<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/NCT02199158</url>
  </required_header>
  <id_info>
    <org_study_id>iridoplastiaeca</org_study_id>
    <nct_id>NCT02199158</nct_id>
  </id_info>
  <brief_title>Short-term Outcomes of Iridoplasty for Persistent Angle Closure Despite Patent Iridotomies</brief_title>
  <acronym>ALPIECA</acronym>
  <official_title>Short-term Outcomes of Iridoplasty for Persistent Angle Closure Despite Patent Iridotomies An Anterior Segment Optical Coherence Tomography Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Oftalmología Fundación Conde de Valenciana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Oftalmología Fundación Conde de Valenciana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose:&#xD;
&#xD;
      To evaluate short-term angle opening after argon peripheral iridoplasty using AS-OCT and to&#xD;
      report its complications at 1-week and 1-month follow up in patients that did not achieve a&#xD;
      satisfactory clinical angle opening despite patent laser peripheral iridotomy.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Prospective, Interventional case series&#xD;
&#xD;
      Subjects:&#xD;
&#xD;
      Patients with an occludable angle in more than two quadrants in dark room indentation&#xD;
      gonioscopy and patent iridotomies of at least 2 weeks, with assessment of persistent angle&#xD;
      closure aetiology by ultrabiomicroscopy and A-scan ultrasound are included.&#xD;
&#xD;
      Patients will undergo complete examination and AS-OCT before ALPI, one week and one month&#xD;
      after it. We analyzed the images in a masked manner and took the angle measurements (AOD500,&#xD;
      AOD 750, TISA500, TISA750, ARA500, ARA 750, Lens vault) at 0° and 180° as the main outcome&#xD;
      measure to determine effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Argon laser peripheral iridoplasty (ALPI) (Figure 1) is an iris-remodeling&#xD;
      procedure that intends to widen the iridocorneal angle through redistribution of peripheral&#xD;
      iris tension forces close to the trabeculum.&#xD;
&#xD;
      ALPI is effective in patients with plateau iris syndrome and acute angle closure glaucoma but&#xD;
      there is less published about its effectiveness in secondary angle closure. Therefore, we are&#xD;
      going to evaluate this procedure in those patients that did not achieve a satisfactory&#xD;
      clinical angle opening despite patent laser peripheral iridotomy, as long as there was no&#xD;
      contraindication for a new laser procedure and provided that cataract surgery is not viable,&#xD;
      as in clear lens or patients not willing to undergo surgery.&#xD;
&#xD;
      To evaluate its effectiveness, we will use a non-invasive non-contact method through anterior&#xD;
      segment optical coherence tomography (AS-OCT), which transmits and receives light in an&#xD;
      ultrasound-like manner to obtain anterior segment imaging that helps to evaluate the angle&#xD;
      more objectively.&#xD;
&#xD;
      Purpose To evaluate short-term angle opening after argon peripheral iridoplasty using AS-OCT&#xD;
      and to report its complications at 1-week and 1-month follow up in patients with persistent&#xD;
      angle closure despite patent iridotomies.&#xD;
&#xD;
      Study Design Prospective, interventional case series Patients with an occludable angle in&#xD;
      more than two quadrants in dark room dynamic gonioscopy and patent iridotomies of at least 2&#xD;
      weeks were included. A supplemental diagnosis regarding the etiology of persistent angle&#xD;
      closure by ultrabiomicroscopy and A-scan ultrasound will be obtained. Patients who presented&#xD;
      with these criteria to the angle closure clinic at the glaucoma service of our institute&#xD;
      (Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City) between July and&#xD;
      November 2012 were included.&#xD;
&#xD;
      Patients with synechiae of more than one quadrant, advanced glaucomatous damage, prompt&#xD;
      cataract surgery plans and those who did not wish to participate were excluded.&#xD;
&#xD;
      After obtaining informed consent, patients underwent biomicroscopy, gonioscopy, visual&#xD;
      acuity, intraocular pressure and AS-OCT before ALPI, one week and one month after it. The&#xD;
      AS-OCT Visante (Carl Zeiss Meditec, Dublin) took an image of the vertical and horizontal&#xD;
      meridians at the same room illumination of 14 lux measured with a luxometer mobile&#xD;
      application (Apple Inc., Application Manufactory available at the AppStore by June 2012).&#xD;
&#xD;
      Images were analyzed in a masked manner marking scleral spurs and angle recess at 0° and 180°&#xD;
      of the horizontal image.&#xD;
