<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/NCT03819582</url>
  </required_header>
  <id_info>
    <org_study_id>17/WM/0181</org_study_id>
    <nct_id>NCT03819582</nct_id>
  </id_info>
  <brief_title>Visual Performance With a Hydrophobic Aspheric Monofocal IOL</brief_title>
  <official_title>Visual Performance Following Implantation of a Hydrophobic Aspheric Monofocal Intraocular Lens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Plymouth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Plymouth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the&#xD;
      natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal&#xD;
      IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide&#xD;
      excellent distance vision, however spectacles are required for reading and intermediate&#xD;
      distance tasks. Monofocal Intraocular lenses are the mainstay of cataract surgery, but with&#xD;
      advancing technologies and a wider selection of lenses available, demand for improved&#xD;
      outcomes, improved lens design and ease of surgical implantation have increased. The purpose&#xD;
      of this study is to assess the visual performance of the EyeCee One monofocal intraocular&#xD;
      lens. In addition an assessment of the ease of insertion by the surgeon will be quantified.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the&#xD;
      natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal&#xD;
      IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide&#xD;
      excellent distance vision, however spectacles are required for reading and intermediate&#xD;
      distance tasks. There are many different designs of monofocal IOLs, all with their own unique&#xD;
      optical properties, however there is little evidence to support which optical design provides&#xD;
      the best visual outcome. This research project allows us to assess the visual outcomes of a&#xD;
      specific monofocal IOL. It also allows us to assess the ease of use of the lens to the&#xD;
      surgeon.&#xD;
&#xD;
      Each subject will be evaluated at two visits following IOL implantation; visit 1 (1 month&#xD;
      post implantation), Visit 2 (3 months post implantation).&#xD;
&#xD;
      At both post-operative visits the patient will undergo:&#xD;
&#xD;
      Refraction Uncorrected and best corrected distance and near visual acuity measurement Optical&#xD;
      biometry to assess ELP Slit lamp biomicroscopy to assess for post-operative complications&#xD;
&#xD;
      At the time of surgery, the ophthalmic surgeon will complete a questionnaire, detailing lens&#xD;
      insertion time and ease of use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">January 1, 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual acuity early post operative</measure>
    <time_frame>1 month post operatively</time_frame>
    <description>Visual acuity measured in LogMAR early post operatively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual acuity after 3 months post operatively</measure>
    <time_frame>3 months post operatively</time_frame>
    <description>Visual acuity measured in LogMAR measured 3 months post operatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of use to surgeons</measure>
    <time_frame>During surgery</time_frame>
    <description>Questionnaire completed by the surgeon to determine the usability of the intraocular lens</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Intraocular lens</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects implanted with the EyeCee One Intraocular lens</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EyeCee One intraocular lens</intervention_name>
    <description>Hydrophobic aspheric monofocal intraocular lens</description>
    <arm_group_label>Intraocular lens</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Clinically significant Cataract requiring cataract surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Amblyopia&#xD;
&#xD;
          -  Corneal astigmatism of &gt;1.00D&#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&#xD;
&#xD;
          -  Any previous corneal or intraocular surgery&#xD;
&#xD;
          -  Any patient who had surgical complications will also be excluded from participation in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Phillip Buckhurst</last_name>
    <phone>07825429121</phone>
    <email>phillip.buckhurst@plymouth.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>BMI Southend Hospital</name>
      <address>
        <city>Westcliff-on-Sea</city>
        <state>Essex</state>
        <zip>SS0 9AG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Law</last_name>
      <email>elizabeth.law@plymouth.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</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 28, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 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 Head of School for Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03819582
org study id: 17/WM/0181
nct id: NCT03819582
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the
      natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal
      IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide
      excellent distance vision, however spectacles are required for reading and intermediate
      distance tasks. Monofocal Intraocular lenses are the mainstay of cataract surgery, but with
      advancing technologies and a wider selection of lenses available, demand for improved
      outcomes, improved lens design and ease of surgical implantation have increased. The purpose
      of this study is to assess the visual performance of the EyeCee One monofocal intraocular
      lens. In addition an assessment of the ease of insertion by the surgeon will be quantified.
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the
      natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal
      IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide
      excellent distance vision, however spectacles are required for reading and intermediate
      distance tasks. There are many different designs of monofocal IOLs, all with their own unique
      optical properties, however there is little evidence to support which optical design provides
      the best visual outcome. This research project allows us to assess the visual outcomes of a
      specific monofocal IOL. It also allows us to assess the ease of use of the lens to the
      surgeon.

      Each subject will be evaluated at two visits following IOL implantation; visit 1 (1 month
      post implantation), Visit 2 (3 months post implantation).

      At both post-operative visits the patient will undergo:

      Refraction Uncorrected and best corrected distance and near visual acuity measurement Optical
      biometry to assess ELP Slit lamp biomicroscopy to assess for post-operative complications

      At the time of surgery, the ophthalmic surgeon will complete a questionnaire, detailing lens
      insertion time and ease of use.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual acuity early post operative
time frame: 1 month post operatively
description: Visual acuity measured in LogMAR early post operatively
measure: Visual acuity after 3 months post operatively
time frame: 3 months post operatively
description: Visual acuity measured in LogMAR measured 3 months post operatively
measure: Ease of use to surgeons
time frame: During surgery
description: Questionnaire completed by the surgeon to determine the usability of the intraocular lens
arm group label: Intraocular lens
arm group type: Experimental
description: Subjects implanted with the EyeCee One Intraocular lens
intervention type: Device
intervention name: EyeCee One intraocular lens
description: Hydrophobic aspheric monofocal intraocular lens
arm group label: Intraocular lens
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
last name: Phillip Buckhurst
phone: 07825429121
email: phillip.buckhurst@plymouth.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Plymouth
investigator full name: Dr Phillip J Buckhurst
investigator title: Associate Head of School for Research
mesh term: Cataract
sharing ipd: No