<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/NCT03823092</url>
  </required_header>
  <id_info>
    <org_study_id>17/WA/0180</org_study_id>
    <nct_id>NCT03823092</nct_id>
  </id_info>
  <brief_title>Polarization Perception in Health and Disease. Testing a New Sight Test</brief_title>
  <acronym>TaNSiT</acronym>
  <official_title>Polarization Perception in Health and Disease. Testing a New Sight Test: The TaNSiT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>South Warwickshire NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>South Warwickshire NHS Foundation Trust</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>
      A study to assess the utility of human polarization pattern perception for the detection,&#xD;
      diagnosis and monitoring of eye disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The recently described high sensitivity of the human eye to differentiate small angular&#xD;
      differences in linear polarization and evidence supporting its macular origin (Misson,&#xD;
      Anderson; 2017) suggests that human polarization sensitivity might be a useful diagnostic&#xD;
      tool for macular disease. This augments a previous study in which we demonstrated the ability&#xD;
      of the human visual system to detect isochromatic isoluminant polarization modulated pattern&#xD;
      stimuli (Misson et al 2015).&#xD;
&#xD;
      This is an exploratory 'proof-of-concept' study to determine the clinical value of&#xD;
      polarization pattern perception, PPP, in health and disease. We further propose that PPP&#xD;
      might be valuable for the diagnosis, monitoring and early detection of macular disease. The&#xD;
      latter includes common blinding conditions such as age related macular degeneration and&#xD;
      diabetic retinopathy. It is also intended to investigate the effect of cataracts and cataract&#xD;
      surgery on PPP: cataract surgery modifies the optics of the eye so might also modify PPP.&#xD;
&#xD;
      PPP is measured using a modification of the methodology described in (Misson et al 2015) and&#xD;
      (Misson, Anderson; 2017) whereby polarization modulated patterns are presented on a modified&#xD;
      LCD display. The observer's task is to report if they see an image and to describe the image.&#xD;
      Images comprise simple patterns or traditional optotypes. A standard set of images are&#xD;
      presented in pseudorandom order and the response recorded. A total score, the polarization&#xD;
      pattern perception score PPP is then determined from the number of images seen/identified. A&#xD;
      more refined metric, the polarization visual acuity pVA, will be derived from the response to&#xD;
      the optotype stimuli. These data are then compared to conventional tests of visual structure&#xD;
      and function including logMAR visual acuity, ocular examination and OCT scan data.&#xD;
&#xD;
      The study in anticipated to comprise:&#xD;
&#xD;
      Phase 1. Normative Evaluation: observational prospective cross-sectional.. A preliminary&#xD;
      normative study will be undertaken on staff members. The aim is to quantify normative values&#xD;
      in preparation for the clinical studies.&#xD;
&#xD;
      Hypotheses to be tested:&#xD;
&#xD;
        1. that healthy subjects can perceive polarization stimuli&#xD;
&#xD;
        2. that there is a threshold of polarization image resolution (pVA) analogous to visual&#xD;
           acuity. Normative PPP and pVA data will be collected.&#xD;
&#xD;
      Phase 2 Patient Group: observational Prospective cross-sectional / case-control.&#xD;
&#xD;
      Phase 2 subjects will comprise normals and patients with cataracts/pseudophakia and/or AMD,&#xD;
      other macular pathology, diabetic retinopathy..&#xD;
&#xD;
      The aim of this phase is to determine the effect, if any, of particular eye conditions on&#xD;
      pVA/PPP alone and in comparison with other test parameters.&#xD;
&#xD;
      Hypotheses to be tested:&#xD;
&#xD;
        1. that eye conditions affect pVA/PPP&#xD;
&#xD;
        2. that specific eye conditions have a selective effect on pVA/PPP&#xD;
&#xD;
        3. that pseudophakia affects pVA/PPP&#xD;
&#xD;
      Phase 3: Cataract pre-op v post op pVA/PPP: prospective interventional case-control.&#xD;
&#xD;
      Timescale:concurrent with Phase 2 A subset of the phase 2 cataract patients will undergo&#xD;
      cataract surgery according to clinical need. These patients are routinely reviewed 4 - 8&#xD;
      weeks post-op when the opportunity will arise to repeat pVA/PPP measurement. The fellow eye&#xD;
      will serve as a control / provide data for repeatability assessment.&#xD;
&#xD;
      The aims of this phase are&#xD;
&#xD;
        1. to determine the repeatability of pVA/PPP testing in a heterogeneous patient group&#xD;
&#xD;
        2. to determine the effect of cataract surgery on the pre-operative pVA/PPP results&#xD;
&#xD;
        3. to determine if pVA/PPP is a useful determinant of post-operative visual outcome.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. that pVA/PPP testing is repeatable&#xD;
&#xD;
