<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/NCT03275441</url>
  </required_header>
  <id_info>
    <org_study_id>GN17OP146</org_study_id>
    <nct_id>NCT03275441</nct_id>
  </id_info>
  <brief_title>Electroretinography: Investigation of a Protocol Change</brief_title>
  <acronym>SHERG</acronym>
  <official_title>Investigation of a Protocol Change (Shorter Dark-adaptation) on the Electroretinogram (ERG) in an Adult Patient Population (SHERG)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NHS Greater Glasgow and Clyde</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>
      The study evaluates whether an eye test called an electroretinogram (ERG) can be shortened&#xD;
      and still produce the same diagnostic results. The results of this study may allow test times&#xD;
      to be reduced which will have benefits such as improved patient compliance during shorter&#xD;
      testing and increased clinic efficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A full-field electroretinogram (ERG) is a standardised eye test undertaken in specialist&#xD;
      hospital clinics. ERGs are useful for diagnosing and monitoring retinal diseases. The retina&#xD;
      is stimulated by showing patients flashes of light and the resulting electrical response from&#xD;
      the eye is recorded using delicate electrodes that touch the surface of the eye. For the&#xD;
      first section of the test, patient's eyes are allowed to adjust to the dark to ensure the&#xD;
      parts of the retina responsible for seeing in dimly-lit conditions are being tested.&#xD;
&#xD;
      The international ERG Standard says patients must sit in the dark for 20 minutes. The&#xD;
      investigators have evidence to suggest the test may be equally useful after only 10 minutes&#xD;
      in the dark. The investigators plan to compare ERGs recorded from patients who have spent&#xD;
      only 10 minutes in the dark with ERGs recorded from the same patients after the full 20&#xD;
      minutes in the dark. If the difference is suitably small, as found in a preliminary study of&#xD;
      healthy individuals, it could be justifiable to shorten the routine patient protocol.&#xD;
&#xD;
      Subjects for this study will be recruited from the adult population routinely attending for&#xD;
      an outpatient ERG test. During their routine ERG test, 10 minutes into the 20 minute wait in&#xD;
      the dark, the investigators propose recording an additional, identical set of ERG tests. This&#xD;
      will not add extra time to the clinical test.&#xD;
&#xD;
      Participants will not need any follow-up for the research study. The study requires 262&#xD;
      patients to test the hypothesis, and the investigators estimate this will take about 5-6&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</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>Rate of classification for ERG following 10 minute dark adaptation</measure>
    <time_frame>(During first &amp; only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation</time_frame>
    <description>The rate of classification (normal vs abnormal) for testing conducted after 10 minutes of dark adaptation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of classification (normal vs abnormal) for ERG following 20 minute dark adaptation</measure>
    <time_frame>(During first &amp; only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation</time_frame>
    <description>The rate of classification (normal vs abnormal) for testing conducted after 20 minutes of dark adaptation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response amplitude after 10 minutes</measure>
    <time_frame>(During first &amp; only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation</time_frame>
    <description>Measurement of the amplitude of responses following 10 minutes of dark adaptation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response amplitude after 20 minutes</measure>
    <time_frame>(During first &amp; only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation</time_frame>
    <description>Measurement of the amplitude of responses following 20 minutes of dark adaptation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response timing</measure>
    <time_frame>(During first &amp; only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation</time_frame>
    <description>Measurement of the amplitude of responses following 10 minutes of dark adaptation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response timing</measure>
    <time_frame>(During first &amp; only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation</time_frame>
    <description>Measurement of the amplitude of responses following 20 minutes of dark adaptation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response variability</measure>
    <time_frame>(During first &amp; only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation</time_frame>
    <description>Measurement of the variability of responses following 10 minutes of dark</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response variability</measure>
    <time_frame>(During first &amp; only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation</time_frame>
    <description>Measurement of the variability of responses following 20 minutes of dark</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">262</enrollment>
  <condition>Dark-adapted ERG</condition>
  <arm_group>
    <arm_group_label>Adult patients</arm_group_label>
    <description>Adult patients attending hospital for clinical visual electrophysiology.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Electroretinography</intervention_name>
    <description>An additional electroretinogram performed after 10 minutes of dark adaptation.</description>
    <arm_group_label>Adult patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patient population attending hospital for routine clinical electroretinography.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred to the adult visual electrophysiology service regardless of clinical&#xD;
             condition, and who require dark-adapted electroretinography as part of their&#xD;
             appointment&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  All ethnicities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years old&#xD;
&#xD;
          -  Patients who might have difficulties understanding the participant information&#xD;
             provided (for example, those patients requiring a translator, or who have learning&#xD;
             difficulties)&#xD;
&#xD;
          -  Patients with photosensitive epilepsy&#xD;
&#xD;
          -  Patients appointed for clinical testing urgently, or via telephone, who will not have&#xD;
             had an opportunity to receive and review the participant information sheet ahead of&#xD;
             the clinical appointment.&#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>Ruth Hamilton, PhD</last_name>
    <role>Study Director</role>
    <affiliation>NHS Greater Glasgow &amp; Clyde</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kirsten Graham, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS Greater Glasgow &amp; Clyde</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Richard Hagan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS Royal Liverpool University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ruth Hamilton, PhD</last_name>
    <phone>01414524217</phone>
    <email>ruth.hamilton@glasgow.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kirsten Graham, MSc</last_name>
    <phone>01412112758</phone>
    <email>kirsten.graham@nhs.net</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>March 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>electroretinogram</keyword>
  <keyword>ERG</keyword>
  <keyword>dark-adaptation</keyword>
  <keyword>ophthalmology</keyword>
  <keyword>electrophysiology</keyword>
  <keyword>ISCEV</keyword>
  <keyword>electroretinography</keyword>
  <keyword>scotopic</keyword>
  <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/NCT03275441
org study id: GN17OP146
nct id: NCT03275441
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluates whether an eye test called an electroretinogram (ERG) can be shortened
      and still produce the same diagnostic results. The results of this study may allow test times
      to be reduced which will have benefits such as improved patient compliance during shorter
      testing and increased clinic efficiency.
A full-field electroretinogram (ERG) is a standardised eye test undertaken in specialist
      hospital clinics. ERGs are useful for diagnosing and monitoring retinal diseases. The retina
      is stimulated by showing patients flashes of light and the resulting electrical response from
      the eye is recorded using delicate electrodes that touch the surface of the eye. For the
      first section of the test, patient's eyes are allowed to adjust to the dark to ensure the
      parts of the retina responsible for seeing in dimly-lit conditions are being tested.

