<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/NCT01712503</url>
  </required_header>
  <id_info>
    <org_study_id>1518/WSHT/2012</org_study_id>
    <nct_id>NCT01712503</nct_id>
  </id_info>
  <brief_title>A Trial of Toric Versus Non-toric Intraocular Lenses in Phacoemulsification Cataract Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Sussex Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rayner Intraocular Lenses Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Western Sussex Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomised controlled trial that formally compares intra-ocular lenses, which can&#xD;
      be used in cataract surgery, one of which is the standard 'monofocal' lens, and the other is&#xD;
      the newer toric lens which can correct astgimatism.&#xD;
&#xD;
      The null hypothesis is that both intra-ocular lenses give the same visual outcome in cataract&#xD;
      surgery. The alternative hypothesis is that the toric lens, provides a better unaided&#xD;
      (without glasses) vision, by correcting the participant's astigmatism.&#xD;
&#xD;
      It has been decided to conduct a randomised controlled trial of the two lenses, as although&#xD;
      the toric lenses are endorsed by many case series (which show a reduction in astigmatism),&#xD;
      they have not been formally compared to the standard lens. An RCT will enable the formal&#xD;
      comparison.&#xD;
&#xD;
      It is expected that this trial will take approximately a year to conduct: six months of&#xD;
      recruitment and six months of follow-up. A further six months will be required to analyse the&#xD;
      data and prepare a manuscript for publication.&#xD;
&#xD;
      The investigators do not plan to conduct an interim analysis or report as this is a&#xD;
      short-trial (six months follow-up) using two alternative lens that are CE marked and already&#xD;
      widely used.&#xD;
&#xD;
      Participants who have both cataract and astigmatism will be identified from the&#xD;
      GP/optometrist referral letter. They will be seen in specially designated clinics for this&#xD;
      research study, which will run alongside the routine cataract 'one' stop clinics at St&#xD;
      Richard's Hospital and Worthing Hospital. This will allow for those patients who wish to be&#xD;
      part of the study to have all the necessary examination done in one visit and for those who&#xD;
      decline participation to be seen in the regular cataract clinic. Potential participants will&#xD;
      be sent the research trial information (appendix A) with their appointment letter.&#xD;
&#xD;
      After introducing himself the researcher (who is also a senior cataract surgeon at Western&#xD;
      Sussex Hospital Trust), will check if potential participants have had the opportunity to read&#xD;
      the trial information that they were sent, or give participants a further copy as required.&#xD;
      The key points of the trial will be re-iterated by the researcher and they will be invited to&#xD;
      ask any questions about the trialThe researcher will check that the potential participant has&#xD;
      read and understood the participant information leaflet. They will answer any questions that&#xD;
      the potential participant has and will then take signed consent from those willing to&#xD;
      participate.&#xD;
&#xD;
      Only one eye (the 'trial eye') from each patient will be used in the trial. In patients with&#xD;
      bilateral cataract, one eye will be selected as the trial eye. This will be the eye that the&#xD;
      participant prefers, after consultation with the researcher or surgeon, to have operated&#xD;
      first. The participant will be allocated a unique study reference number.&#xD;
&#xD;
      Patients who decline to take part in the trial will be offered cataract surgery as per usual&#xD;
      WSHT/NHS procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">January 2014</completion_date>
  <primary_completion_date type="Anticipated">January 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Unaided LogMAR visual acuity at 2 months post-operatively</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unaided LogMAR visual acuity at 2 weeks and 6 months post-operatively</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corrected visual acuity at 2 months and 6 months post-operatively</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual spherical and cylindrical prescriptions at 2 weeks, 2 months and 6 months post-operatively</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients quality of life questionnaire to assess subjective vision, glare at day/night, subjective colour perception, other symptoms.</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Cataract</condition>
  <condition>Astigmatism</condition>
  <arm_group>
    <arm_group_label>Toric intraocular lens</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TFlex Lens (623T)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monofocal intraocular lens</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Superflex Aspheric Lens (920H)/Cflex Aspheric Lens (970C)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Phacoemulsfication cataract surgery and intra-ocular lens implant</intervention_name>
    <arm_group_label>Monofocal intraocular lens</arm_group_label>
    <arm_group_label>Toric intraocular lens</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Symptomatic cataract for which the patient desires surgery&#xD;
&#xD;
          2. Corneal astigmatism of greater than or equal to 2 dioptres&#xD;
&#xD;
          3. No significant ophthalmic comorbidity&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. &lt;18 years of age&#xD;
&#xD;
          2. Significant ophthalmic co-morbidity&#xD;
&#xD;
          3. Pregnant&#xD;
&#xD;
          4. Medically unfit for cataract surgery&#xD;
&#xD;
          5. Not competent to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Masoud Teimory</last_name>
    <email>masoud.teimory@wsht.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Saul Rajak</last_name>
    <email>saul.rajak@lshtm.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Western Sussex Hospital Trust</name>
      <address>
        <city>Worthing and Chichester</city>
        <state>West Sussex</state>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Masoud Teimory</last_name>
      <email>masoud.teimory@wsht.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Saul Rajak</last_name>
      <email>saul.rajak@lshtm.ac.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Masoud Teimory</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pari Shah</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>October 22, 2012</last_update_submitted>
  <last_update_submitted_qc>October 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Sussex Hospitals NHS Trust</investigator_affiliation>
    <investigator_full_name>Mr Masoud Teimory</investigator_full_name>
    <investigator_title>Consultant ophthalmologist and principle investigator</investigator_title>
  </responsible_party>
  <keyword>Cataract</keyword>
  <keyword>Astigmatism</keyword>
  <keyword>Toric</keyword>
  <keyword>Phacoemulsification</keyword>
  <keyword>Intraocular lens</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>
  <!-- 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/NCT01712503
org study id: 1518/WSHT/2012
nct id: NCT01712503
lead sponsor: 
collaborator: 
has dmc: No
This is a randomised controlled trial that formally compares intra-ocular lenses, which can
      be used in cataract surgery, one of which is the standard 'monofocal' lens, and the other is
      the newer toric lens which can correct astgimatism.

