cataract Surgery and Intraoperative Floppy-iris Syndrome</brief_title>
  <official_title>Use of APX 100 Device for Expansion of Small Pupil in Cataract Surgery and Management of Intraoperative Floppy-iris Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to gather clinical data and safety information on the use of APX&#xD;
      100 device for small-pupil cataract surgery and the management of intraoperative floppy iris&#xD;
      syndrome (IFIS) during cataract surgery.&#xD;
&#xD;
      The APX 100, a FDA-approved device (510K exempt), is a disposable stainless steal sterile&#xD;
      device for mechanical expansion of pupillary diameter during intraocular surgery. The APX 100&#xD;
      is inserted to the anterior chamber of the eye through standard clear corneal incisions. The&#xD;
      device is then located on the pupil's border between the iris and the anterior lens capsule&#xD;
      and the pupil's diameter is expanded.&#xD;
&#xD;
      The APX 100 will be used in standard phacoemulsification cataract extraction surgery when&#xD;
      small pupil diameter (&lt;4.5 mm) is recognized preoperatively or develops intraoperatively due&#xD;
      to IFIS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In cases of small-pupil cataract surgery and intraoperative floppy iris syndrome (IFIS) the&#xD;
      potential of intraoperative complications is substantial. The risk of posterior lens capsule&#xD;
      tear, dropped nucleus fragments and vitreous loss increases.&#xD;
&#xD;
      There are several surgical methods and commercial products designed to deal with small pupil&#xD;
      diameter in ocular surgery. Among these, pupil viscodilation with ophthalmic viscosurgical&#xD;
      devices, mechanical dilation of pupil with ocular spatula, radial incisions in pupil's&#xD;
      sphincter and iris retractors (iris hooks, Malyugin ring, Perfect Pupil ring), are the most&#xD;
      popular. Each method has its advantages and disadvantages.&#xD;
&#xD;
      Our group developed an innovative iris retractor device named APX 100. It is a disposable&#xD;
      stainless steal sterile device designed for mechanical expansion of pupillary diameter during&#xD;
      intraocular surgery. The device was approved by the FDA (510K exempt) for iris retraction in&#xD;
      small pupil diameters and in IFIS. It comes in a disposable kit with 2 iris retractors and 2&#xD;
      forceps.&#xD;
&#xD;
      The study was designed to help us gain more clinical knowledge about the surgical advantages&#xD;
      and safety of APX 100 beyond registration data.&#xD;
&#xD;
      Patients designated for standard phacoemulsification cataract extraction with small pupil&#xD;
      diameter or with documented IFIS in previous eye will be enrolled to the study. The APX 100&#xD;
      will be used intraoperatively in order to retract the iris and expand the pupil. All other&#xD;
      cataract extraction surgical stages will remain unchanged.&#xD;
&#xD;
      The study includes five study visits: preoperative examination, cataract extraction surgery,&#xD;
      first postoperative day, 1 week postoperatively, 1 month postoperatively. All data regarding&#xD;
      the intraoperative use of the device and its effect on ocular tissues and final visual acuity&#xD;
      will be documented in the patients' files.&#xD;
&#xD;
      The preoperative visit will include a thorough eye examination, visual acuity test,&#xD;
      intraocular pressure measurement, subjective refraction, measurements to decide the&#xD;
      intraocular lens power, endothelial cell counts, corneal topography and anterior segment&#xD;
      photography. The second visit will be the cataract extraction surgery itself during which the&#xD;
      APX 100 device will be used. On the first postoperative day visual acuity will be tested,&#xD;
      intraocular pressure will be measured, a thorough eye examination will be performed and&#xD;
      treatment with topical third-generation fluoroquinolone antibiotics and corticosteroids drops&#xD;
      will be initiated. Examination one week postoperatively will be the same as in the previous&#xD;