      The international ERG Standard says patients must sit in the dark for 20 minutes. The
      investigators have evidence to suggest the test may be equally useful after only 10 minutes
      in the dark. The investigators plan to compare ERGs recorded from patients who have spent
      only 10 minutes in the dark with ERGs recorded from the same patients after the full 20
      minutes in the dark. If the difference is suitably small, as found in a preliminary study of
      healthy individuals, it could be justifiable to shorten the routine patient protocol.

      Subjects for this study will be recruited from the adult population routinely attending for
      an outpatient ERG test. During their routine ERG test, 10 minutes into the 20 minute wait in
      the dark, the investigators propose recording an additional, identical set of ERG tests. This
      will not add extra time to the clinical test.

      Participants will not need any follow-up for the research study. The study requires 262
      patients to test the hypothesis, and the investigators estimate this will take about 5-6
      months.
observational model: Cohort
time perspective: Prospective
measure: Rate of classification for ERG following 10 minute dark adaptation
time frame: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
description: The rate of classification (normal vs abnormal) for testing conducted after 10 minutes of dark adaptation.
measure: Rate of classification (normal vs abnormal) for ERG following 20 minute dark adaptation
time frame: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
description: The rate of classification (normal vs abnormal) for testing conducted after 20 minutes of dark adaptation.
measure: Response amplitude after 10 minutes
time frame: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
description: Measurement of the amplitude of responses following 10 minutes of dark adaptation.
measure: Response amplitude after 20 minutes
time frame: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
description: Measurement of the amplitude of responses following 20 minutes of dark adaptation.
measure: Response timing
time frame: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
description: Measurement of the amplitude of responses following 10 minutes of dark adaptation.
measure: Response timing
time frame: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
description: Measurement of the amplitude of responses following 20 minutes of dark adaptation.
measure: Response variability
time frame: (During first & only study visit) Dark-adapted ERG test following 10 minutes of dark adaptation
description: Measurement of the variability of responses following 10 minutes of dark
measure: Response variability
time frame: (During first & only study visit) Dark-adapted ERG test following 20 minutes of dark adaptation
description: Measurement of the variability of responses following 20 minutes of dark
arm group label: Adult patients
description: Adult patients attending hospital for clinical visual electrophysiology.
intervention type: Diagnostic Test
intervention name: Electroretinography
description: An additional electroretinogram performed after 10 minutes of dark adaptation.
arm group label: Adult patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ruth Hamilton, PhD
role: Study Director
affiliation: NHS Greater Glasgow & Clyde
last name: Kirsten Graham, MSc
role: Principal Investigator
affiliation: NHS Greater Glasgow & Clyde
last name: Richard Hagan, PhD
role: Principal Investigator
affiliation: NHS Royal Liverpool University Hospital
last name: Ruth Hamilton, PhD
phone: 01414524217
email: ruth.hamilton@glasgow.ac.uk
last name: Kirsten Graham, MSc
phone: 01412112758
email: kirsten.graham@nhs.net
responsible party type: Sponsor
sharing ipd: No