<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/NCT01693211</url>
  </required_header>
  <id_info>
    <org_study_id>1118</org_study_id>
    <nct_id>NCT01693211</nct_id>
  </id_info>
  <brief_title>Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre</brief_title>
  <acronym>1118</acronym>
  <official_title>Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technolas Perfect Vision GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technolas Perfect Vision GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomized study evaluating the circularity of the anterior&#xD;
      capsulotomy performed by the VICTUS femtosecond work station (Group A) versus the manual&#xD;
      capsulotomy (Group B) of a minimum of 22 eyes and maximum of 30 eyes per group diagnosed with&#xD;
      cataract, scheduled to undergo removal by phacoemulsification with intraocular lens&#xD;
      implantation in SNEC.&#xD;
&#xD;
      The primary study end point is to determine if the circularity of the created rhexis is&#xD;
      better in Group A as compared to Group B.&#xD;
&#xD;
      The secondary study end point is to determine the diameter of rhexis is more precise and&#xD;
      reproducible in Group A as compared to Group B.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical study is a controlled, open, randomized, prospective, single-centre,&#xD;
      single-surgeon eye study to determine the precision of intraocular cuts for anterior&#xD;
      capsulotomy in connection to cataract surgery and IOL implantation. The cuts are applied by&#xD;
      means of the VICTUS femtosecond laser system using a cylindrical cut pattern with diameter&#xD;
      and height dependent on anterior chamber depth, pupil diameter and ocular lens size for Group&#xD;
      A and the manual surgery technique for Group B.&#xD;
&#xD;
      The allocation of the surgery technique will be randomized between the study patient. Each&#xD;
      surgery technique represents a study group. In Group A the anterior capsulotomy and lens&#xD;
      fragmentation will be performed by means of femtosecond laser surgery. Group B acts as a&#xD;
      control group where the capsulotomy as well as the lens fragmentation is performed manually.&#xD;
&#xD;
      The hypothesis of the study is that by means of intraocular, laser-induced cuts, circularity&#xD;
      of the capsulotomy can be improved in a safe and effective way.&#xD;
&#xD;
      A detailed pre-operative examination will ensure that every interested and willing patient&#xD;
      fulfils the inclusion criteria of this study. Post-operative examinations, which should&#xD;
      document the success of the treatment, are to be carried out after 1-day, 1-week, 1-month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Circularity of created rhexis</measure>
    <time_frame>intraoperative</time_frame>
    <description>The primary study end point is to determine if the circularity of the created rhexis is better in Group A as compared to Group B. On the day of surgery immediately after the creation of the rhexis via an recorded surgical video.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diameter of the created rhexis</measure>
    <time_frame>intraoperative</time_frame>
    <description>The secondary study end point is to determine the diameter of rhexis is more precise and reproducible in Group A as compared to Group B. On the day of surgery immediately after the creation of the rhexis via an recorded surgical video.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Centration of the created rhexis relative to the pupil</measure>
    <time_frame>surgery day, 1-Day, 1-week, 1-Month</time_frame>
    <description>The additional outcome is to determine if the centration of the created rhexis relative to the pupil is better in Group A as compared to Group B. On the day of surgery immediately after the creation of the rhexis via an recorded surgical video and postoperative (1-Day, 1-week, 1-Month) based on slit lamp pictures.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Primary Disease: Cataract</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsulorhexis and pre-fragmentation of the nucleus are performed by the femtosecond laser.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Capulorhexis and nuclear fragmentation are performed manually.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)</intervention_name>
    <description>Capsulotomy and pre-fragmentation of the nucleus are performed by the femtosecond laser.</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Manual (CCC technique with Utrata forceps)</intervention_name>
    <description>Capsulorhexis and pre-fragmentation are performed manually.</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consenting patients undergoing phacoemulsification and IOL implant surgery for&#xD;
             cataract, the diagnosis of which has been confirmed by another investigator.&#xD;
&#xD;
          -  Clear cornea media&#xD;
&#xD;
          -  Pupil must be able to dilate to at least 6mm in diameter measured with the pupil gauge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing posterior capsule rupture Difference between maximum and minimum K-values&#xD;
             must not be more than 5 D. The maximum K- value may not exceed 60 D and the minimal&#xD;
             value may not be smaller than 37 D.&#xD;
&#xD;
          -  Corneal disease or pathology that precludes transmission of laser wavelength or&#xD;
             distortion of laser light.&#xD;
&#xD;
          -  Subjects with a poorly dilating pupil or other defect of the pupil that prevents the&#xD;
             iris from adequate retraction peripherally.&#xD;
&#xD;
          -  Lens/zonular instability such as, but not restricted to, Marfan's Syndrome,&#xD;
             Pseudoexfoliation Syndrome, etc.&#xD;
&#xD;
          -  Previous intraocular or corneal surgery of any kind, including any type of surgery for&#xD;
             either refractive or therapeutic purposes in either eye.&#xD;
&#xD;
          -  Patients with disorders of the ocular muscle, such as nystagmus or strabismus&#xD;
             Keratoconus&#xD;
&#xD;
          -  ACD &lt; 1.8 mm or ACD &gt; 4.5 mm&#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>Soon Phaik Chee, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Singapore National Eye Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Singapore National Eye Centre</name>
      <address>
        <city>Singapore</city>
        <zip>168751</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <link>
    <url>http://www.technolaspv.com/</url>
    <description>Sponsor</description>
  </link>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>June 30, 2014</last_update_submitted>
  <last_update_submitted_qc>June 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>femtosecond laser</keyword>
  <keyword>cataract</keyword>
  <keyword>control study</keyword>
  <keyword>prospective</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</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/NCT01693211
org study id: 1118
nct id: NCT01693211
lead sponsor: 
has dmc: No
This is a prospective, randomized study evaluating the circularity of the anterior
      capsulotomy performed by the VICTUS femtosecond work station (Group A) versus the manual
      capsulotomy (Group B) of a minimum of 22 eyes and maximum of 30 eyes per group diagnosed with
      cataract, scheduled to undergo removal by phacoemulsification with intraocular lens
      implantation in SNEC.