      The null hypothesis is that both intra-ocular lenses give the same visual outcome in cataract
      surgery. The alternative hypothesis is that the toric lens, provides a better unaided
      (without glasses) vision, by correcting the participant's astigmatism.

      It has been decided to conduct a randomised controlled trial of the two lenses, as although
      the toric lenses are endorsed by many case series (which show a reduction in astigmatism),
      they have not been formally compared to the standard lens. An RCT will enable the formal
      comparison.

      It is expected that this trial will take approximately a year to conduct: six months of
      recruitment and six months of follow-up. A further six months will be required to analyse the
      data and prepare a manuscript for publication.

      The investigators do not plan to conduct an interim analysis or report as this is a
      short-trial (six months follow-up) using two alternative lens that are CE marked and already
      widely used.

      Participants who have both cataract and astigmatism will be identified from the
      GP/optometrist referral letter. They will be seen in specially designated clinics for this
      research study, which will run alongside the routine cataract 'one' stop clinics at St
      Richard's Hospital and Worthing Hospital. This will allow for those patients who wish to be
      part of the study to have all the necessary examination done in one visit and for those who
      decline participation to be seen in the regular cataract clinic. Potential participants will
      be sent the research trial information (appendix A) with their appointment letter.

      After introducing himself the researcher (who is also a senior cataract surgeon at Western
      Sussex Hospital Trust), will check if potential participants have had the opportunity to read
      the trial information that they were sent, or give participants a further copy as required.
      The key points of the trial will be re-iterated by the researcher and they will be invited to
      ask any questions about the trialThe researcher will check that the potential participant has
      read and understood the participant information leaflet. They will answer any questions that
      the potential participant has and will then take signed consent from those willing to
      participate.

      Only one eye (the 'trial eye') from each patient will be used in the trial. In patients with
      bilateral cataract, one eye will be selected as the trial eye. This will be the eye that the
      participant prefers, after consultation with the researcher or surgeon, to have operated
      first. The participant will be allocated a unique study reference number.

      Patients who decline to take part in the trial will be offered cataract surgery as per usual
      WSHT/NHS procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Unaided LogMAR visual acuity at 2 months post-operatively
measure: Unaided LogMAR visual acuity at 2 weeks and 6 months post-operatively
measure: Corrected visual acuity at 2 months and 6 months post-operatively
measure: Residual spherical and cylindrical prescriptions at 2 weeks, 2 months and 6 months post-operatively
measure: Patients quality of life questionnaire to assess subjective vision, glare at day/night, subjective colour perception, other symptoms.
arm group label: Toric intraocular lens
arm group type: Experimental
description: TFlex Lens (623T)
arm group label: Monofocal intraocular lens
arm group type: Placebo Comparator
description: Superflex Aspheric Lens (920H)/Cflex Aspheric Lens (970C)
intervention type: Device
intervention name: Phacoemulsfication cataract surgery and intra-ocular lens implant
arm group label: Monofocal intraocular lens
arm group label: Toric intraocular lens
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Masoud Teimory
email: masoud.teimory@wsht.nhs.uk
last name: Saul Rajak
email: saul.rajak@lshtm.ac.uk
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Western Sussex Hospitals NHS Trust
investigator full name: Mr Masoud Teimory
investigator title: Consultant ophthalmologist and principle investigator
mesh term: Cataract
mesh term: Astigmatism