xml: <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/NCT05968547</url>
    </required_header>
    <id_info>
      <org_study_id>B00964</org_study_id>
      <nct_id>NCT05968547</nct_id>
    </id_info>
    <brief_title>Evaluation of Patients' Requirements for Improved Advice and Guidance on Vision Standards for Driving in Glaucoma</brief_title>
    <acronym>D&amp;G</acronym>
    <official_title>Evaluation of Patients' Requirements for Improved Advice and Guidance on Vision Standards for Driving in Glaucoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Manchester University NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Manchester University NHS Foundation Trust</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Glaucoma can affect both central and peripheral vision. Clinicians need to discuss with&#xD;
        patients the vision related driving standards and any specific limitations their patients may&#xD;
        have relating to their ability to drive with glaucoma. According to the recent guidelines by&#xD;
        the General Optical Council (GOC), clinicians are advised to make sure that the Driving and&#xD;
        Vehicle Licensing Agency (DVLA) is informed about patients who do not meet the driving vision&#xD;
        standards. There are several limitations in making a professional judgement about a patient's&#xD;
        suitability to drive and in providing appropriate advice to patients. The main concern is&#xD;
        discussing this sensitive issue with the patient based upon available clinical evidence e.g.&#xD;
        vision or visual field and directing them to inform the DVLA of their condition or&#xD;
        potentially advising them to stop driving. The purpose of this research is to investigate the&#xD;
        two main issues 1. To explore patients' understanding of standards of vision for driving. 2.&#xD;
        Comparing the standards of vision for driving estimated in the clinic with number plate&#xD;
        vision. We propose to do a mixed methods analysis using a patient survey and quantitative&#xD;
        investigation of driving vision standards.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The two main objectives that we propose to study in this project are&#xD;
  &#xD;
          1. Descriptive understanding of patients' perception of their driving needs and their&#xD;
             understanding of driving standards. This will be studied with the help of a survey&#xD;
             questionnaire to learn about patients' driving needs, sight history, understanding of&#xD;
             DVLA vision standards and the driving advice given to them. Understanding glaucoma&#xD;
             patients' general perceptions about standards of vision for driving and their driving&#xD;
             needs will help us to improve communication with the patients and to give the best&#xD;
             possible advice about standards of vision for driving.&#xD;
  &#xD;
          2. Quantitative comparison of standards of vision for driving as required by DVLA and&#xD;
             clinical vision assessment in glaucoma patients. The limitations to meet the vision&#xD;
             standard for driving will be assessed in glaucoma patients in the clinic and outside the&#xD;
             clinic as required by DVLA standards of vision for driving. In the clinic, vision will&#xD;
             be assessed by checking if the patient can binocularly read the 6/12 line on the vision&#xD;
             chart and electronic number plate test used in the clinic. The results will be compared&#xD;
             with a self-assessed number plate vision - a standard requirement to meet DVLA's&#xD;
             standard of vision for driving. Understanding the clinical estimation of binocular&#xD;
             vision, patients' ability to read the number plate in clinic and to self-assess their&#xD;
             number plate vision will help the clinician to know patients' abilities and give&#xD;
             evidence-based advice to the glaucoma patient about meeting the DVLA standards of&#xD;
             vision.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 25, 2023</start_date>
    <completion_date type="Anticipated">December 25, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 25, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Ability to read 6/12 or above in vision chart with both eyes.</measure>
      <time_frame>6 months</time_frame>
      <description>Binocular Vision assessment in Logmar testing</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vision Chart score in each eye</measure>
      <time_frame>6 months</time_frame>
      <description>Unilateral Vision testing Logmar testing</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ability to read the number plate in the clinic displayed in the VDU</measure>
      <time_frame>6 months</time_frame>
      <description>Ability to read the number plate in the clinic displayed in the VDU comparative visual display unit</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ability to read the car number plate outside the clinic</measure>
      <time_frame>6 months</time_frame>
      <description>Ability to read the car number plate outside the clinic as per patients self assessment</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Glaucoma</condition>
    <arm_group>
      <arm_group_label>Glaucoma patients questionnaire</arm_group_label>
      <description>Questionnaire to understand patients driving needs and understanding of driving vision standards</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Visual acuity standards</arm_group_label>
      <description>DVLA vision standard estimated in the clinic is compared with standandard car number plate outside the clinic. We estimate the vision in the clinic using standard visual acuity chart and electronic number plate vision and compare with number plate vision estimated outside the clinic by the patient. Instruction to estimate number plate vision will be provided to the patient.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Driving assessment in glaucoma patient</intervention_name>
      <description>One group of patient will be given questionnaire while the other group will respond to a questionnaire while the other group will have vision assessment. Patients could participate in both groups.</description>
      <arm_group_label>Visual acuity standards</arm_group_label>
      <other_name>1. questionnaire to patient. 2.Assessment of vision using visual acuity chart and number plate vision</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients attending glaucoma clinics.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria for Patient survey:&#xD;
  &#xD;
            -  All patients attending the glaucoma clinic will be eligible for the survey.&#xD;
  &#xD;
            -  Both drivers and non-drivers will be included in the study.&#xD;
  &#xD;
          Inclusion Criteria for Quantitative vision estimation:&#xD;
  &#xD;
          • Glaucoma patients with habitual vision of 6/19 or better at least in one eye (whether&#xD;
          driving or not driving).&#xD;
  &#xD;