&#xD;
      ALPI was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA) by the&#xD;
      same ophthalmologist (JML). Twenty to 40 spots of 400 mW power with 500 microns of size and&#xD;
      duration of 500 ms were applied. Power was modified arbitrarily until an effective iris&#xD;
      contraction was obtained. It was considered an effective contraction as that which causes a&#xD;
      concentric movement around the laser spot, with minimal iris pigmentation and immediate angle&#xD;
      opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there&#xD;
      was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain.&#xD;
      Pilocarpine was not applied before the procedure in all cases because some eyes had angle&#xD;
      closure secondary to ciliary block and we considered it could worsen the closure in many&#xD;
      cases.&#xD;
&#xD;
      Topical prednisolone acetate was applied every 4 hours for 1 week and brimonidine tartrate&#xD;
      every 12 hours for 1 week .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Angle Aperture</measure>
    <time_frame>1 month</time_frame>
    <description>Angle opening measured by anterior segment optical coherence tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>1 month</time_frame>
    <description>complications reported by patient and/or examiner</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Angle Closure Glaucoma</condition>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Argon Laser Peripheral Iridoplasty</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ALPI was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA) by the same ophthalmologist (JML). Twenty to 40 spots of 400 mW power with 500 microns of size and duration of 500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. It was considered an effective contraction as that which causes a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Argon Laser Peripheral Iridoplasty</intervention_name>
    <description>ALPI was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA) by the same ophthalmologist (JML). Twenty to 40 spots of 400 mW power with 500 microns of size and duration of 500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. It was considered an effective contraction as that which causes a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain.</description>
    <arm_group_label>Argon Laser Peripheral Iridoplasty</arm_group_label>
    <other_name>ALPI</other_name>
    <other_name>Iridoplasty</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an occludable angle in more than two quadrants in dark room dynamic&#xD;
             gonioscopy and patent iridotomies of at least 2 weeks were included&#xD;
&#xD;
          -  A supplemental diagnosis regarding the etiology of persistent angle closure by&#xD;
             ultrabiomicroscopy and A-scan ultrasound was obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with synechiae of more than one quadrant&#xD;
&#xD;
          -  Advanced glaucomatous damage&#xD;
&#xD;
          -  Prompt cataract surgery plans and those who did not wish to participate were excluded&#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>Jorge-Emmanuel Morales-León, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>&quot;Fundación Conde de Valenciana&quot; Ophthalmology Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>&quot;Fundación Conde de Valenciana&quot; Ophthalmology Institute</name>
      <address>
        <city>Mexico City</city>
        <state>Obrera</state>
        <zip>06800</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Ritch R, Tham CC, Lam DS. Argon laser peripheral iridoplasty (ALPI): an update. Surv Ophthalmol. 2007 May-Jun;52(3):279-88. doi: 10.1016/j.survophthal.2007.02.006.</citation>
    <PMID>17472803</PMID>
  </reference>
  <reference>
    <citation>Ritch R, Tham CC, Lam DS. Long-term success of argon laser peripheral iridoplasty in the management of plateau iris syndrome. Ophthalmology. 2004 Jan;111(1):104-8. doi: 10.1016/j.ophtha.2003.05.001.</citation>
    <PMID>14711720</PMID>
  </reference>
  <reference>
    <citation>Fu J, Qing GP, Wang NL, Wang HZ. Efficacy of laser peripheral iridoplasty and iridotomy on medically refractory patients with acute primary angle closure: a three year outcome. Chin Med J (Engl). 2013 Jan;126(1):41-5.</citation>
    <PMID>23286475</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>iridoplasty</keyword>
  <keyword>angle</keyword>
  <keyword>glaucoma</keyword>
  <keyword>anterior chamber</keyword>
  <keyword>laser treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Angle-Closure</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/NCT02199158
org study id: iridoplastiaeca
nct id: NCT02199158
lead sponsor: 
has dmc: No
Purpose:

