<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/NCT02264457</url>
  </required_header>
  <id_info>
    <org_study_id>IISR-2014-003</org_study_id>
    <nct_id>NCT02264457</nct_id>
  </id_info>
  <brief_title>A Intra-patient Comparison of Closed Loop and Plate Haptic Toric Intraocular Lenses</brief_title>
  <official_title>A Randomised Intra-patient Comparison of Closed Loop and Plate Haptic Toric, Aspheric, Aberration Neutral, Hydrophilic Acrylic Intraocular Lenses in Patients With Bilateral Astigmatism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Plymouth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BMI Southend Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Plymouth</source>
  <brief_summary>
    <textblock>
      During cataract surgery an artificial lens is implanted in the eye. These artificial lenses&#xD;
      are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your&#xD;
      eyes have astigmatism, which is a normal and common characteristic of the eye. If left&#xD;
      uncorrected the astigmatism would mean that you would need to wear spectacles for viewing&#xD;
      distance objects. New IOL designs called toric IOLs help to correct the astigmatism to&#xD;
      improve your vision after cataract surgery. This study has been designed to look at how well&#xD;
      a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing&#xD;
      distance objects. There are many designs of these toric IOLs and for this study we are&#xD;
      looking to compare two different designs of toric IOLs by putting one lens in your right eye&#xD;
      and a different type of lens in your left eye. Both lenses are commercially available and are&#xD;
      commonly implanted IOLs. Using new non-invasive methods we hope to be able to better judge&#xD;
      the visual performance of these lenses and the ability of these lenses to correct&#xD;
      astigmatism. In addition the study will involve imaging and examining the IOLs to determine&#xD;
      the prevalence of any post-operative complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Best-corrected visual acuity</measure>
    <time_frame>Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Manifest refraction</measure>
    <time_frame>Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotational stability</measure>
    <time_frame>Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IOL centration</measure>
    <time_frame>Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of posterior capsular Opacification</measure>
    <time_frame>visit 4 (3-4 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>First eye closed loop haptic</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>subjects implanted with the Closed loop haptic during first eye surgery and the plate haptics toric intraocular lens during second eye surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>First eye plate haptic</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>subjects implanted with the plate haptic toric during first eye surgery and the closed loop haptic toric intraocular lens during second eye surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>T-flex Aspheric Toric IOL</intervention_name>
    <arm_group_label>First eye closed loop haptic</arm_group_label>
    <arm_group_label>First eye plate haptic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AT TORBI toric IOL</intervention_name>
    <arm_group_label>First eye closed loop haptic</arm_group_label>
    <arm_group_label>First eye plate haptic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 50-75 years, bilateral significant corneal astigmatism &gt;1.50D.&#xD;
&#xD;
          -  Requiring a Toric IOL within the following power range:&#xD;
&#xD;
          -  Sphere +6.00D to +30.00D&#xD;
&#xD;
          -  Cylinder +1.00D to +6.00D&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Amblyopia,&#xD;
&#xD;
          -  predicted bilateral post-op corneal astigmatism of &lt;1.50D,&#xD;
&#xD;
          -  irregular astigmatism,&#xD;
&#xD;
          -  dilated pupil size smaller than 5mm,&#xD;
&#xD;
          -  macular pathology,&#xD;
&#xD;
          -  glaucoma,&#xD;
&#xD;
          -  retinal disease,&#xD;
&#xD;
          -  corneal disease,&#xD;
&#xD;
          -  abnormal iris,&#xD;
&#xD;
          -  pupil deformation and&#xD;
&#xD;
          -  any previous corneal or intraocular surgery.&#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>Phillip J Buckhurst, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Plymouth University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Phillip J Buckhurst, PhD</last_name>
    <phone>+44 (0) 1752 588884</phone>
    <email>phillip.buckhurst@plymouth.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>BMI Southend Private Hospital</name>
      <address>
        <city>Westcliff on Sea</city>
        <state>Essex</state>
        <zip>SS09AG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maralyn Cole</last_name>
      <phone>01702 608908</phone>
      <email>Maralyn.Cole@bmihealthcare.co.uk</email>
    </contact>
    <contact_backup>
      <last_name>Elizabeth Law, BSc(hons)</last_name>
      <email>elizabeth.law@plymouth.ac.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Plymouth</investigator_affiliation>
    <investigator_full_name>Dr Phillip J Buckhurst</investigator_full_name>
    <investigator_title>Associate Professor (Senior Lecturer)</investigator_title>
  </responsible_party>
  <keyword>Lenses, Intraocular</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/NCT02264457
org study id: IISR-2014-003
nct id: NCT02264457
lead sponsor: 
collaborator: 
During cataract surgery an artificial lens is implanted in the eye. These artificial lenses
      are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your
      eyes have astigmatism, which is a normal and common characteristic of the eye. If left
      uncorrected the astigmatism would mean that you would need to wear spectacles for viewing
      distance objects. New IOL designs called toric IOLs help to correct the astigmatism to
      improve your vision after cataract surgery. This study has been designed to look at how well
      a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing
      distance objects. There are many designs of these toric IOLs and for this study we are
      looking to compare two different designs of toric IOLs by putting one lens in your right eye
      and a different type of lens in your left eye. Both lenses are commercially available and are
      commonly implanted IOLs. Using new non-invasive methods we hope to be able to better judge
      the visual performance of these lenses and the ability of these lenses to correct
      astigmatism. In addition the study will involve imaging and examining the IOLs to determine
      the prevalence of any post-operative complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Best-corrected visual acuity
time frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months
measure: Manifest refraction
time frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
measure: Rotational stability
time frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
measure: IOL centration
time frame: Visit 1 (1-2 days post implantation), visit 2 (1-2 weeks post implantation), visit 3 (1-2 months post implantation) and visit 4 (3-4 months)
measure: Prevalence of posterior capsular Opacification
time frame: visit 4 (3-4 months)
arm group label: First eye closed loop haptic
arm group type: Other
description: subjects implanted with the Closed loop haptic during first eye surgery and the plate haptics toric intraocular lens during second eye surgery
arm group label: First eye plate haptic
arm group type: Other
description: subjects implanted with the plate haptic toric during first eye surgery and the closed loop haptic toric intraocular lens during second eye surgery
intervention type: Device
intervention name: T-flex Aspheric Toric IOL
arm group label: First eye closed loop haptic
arm group label: First eye plate haptic
intervention type: Device
intervention name: AT TORBI toric IOL
arm group label: First eye closed loop haptic
arm group label: First eye plate haptic
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Phillip J Buckhurst, PhD
role: Principal Investigator
affiliation: Plymouth University
last name: Phillip J Buckhurst, PhD
phone: +44 (0) 1752 588884
email: phillip.buckhurst@plymouth.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Plymouth
investigator full name: Dr Phillip J Buckhurst
investigator title: Associate Professor (Senior Lecturer)
mesh term: Cataract