        2. that there is a difference in pVA/PPP pre and post cataract surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 9, 2017</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>polarization sensitivity</measure>
    <time_frame>18 month</time_frame>
    <description>determine and compare polarization sensitivity between groups</description>
  </primary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Cataract</condition>
  <condition>Age Related Macular Degeneration</condition>
  <condition>Pseudophakia</condition>
  <condition>Macular Disease</condition>
  <condition>Diabetic Retinopathy</condition>
  <condition>Retinal Disease</condition>
  <arm_group>
    <arm_group_label>Normal</arm_group_label>
    <description>phakic participants with no evidence of eye disorders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cataract</arm_group_label>
    <description>participants with cataract</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AMD</arm_group_label>
    <description>participants with age related macular degeneration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pseudophakic</arm_group_label>
    <description>particpiants who have had cataract surgery with intraocular lens implant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>other macula</arm_group_label>
    <description>participants with macular ddisorders other than AMD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DR</arm_group_label>
    <description>participants with diabetic retinopathy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>polarization sensitivity</intervention_name>
    <description>test of polarization vision as described in Study Description</description>
    <arm_group_label>AMD</arm_group_label>
    <arm_group_label>Cataract</arm_group_label>
    <arm_group_label>DR</arm_group_label>
    <arm_group_label>Normal</arm_group_label>
    <arm_group_label>Pseudophakic</arm_group_label>
    <arm_group_label>other macula</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients and staff of the Eye Department of South Warwickshire NHS Trust&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - willing and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unwilling or unable to provide informed consent&#xD;
&#xD;
          -  individuals wishing to exit the study&#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>Gary P Misson, PhD FRCOphth</last_name>
    <phone>+44 01926495321</phone>
    <email>gary.misson@swft.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jo Williams</last_name>
    <phone>+44 01926495321</phone>
    <email>jo.williams@swft.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>South Warwickshire NHS Foundation Trust</name>
      <address>
        <city>Warwick</city>
        <state>Warwickshire</state>
        <zip>CV37 0PZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gary P Misson, PhD FRCOphth</last_name>
      <phone>+44 01926495321</phone>
      <email>gary.misson@swft.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Jo Williams</last_name>
      <phone>+44 01926495321</phone>
      <email>jo.williams@swft.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Stephen J Anderson, PhD FRCOptom</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Misson GP, Timmerman BH, Bryanston-Cross PJ. Human perception of visual stimuli modulated by direction of linear polarization. Vision Res. 2015 Oct;115(Pt A):48-57. doi: 10.1016/j.visres.2015.08.004. Epub 2015 Aug 28.</citation>
    <PMID>26291073</PMID>
  </results_reference>
  <results_reference>
    <citation>Misson GP, Anderson SJ. The spectral, spatial and contrast sensitivity of human polarization pattern perception. Sci Rep. 2017 Nov 29;7(1):16571. doi: 10.1038/s41598-017-16873-6.</citation>
    <PMID>29185499</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>South Warwickshire NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Gary Misson</investigator_full_name>
    <investigator_title>Consultant ophthalmologist</investigator_title>
  </responsible_party>
  <keyword>macular function</keyword>
  <keyword>polarization perception</keyword>
  <keyword>Haidinger's brush</keyword>
  <keyword>vision testing</keyword>
  <keyword>cataract</keyword>
  <keyword>age related macular degeneration</keyword>
  <keyword>pseudophakia</keyword>
  <keyword>macular disease</keyword>
  <keyword>retinal disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
    <mesh_term>Pseudophakia</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/NCT03823092
org study id: 17/WA/0180
nct id: NCT03823092
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A study to assess the utility of human polarization pattern perception for the detection,
      diagnosis and monitoring of eye disease
The recently described high sensitivity of the human eye to differentiate small angular
      differences in linear polarization and evidence supporting its macular origin (Misson,
      Anderson; 2017) suggests that human polarization sensitivity might be a useful diagnostic
      tool for macular disease. This augments a previous study in which we demonstrated the ability
      of the human visual system to detect isochromatic isoluminant polarization modulated pattern
      stimuli (Misson et al 2015).

