<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/NCT03819842</url>
  </required_header>
  <id_info>
    <org_study_id>SSM--2017-12</org_study_id>
    <nct_id>NCT03819842</nct_id>
  </id_info>
  <brief_title>Evaluating the Need for the Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation</brief_title>
  <official_title>Evaluating the Need for Pseudophakic Intraoperative Abberrometry in Toric IOL Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alterman, Modi, &amp; Wolter Ophthalmic Physicians &amp; Surgeons</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alterman, Modi, &amp; Wolter Ophthalmic Physicians &amp; Surgeons</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine clinically significant difference in results obtained from cataract surgery&#xD;
      using IA. One eye will receive aphakic measurements only and the fellow eye will receive&#xD;
      aphakic and then pseudophakic measurements when implanting a toric IOL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine if there is a clinically significant difference in the results obtained for the&#xD;
      toric IOL implantation when using IA to measure the aphakic eye only and when using IA to&#xD;
      measure the aphakic eye and then the pseudophakic eye, with toric IOL implantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 19, 2018</start_date>
  <completion_date type="Actual">January 14, 2019</completion_date>
  <primary_completion_date type="Actual">January 14, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinically significant difference in results obtained for tori iol implantation when using IA</measure>
    <time_frame>30 days</time_frame>
    <description>Difference in magnitude of residual refractive astigmatism between groups Percentage of eyes with 0.50D or less of postoperative residual refractive astigmatism at 1 month post-op in each sub-group&#xD;
Percentage of eyes within 0.50D of intended spherical equivalent&#xD;
Sub-group analysis:&#xD;
Vector analysis of the effects of any toric IOL realignment suggested by pseudophakic IA (i.e. was it likely to improve or worsen residual refractive astigmatism and/or UCVA)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Cataract</condition>
  <condition>Nuclear Sclerosis</condition>
  <condition>Cortical Cataract</condition>
  <condition>Posterior Subcapsular Cataract</condition>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>Aphakic Measure only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Eye measured in aphakic state only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pseudophakic measure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eye measured in aphakic state then again in pseudophakic state with toric IOL using the ORA System. Pseudophakic measurement obtained will provide data about placement of toric iol and the surgeon will use that data to rotate the iol if necessary.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pseudophakic Measurement</intervention_name>
    <description>standard aphakic measurements will be taken and then pseudophakic measurements will be taken after toric iol implantation. The data produced will aid the surgeon in proper placement of toric iol orientation</description>
    <arm_group_label>Pseudophakic measure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willing and able to understand and sign an informed consent&#xD;
&#xD;
          -  willing and able to attend all study visits&#xD;
&#xD;
          -  presenting for uncomplicated bilateral cataract surgery and have an interest in a&#xD;
             toric iol&#xD;
&#xD;
          -  have good ocular health, with no pathology that compromises visual acuity (outside of&#xD;
             residual refractive error)&#xD;
&#xD;
          -  have visually significant cataracts&#xD;
&#xD;
          -  have regular corneal astigmatism of 1.0D to 5.0D in both eyes with a difference&#xD;
             between eyes of 1.0D or less&#xD;
&#xD;
          -  have potential post operative acuity of 20/25 or better&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  corneal pathology&#xD;
&#xD;
          -  amblyopia&#xD;
&#xD;
          -  prior corneal refractive surgery or other refractive surgery&#xD;
&#xD;
          -  previous anterior or posterior chamber surgery that the investigator feels may&#xD;
             compromise visual outcomes&#xD;
&#xD;
          -  Diabetic retinopathy if the investigator feels this will compromise visual outcomes&#xD;
&#xD;
          -  macular degeneration&#xD;
&#xD;
          -  history of retinal detachment&#xD;
&#xD;
          -  irregular astigmatism or keratoconus&#xD;
&#xD;
          -  strabismus&#xD;
&#xD;
          -  if in the surgeon's opinion the subject is not an appropriate candidate for iol&#xD;
             implantation&#xD;
&#xD;
          -  subjects who have an acute or chronic disease or illness that would confound the&#xD;
             results of this investigation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Alterman Modi and Wolter Ophthalmic Physicians and Surgeons</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 5, 2022</last_update_submitted>
  <last_update_submitted_qc>January 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cataract surgery</keyword>
  <keyword>cataract</keyword>
  <keyword>toric IOL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Astigmatism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Results of the study may be shared at international meetings and submitted for peer review</ipd_description>
  </patient_data>
  <!-- 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/NCT03819842
org study id: SSM--2017-12
nct id: NCT03819842
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To determine clinically significant difference in results obtained from cataract surgery
      using IA. One eye will receive aphakic measurements only and the fellow eye will receive
      aphakic and then pseudophakic measurements when implanting a toric IOL.
To determine if there is a clinically significant difference in the results obtained for the
      toric IOL implantation when using IA to measure the aphakic eye only and when using IA to
      measure the aphakic eye and then the pseudophakic eye, with toric IOL implantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinically significant difference in results obtained for tori iol implantation when using IA
time frame: 30 days
description: Difference in magnitude of residual refractive astigmatism between groups Percentage of eyes with 0.50D or less of postoperative residual refractive astigmatism at 1 month post-op in each sub-group
Percentage of eyes within 0.50D of intended spherical equivalent
Sub-group analysis:
Vector analysis of the effects of any toric IOL realignment suggested by pseudophakic IA (i.e. was it likely to improve or worsen residual refractive astigmatism and/or UCVA)
arm group label: Aphakic Measure only
arm group type: No Intervention
description: Eye measured in aphakic state only
arm group label: Pseudophakic measure
arm group type: Active Comparator
description: Eye measured in aphakic state then again in pseudophakic state with toric IOL using the ORA System. Pseudophakic measurement obtained will provide data about placement of toric iol and the surgeon will use that data to rotate the iol if necessary.
intervention type: Diagnostic Test
intervention name: Pseudophakic Measurement
description: standard aphakic measurements will be taken and then pseudophakic measurements will be taken after toric iol implantation. The data produced will aid the surgeon in proper placement of toric iol orientation
arm group label: Pseudophakic measure
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Astigmatism
sharing ipd: Undecided
ipd description: Results of the study may be shared at international meetings and submitted for peer review