      The primary study end point is to determine if the circularity of the created rhexis is
      better in Group A as compared to Group B.

      The secondary study end point is to determine the diameter of rhexis is more precise and
      reproducible in Group A as compared to Group B.
This clinical study is a controlled, open, randomized, prospective, single-centre,
      single-surgeon eye study to determine the precision of intraocular cuts for anterior
      capsulotomy in connection to cataract surgery and IOL implantation. The cuts are applied by
      means of the VICTUS femtosecond laser system using a cylindrical cut pattern with diameter
      and height dependent on anterior chamber depth, pupil diameter and ocular lens size for Group
      A and the manual surgery technique for Group B.

      The allocation of the surgery technique will be randomized between the study patient. Each
      surgery technique represents a study group. In Group A the anterior capsulotomy and lens
      fragmentation will be performed by means of femtosecond laser surgery. Group B acts as a
      control group where the capsulotomy as well as the lens fragmentation is performed manually.

      The hypothesis of the study is that by means of intraocular, laser-induced cuts, circularity
      of the capsulotomy can be improved in a safe and effective way.

      A detailed pre-operative examination will ensure that every interested and willing patient
      fulfils the inclusion criteria of this study. Post-operative examinations, which should
      document the success of the treatment, are to be carried out after 1-day, 1-week, 1-month.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Circularity of created rhexis
time frame: intraoperative
description: The primary study end point is to determine if the circularity of the created rhexis is better in Group A as compared to Group B. On the day of surgery immediately after the creation of the rhexis via an recorded surgical video.
measure: Diameter of the created rhexis
time frame: intraoperative
description: The secondary study end point is to determine the diameter of rhexis is more precise and reproducible in Group A as compared to Group B. On the day of surgery immediately after the creation of the rhexis via an recorded surgical video.
measure: Centration of the created rhexis relative to the pupil
time frame: surgery day, 1-Day, 1-week, 1-Month
description: The additional outcome is to determine if the centration of the created rhexis relative to the pupil is better in Group A as compared to Group B. On the day of surgery immediately after the creation of the rhexis via an recorded surgical video and postoperative (1-Day, 1-week, 1-Month) based on slit lamp pictures.
arm group label: Group A
arm group type: Experimental
description: Capsulorhexis and pre-fragmentation of the nucleus are performed by the femtosecond laser.
arm group label: Group B
arm group type: Active Comparator
description: The Capulorhexis and nuclear fragmentation are performed manually.
intervention type: Device
intervention name: Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)
description: Capsulotomy and pre-fragmentation of the nucleus are performed by the femtosecond laser.
arm group label: Group A
intervention type: Device
intervention name: Manual (CCC technique with Utrata forceps)
description: Capsulorhexis and pre-fragmentation are performed manually.
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Soon Phaik Chee, Assoc Prof
role: Principal Investigator
affiliation: Singapore National Eye Center
facility: 
country: Singapore
url: http://www.technolaspv.com/
description: Sponsor
responsible party type: Sponsor
mesh term: Cataract