          Exclusion criteria for Patient survey:&#xD;
  &#xD;
          • All the patients attending glaucoma clinic, willing to participate in the study, will be&#xD;
          eligible to participate in the survey and will not be excluded from the study.&#xD;
  &#xD;
          Exclusion Criteria for Quantitative vision estimation:&#xD;
  &#xD;
          • Patients with a binocular habitual visual acuity of less than 6/19 will not be able to&#xD;
          eligible to participate in qualitative vision assessment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>110 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Subash Sukumar</last_name>
      <role>Principal Investigator</role>
      <affiliation>Manchester Royal Eye Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Subash Sukumar</last_name>
      <phone>0161-276-6583</phone>
      <email>subash.sukumar@mft.nhs.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Subash Sukumar</last_name>
      <phone>01612766583</phone>
      <email>subash.sukumar@mft.nhs.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Manchester Royal Eye Hospital</name>
        <address>
          <city>Manchester</city>
          <zip>M13 9WH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Subash Sukumar</last_name>
        <phone>01612766583</phone>
        <email>subash.sukumar@mft.nhs.uk</email>
      </contact>
      <investigator>
        <last_name>Subash Sukumar</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Driving Standards</keyword>
    <keyword>DVLA</keyword>
    <keyword>Glaucoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glaucoma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968547
  org study id: B00964
  nct id: NCT05968547
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Glaucoma can affect both central and peripheral vision. Clinicians need to discuss with
        patients the vision related driving standards and any specific limitations their patients may
        have relating to their ability to drive with glaucoma. According to the recent guidelines by
        the General Optical Council (GOC), clinicians are advised to make sure that the Driving and
        Vehicle Licensing Agency (DVLA) is informed about patients who do not meet the driving vision
        standards. There are several limitations in making a professional judgement about a patient's
        suitability to drive and in providing appropriate advice to patients. The main concern is
        discussing this sensitive issue with the patient based upon available clinical evidence e.g.
        vision or visual field and directing them to inform the DVLA of their condition or
        potentially advising them to stop driving. The purpose of this research is to investigate the
        two main issues 1. To explore patients' understanding of standards of vision for driving. 2.
        Comparing the standards of vision for driving estimated in the clinic with number plate
        vision. We propose to do a mixed methods analysis using a patient survey and quantitative
        investigation of driving vision standards.
  The two main objectives that we propose to study in this project are
  
          1. Descriptive understanding of patients' perception of their driving needs and their
             understanding of driving standards. This will be studied with the help of a survey
             questionnaire to learn about patients' driving needs, sight history, understanding of
             DVLA vision standards and the driving advice given to them. Understanding glaucoma
             patients' general perceptions about standards of vision for driving and their driving
             needs will help us to improve communication with the patients and to give the best
             possible advice about standards of vision for driving.
  
          2. Quantitative comparison of standards of vision for driving as required by DVLA and
             clinical vision assessment in glaucoma patients. The limitations to meet the vision
             standard for driving will be assessed in glaucoma patients in the clinic and outside the
             clinic as required by DVLA standards of vision for driving. In the clinic, vision will
             be assessed by checking if the patient can binocularly read the 6/12 line on the vision
             chart and electronic number plate test used in the clinic. The results will be compared
             with a self-assessed number plate vision - a standard requirement to meet DVLA's
             standard of vision for driving. Understanding the clinical estimation of binocular
             vision, patients' ability to read the number plate in clinic and to self-assess their
             number plate vision will help the clinician to know patients' abilities and give
             evidence-based advice to the glaucoma patient about meeting the DVLA standards of
             vision.
  observational model: Cohort
  time perspective: Prospective
  measure: Ability to read 6/12 or above in vision chart with both eyes.
  time frame: 6 months
  description: Binocular Vision assessment in Logmar testing
  measure: Vision Chart score in each eye
  time frame: 6 months
  description: Unilateral Vision testing Logmar testing
  measure: Ability to read the number plate in the clinic displayed in the VDU
  time frame: 6 months
  description: Ability to read the number plate in the clinic displayed in the VDU comparative visual display unit
  measure: Ability to read the car number plate outside the clinic
  time frame: 6 months
  description: Ability to read the car number plate outside the clinic as per patients self assessment
  arm group label: Glaucoma patients questionnaire
  description: Questionnaire to understand patients driving needs and understanding of driving vision standards
  arm group label: Visual acuity standards
  description: DVLA vision standard estimated in the clinic is compared with standandard car number plate outside the clinic. We estimate the vision in the clinic using standard visual acuity chart and electronic number plate vision and compare with number plate vision estimated outside the clinic by the patient. Instruction to estimate number plate vision will be provided to the patient.
  intervention type: Other
  intervention name: Driving assessment in glaucoma patient
  description: One group of patient will be given questionnaire while the other group will respond to a questionnaire while the other group will have vision assessment. Patients could participate in both groups.
  arm group label: Visual acuity standards
  other name: 1. questionnaire to patient. 2.Assessment of vision using visual acuity chart and number plate vision
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 110 Years
  healthy volunteers: No
  last name: Subash Sukumar
  role: Principal Investigator
  affiliation: Manchester Royal Eye Hospital
  last name: Subash Sukumar
  phone: 0161-276-6583
  email: subash.sukumar@mft.nhs.uk
  last name: Subash Sukumar
  phone: 01612766583
  email: subash.sukumar@mft.nhs.uk
  facility: 
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Glaucoma