      This is an exploratory 'proof-of-concept' study to determine the clinical value of
      polarization pattern perception, PPP, in health and disease. We further propose that PPP
      might be valuable for the diagnosis, monitoring and early detection of macular disease. The
      latter includes common blinding conditions such as age related macular degeneration and
      diabetic retinopathy. It is also intended to investigate the effect of cataracts and cataract
      surgery on PPP: cataract surgery modifies the optics of the eye so might also modify PPP.

      PPP is measured using a modification of the methodology described in (Misson et al 2015) and
      (Misson, Anderson; 2017) whereby polarization modulated patterns are presented on a modified
      LCD display. The observer's task is to report if they see an image and to describe the image.
      Images comprise simple patterns or traditional optotypes. A standard set of images are
      presented in pseudorandom order and the response recorded. A total score, the polarization
      pattern perception score PPP is then determined from the number of images seen/identified. A
      more refined metric, the polarization visual acuity pVA, will be derived from the response to
      the optotype stimuli. These data are then compared to conventional tests of visual structure
      and function including logMAR visual acuity, ocular examination and OCT scan data.

      The study in anticipated to comprise:

      Phase 1. Normative Evaluation: observational prospective cross-sectional.. A preliminary
      normative study will be undertaken on staff members. The aim is to quantify normative values
      in preparation for the clinical studies.

      Hypotheses to be tested:

        1. that healthy subjects can perceive polarization stimuli

        2. that there is a threshold of polarization image resolution (pVA) analogous to visual
           acuity. Normative PPP and pVA data will be collected.

      Phase 2 Patient Group: observational Prospective cross-sectional / case-control.

      Phase 2 subjects will comprise normals and patients with cataracts/pseudophakia and/or AMD,
      other macular pathology, diabetic retinopathy..

      The aim of this phase is to determine the effect, if any, of particular eye conditions on
      pVA/PPP alone and in comparison with other test parameters.

      Hypotheses to be tested:

        1. that eye conditions affect pVA/PPP

        2. that specific eye conditions have a selective effect on pVA/PPP

        3. that pseudophakia affects pVA/PPP

      Phase 3: Cataract pre-op v post op pVA/PPP: prospective interventional case-control.

      Timescale:concurrent with Phase 2 A subset of the phase 2 cataract patients will undergo
      cataract surgery according to clinical need. These patients are routinely reviewed 4 - 8
      weeks post-op when the opportunity will arise to repeat pVA/PPP measurement. The fellow eye
      will serve as a control / provide data for repeatability assessment.

      The aims of this phase are

        1. to determine the repeatability of pVA/PPP testing in a heterogeneous patient group

        2. to determine the effect of cataract surgery on the pre-operative pVA/PPP results

        3. to determine if pVA/PPP is a useful determinant of post-operative visual outcome.

      Hypotheses:

        1. that pVA/PPP testing is repeatable

        2. that there is a difference in pVA/PPP pre and post cataract surgery
observational model: Case-Control
time perspective: Cross-Sectional
measure: polarization sensitivity
time frame: 18 month
description: determine and compare polarization sensitivity between groups
arm group label: Normal
description: phakic participants with no evidence of eye disorders
arm group label: Cataract
description: participants with cataract
arm group label: AMD
description: participants with age related macular degeneration
arm group label: Pseudophakic
description: particpiants who have had cataract surgery with intraocular lens implant
arm group label: other macula
description: participants with macular ddisorders other than AMD
arm group label: DR
description: participants with diabetic retinopathy
intervention type: Diagnostic Test
intervention name: polarization sensitivity
description: test of polarization vision as described in Study Description
arm group label: AMD
arm group label: Cataract
arm group label: DR
arm group label: Normal
arm group label: Pseudophakic
arm group label: other macula
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gary P Misson, PhD FRCOphth
phone: +44 01926495321
email: gary.misson@swft.nhs.uk
last name: Jo Williams
phone: +44 01926495321
email: jo.williams@swft.nhs.uk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United Kingdom
citation: Misson GP, Timmerman BH, Bryanston-Cross PJ. Human perception of visual stimuli modulated by direction of linear polarization. Vision Res. 2015 Oct;115(Pt A):48-57. doi: 10.1016/j.visres.2015.08.004. Epub 2015 Aug 28.
PMID: 26291073
citation: Misson GP, Anderson SJ. The spectral, spatial and contrast sensitivity of human polarization pattern perception. Sci Rep. 2017 Nov 29;7(1):16571. doi: 10.1038/s41598-017-16873-6.
PMID: 29185499
responsible party type: Principal Investigator
investigator affiliation: South Warwickshire NHS Foundation Trust
investigator full name: Gary Misson
investigator title: Consultant ophthalmologist
mesh term: Macular Degeneration
mesh term: Cataract
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Pseudophakia
sharing ipd: No