      visit, only the topical treatment regimen will be changed - topical antibiotics will be&#xD;
      stopped and the dosage of the corticosteroids drops will be lowered and maintained for&#xD;
      additional three weeks. The last study visit, 1 month postoperatively, will include&#xD;
      subjective refraction, best corrected visual acuity, a thorough eye examination, intraocular&#xD;
      pressure measurement, endothelial cell counts, corneal topography and anterior segment&#xD;
      photography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of APX 100 device</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the degree of pupil expansion by measuring the pupil diameter in millimeters after positioning the APX 100 device appropriately in small-pupil cataract surgery and in the management of intraoperative floppy iris syndrome (IFIS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of APX 100 device</measure>
    <time_frame>6 months</time_frame>
    <description>To assess the rate of the possible adverse effects on ocular tissues (cornea, iris, lens and ciliary body) by the use of APX 100 device.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Miosis Disorder</condition>
  <condition>Intraoperative Floppy Iris Syndrome</condition>
  <arm_group>
    <arm_group_label>Pupil expansion with APX 100 device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of APX 100 device during standard phacoemulsification cataract extraction surgery in patients with small pupil diameter (&lt;4.5 mm) or with documented intraoperative floppy iris syndrome in previous eye.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pupil expansion with APX 100 device</intervention_name>
    <description>Patients with small pupils (&lt;4.5 mm) that would not dilate pharmacologically or small pupils that develop intraoperatively due to intraoperative floppy iris syndrome (IFIS) will be assigned to APX 100 device intervention during standard phacoemulsification cataract surgery. After creating two standard clear corneal incisions in the horizontal meridians, two APX 100 retractors will be inserted to the anterior chamber of the eye 180 degrees apart with special forceps, one retractor at a time, and will be located on the pupil's border between the iris and the anterior lens capsule. Then, the devices will be released from the forceps and the pupil diameter will expand. The next steps of the surgery will remain unchanged. After the implantation of the intraocular lens (IOL) in the capsular bag the APX 100 retractors will be removed the same way as inserted. The clear corneal incisions will then be closed by hydration.</description>
    <arm_group_label>Pupil expansion with APX 100 device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pupil diameter of less than 4.5 mm&#xD;
&#xD;
          -  Second eye cataract extraction operation with documented intraoperative floppy iris&#xD;
             syndrome in the first eye, regardless of pupil diameter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18 years.&#xD;
&#xD;
          -  Only functional eye.&#xD;
&#xD;
          -  Active intraocular inflammation (uveitis).&#xD;
&#xD;
          -  Substantial iris defects&#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>Ehud Assia, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>April 15, 2015</last_update_submitted>
  <last_update_submitted_qc>April 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Small pupil cataract surgery</keyword>
  <keyword>Intraoperative floppy iris syndrome (IFIS)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Miosis</mesh_term>
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Syndrome</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/NCT01693575
org study id: APX-2012MMC
nct id: NCT01693575
lead sponsor: 
has dmc: No
The purpose of the study is to gather clinical data and safety information on the use of APX
      100 device for small-pupil cataract surgery and the management of intraoperative floppy iris
      syndrome (IFIS) during cataract surgery.