      To evaluate short-term angle opening after argon peripheral iridoplasty using AS-OCT and to
      report its complications at 1-week and 1-month follow up in patients that did not achieve a
      satisfactory clinical angle opening despite patent laser peripheral iridotomy.

      Design:

      Prospective, Interventional case series

      Subjects:

      Patients with an occludable angle in more than two quadrants in dark room indentation
      gonioscopy and patent iridotomies of at least 2 weeks, with assessment of persistent angle
      closure aetiology by ultrabiomicroscopy and A-scan ultrasound are included.

      Patients will undergo complete examination and AS-OCT before ALPI, one week and one month
      after it. We analyzed the images in a masked manner and took the angle measurements (AOD500,
      AOD 750, TISA500, TISA750, ARA500, ARA 750, Lens vault) at 0° and 180° as the main outcome
      measure to determine effectiveness.
Background Argon laser peripheral iridoplasty (ALPI) (Figure 1) is an iris-remodeling
      procedure that intends to widen the iridocorneal angle through redistribution of peripheral
      iris tension forces close to the trabeculum.

      ALPI is effective in patients with plateau iris syndrome and acute angle closure glaucoma but
      there is less published about its effectiveness in secondary angle closure. Therefore, we are
      going to evaluate this procedure in those patients that did not achieve a satisfactory
      clinical angle opening despite patent laser peripheral iridotomy, as long as there was no
      contraindication for a new laser procedure and provided that cataract surgery is not viable,
      as in clear lens or patients not willing to undergo surgery.

      To evaluate its effectiveness, we will use a non-invasive non-contact method through anterior
      segment optical coherence tomography (AS-OCT), which transmits and receives light in an
      ultrasound-like manner to obtain anterior segment imaging that helps to evaluate the angle
      more objectively.

      Purpose To evaluate short-term angle opening after argon peripheral iridoplasty using AS-OCT
      and to report its complications at 1-week and 1-month follow up in patients with persistent
      angle closure despite patent iridotomies.

      Study Design Prospective, interventional case series Patients with an occludable angle in
      more than two quadrants in dark room dynamic gonioscopy and patent iridotomies of at least 2
      weeks were included. A supplemental diagnosis regarding the etiology of persistent angle
      closure by ultrabiomicroscopy and A-scan ultrasound will be obtained. Patients who presented
      with these criteria to the angle closure clinic at the glaucoma service of our institute
      (Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City) between July and
      November 2012 were included.

      Patients with synechiae of more than one quadrant, advanced glaucomatous damage, prompt
      cataract surgery plans and those who did not wish to participate were excluded.

      After obtaining informed consent, patients underwent biomicroscopy, gonioscopy, visual
      acuity, intraocular pressure and AS-OCT before ALPI, one week and one month after it. The
      AS-OCT Visante (Carl Zeiss Meditec, Dublin) took an image of the vertical and horizontal
      meridians at the same room illumination of 14 lux measured with a luxometer mobile
      application (Apple Inc., Application Manufactory available at the AppStore by June 2012).

      Images were analyzed in a masked manner marking scleral spurs and angle recess at 0° and 180°
      of the horizontal image.

      ALPI was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA) by the
      same ophthalmologist (JML). Twenty to 40 spots of 400 mW power with 500 microns of size and
      duration of 500 ms were applied. Power was modified arbitrarily until an effective iris
      contraction was obtained. It was considered an effective contraction as that which causes a
      concentric movement around the laser spot, with minimal iris pigmentation and immediate angle
      opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there
      was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain.
      Pilocarpine was not applied before the procedure in all cases because some eyes had angle
      closure secondary to ciliary block and we considered it could worsen the closure in many
      cases.

      Topical prednisolone acetate was applied every 4 hours for 1 week and brimonidine tartrate
      every 12 hours for 1 week .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Angle Aperture
time frame: 1 month
description: Angle opening measured by anterior segment optical coherence tomography
measure: Complications
time frame: 1 month
description: complications reported by patient and/or examiner
arm group label: Argon Laser Peripheral Iridoplasty
arm group type: Experimental
description: ALPI was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA) by the same ophthalmologist (JML). Twenty to 40 spots of 400 mW power with 500 microns of size and duration of 500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. It was considered an effective contraction as that which causes a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain.
intervention type: Procedure
intervention name: Argon Laser Peripheral Iridoplasty
description: ALPI was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA) by the same ophthalmologist (JML). Twenty to 40 spots of 400 mW power with 500 microns of size and duration of 500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. It was considered an effective contraction as that which causes a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain.
arm group label: Argon Laser Peripheral Iridoplasty
other name: ALPI
other name: Iridoplasty
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jorge-Emmanuel Morales-León, MD
role: Principal Investigator
affiliation: "Fundación Conde de Valenciana" Ophthalmology Institute
facility: 
country: Mexico
citation: Ritch R, Tham CC, Lam DS. Argon laser peripheral iridoplasty (ALPI): an update. Surv Ophthalmol. 2007 May-Jun;52(3):279-88. doi: 10.1016/j.survophthal.2007.02.006.
PMID: 17472803
citation: Ritch R, Tham CC, Lam DS. Long-term success of argon laser peripheral iridoplasty in the management of plateau iris syndrome. Ophthalmology. 2004 Jan;111(1):104-8. doi: 10.1016/j.ophtha.2003.05.001.
PMID: 14711720
citation: Fu J, Qing GP, Wang NL, Wang HZ. Efficacy of laser peripheral iridoplasty and iridotomy on medically refractory patients with acute primary angle closure: a three year outcome. Chin Med J (Engl). 2013 Jan;126(1):41-5.
PMID: 23286475
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Angle-Closure