      The APX 100, a FDA-approved device (510K exempt), is a disposable stainless steal sterile
      device for mechanical expansion of pupillary diameter during intraocular surgery. The APX 100
      is inserted to the anterior chamber of the eye through standard clear corneal incisions. The
      device is then located on the pupil's border between the iris and the anterior lens capsule
      and the pupil's diameter is expanded.

      The APX 100 will be used in standard phacoemulsification cataract extraction surgery when
      small pupil diameter (<4.5 mm) is recognized preoperatively or develops intraoperatively due
      to IFIS.
In cases of small-pupil cataract surgery and intraoperative floppy iris syndrome (IFIS) the
      potential of intraoperative complications is substantial. The risk of posterior lens capsule
      tear, dropped nucleus fragments and vitreous loss increases.

      There are several surgical methods and commercial products designed to deal with small pupil
      diameter in ocular surgery. Among these, pupil viscodilation with ophthalmic viscosurgical
      devices, mechanical dilation of pupil with ocular spatula, radial incisions in pupil's
      sphincter and iris retractors (iris hooks, Malyugin ring, Perfect Pupil ring), are the most
      popular. Each method has its advantages and disadvantages.

      Our group developed an innovative iris retractor device named APX 100. It is a disposable
      stainless steal sterile device designed for mechanical expansion of pupillary diameter during
      intraocular surgery. The device was approved by the FDA (510K exempt) for iris retraction in
      small pupil diameters and in IFIS. It comes in a disposable kit with 2 iris retractors and 2
      forceps.

      The study was designed to help us gain more clinical knowledge about the surgical advantages
      and safety of APX 100 beyond registration data.

      Patients designated for standard phacoemulsification cataract extraction with small pupil
      diameter or with documented IFIS in previous eye will be enrolled to the study. The APX 100
      will be used intraoperatively in order to retract the iris and expand the pupil. All other
      cataract extraction surgical stages will remain unchanged.

      The study includes five study visits: preoperative examination, cataract extraction surgery,
      first postoperative day, 1 week postoperatively, 1 month postoperatively. All data regarding
      the intraoperative use of the device and its effect on ocular tissues and final visual acuity
      will be documented in the patients' files.

      The preoperative visit will include a thorough eye examination, visual acuity test,
      intraocular pressure measurement, subjective refraction, measurements to decide the
      intraocular lens power, endothelial cell counts, corneal topography and anterior segment
      photography. The second visit will be the cataract extraction surgery itself during which the
      APX 100 device will be used. On the first postoperative day visual acuity will be tested,
      intraocular pressure will be measured, a thorough eye examination will be performed and
      treatment with topical third-generation fluoroquinolone antibiotics and corticosteroids drops
      will be initiated. Examination one week postoperatively will be the same as in the previous
      visit, only the topical treatment regimen will be changed - topical antibiotics will be
      stopped and the dosage of the corticosteroids drops will be lowered and maintained for
      additional three weeks. The last study visit, 1 month postoperatively, will include
      subjective refraction, best corrected visual acuity, a thorough eye examination, intraocular
      pressure measurement, endothelial cell counts, corneal topography and anterior segment
      photography.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of APX 100 device
time frame: 6 months
description: To assess the degree of pupil expansion by measuring the pupil diameter in millimeters after positioning the APX 100 device appropriately in small-pupil cataract surgery and in the management of intraoperative floppy iris syndrome (IFIS).
measure: Safety of APX 100 device
time frame: 6 months
description: To assess the rate of the possible adverse effects on ocular tissues (cornea, iris, lens and ciliary body) by the use of APX 100 device.
arm group label: Pupil expansion with APX 100 device
arm group type: Experimental
description: Use of APX 100 device during standard phacoemulsification cataract extraction surgery in patients with small pupil diameter (<4.5 mm) or with documented intraoperative floppy iris syndrome in previous eye.
intervention type: Device
intervention name: Pupil expansion with APX 100 device
description: Patients with small pupils (<4.5 mm) that would not dilate pharmacologically or small pupils that develop intraoperatively due to intraoperative floppy iris syndrome (IFIS) will be assigned to APX 100 device intervention during standard phacoemulsification cataract surgery. After creating two standard clear corneal incisions in the horizontal meridians, two APX 100 retractors will be inserted to the anterior chamber of the eye 180 degrees apart with special forceps, one retractor at a time, and will be located on the pupil's border between the iris and the anterior lens capsule. Then, the devices will be released from the forceps and the pupil diameter will expand. The next steps of the surgery will remain unchanged. After the implantation of the intraocular lens (IOL) in the capsular bag the APX 100 retractors will be removed the same way as inserted. The clear corneal incisions will then be closed by hydration.
arm group label: Pupil expansion with APX 100 device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ehud Assia, M.D
role: Principal Investigator
affiliation: Meir Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Miosis
mesh term: Cataract
mesh term: Syndrome