<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/NCT04433702</url>
  </required_header>
  <id_info>
    <org_study_id>CP-014</org_study_id>
    <nct_id>NCT04433702</nct_id>
  </id_info>
  <brief_title>Effect of Negative Pressure on Pattern Electroretinography Readings</brief_title>
  <official_title>A Controlled, Open-Label, Randomized Study to Evaluate the Application of Negative Pressure to the Periocular Microenvironment to Alter Pattern Electroretinography Readings by Way of Modulating Intraocular Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vance Thompson Vision</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vance Thompson Vision</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Glaucoma is a leading cause of blindness worldwide. Intraocular pressure (IOP) remains the&#xD;
      only modifiable risk factor for glaucoma. Without sufficient IOP lowering therapy, glaucoma&#xD;
      induces retinal ganglion cell death and visual field loss. Pattern electroretinography (pERG)&#xD;
      measurements directly correlate with retinal ganglion cell (RGC) signaling, providing an&#xD;
      objective, repeatable, and non-invasive assessment of RGC function. The purpose of the study&#xD;
      is to investigate the pERG changes associated with acute IOP reduction using the Mercury™&#xD;
      Multi-Pressure Dial (MPD). 10 patients will be enrolled. These subjects will have a best&#xD;
      corrected visual acuity of 20/40 or better in both eyes and an established diagnosis of one&#xD;
      of either mild/moderate OAG (open-angle glaucoma), OHT (ocular hypertension), or glaucoma&#xD;
      suspect. Both eyes will be enrolled in the study. The study eye will receive a standardized&#xD;
      10 mmHg decrease in periorbital pressure via the Mercury™ Multi-Pressure Dial (MPD), and the&#xD;
      fellow/control eye will receive no (zero) pressure application. Total google wear time will&#xD;
      be 4.5 hours. Serial pERG measurements will be taken before, immediately after, and 2 hours&#xD;
      after negative pressure application.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pattern Electroretinography (pERG) Alterations</measure>
    <time_frame>0 hours; 4.5 hours; 6.5 hours</time_frame>
    <description>Mercury™ MPD alters IOP in study eyes of subjects per controlled reduction of pressure. pERG changes induced by the Mercury™ MPD will provide insight into changes in retinal ganglion cells after wearing Mercury™ MPD with negative pressure applied anterior to the orbital rim.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Glaucoma</condition>
  <condition>Open Angle, Low Risk</condition>
  <condition>Ocular Hypertension</condition>
  <condition>Glaucoma Suspect</condition>
  <arm_group>
    <arm_group_label>Experimental Eye</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mmHg of negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that only one goggle receives negative pressure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Eye</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The opposing eye serves as the intrasubject control for each participant. No negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that the other goggle does not receive negative pressure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle</intervention_name>
    <description>The Mercury™ MPD applies negative pressure to one of the two goggles inducing an IOP reduction of 10 mmHg. This is randomized for each subject in the trial.&#xD;
The Mercury™ MPD consists of:&#xD;
Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump.&#xD;
Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device</description>
    <arm_group_label>Experimental Eye</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mercury™ Multi-Pressure Dial (MPD) Placebo Goggle</intervention_name>
    <description>The Mercury™ MPD applies no negative pressure to one of the two goggles eliciting no IOP reduction. This is randomized for each subject in the trial.&#xD;
The Mercury™ MPD consists of:&#xD;
Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump.&#xD;
Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device</description>
    <arm_group_label>Control Eye</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects capable of committing to the duration of the study and signing the informed&#xD;
             consent.&#xD;
&#xD;
          -  Subjects must be male or female and ≥ 22 years of age at the time of signing the&#xD;
             informed consent.&#xD;
&#xD;
          -  Subjects with orbital anatomy that permits a proper seal when goggles are placed over&#xD;
             eyes.&#xD;
&#xD;
          -  Subjects can tolerate ERG measurements.&#xD;
&#xD;
          -  Subjects with a documented BCVA OU 20/40 or better AND a diagnosis of OHT, glaucoma&#xD;
             suspect, or OAG in both eyes. OAG definition is inclusive of normal tension glaucoma,&#xD;
             pseudoexfoliation glaucoma, and pigment dispersion. Both eyes require same diagnosis.&#xD;
&#xD;
          -  Subjects with prior surgeries such as refractive surgeries (e.g., LASIK, PRK, SMILE),&#xD;
             cataract surgery, cataract surgery with minimally invasive glaucoma surgery (MIGS),&#xD;
             MIGS alone, trabeculectomy, or implantation of other glaucoma drainage devices can be&#xD;
             included in the study; however, no other prior ocular surgeries are permitted.&#xD;
&#xD;
          -  Subjects without lenticular opacities and/or trace (i.e. 1+) lenticular opacities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of allergy to primary study device material (i.e. silicone,&#xD;
             anti-fog solution).&#xD;
&#xD;
          -  Subjects with a history of any ocular disorder or condition in either eye that would&#xD;
             likely interfere with the interpretation of the study results or subject safety (e.g.,&#xD;
             corneal transplant).&#xD;
&#xD;
          -  Subjects with a history of any demyelinating disorder or condition that would likely&#xD;
             interfere with the interpretation of the study results or subject safety (e.g. MS).&#xD;
&#xD;
          -  Subjects with an untreated retinal detachment, retinal tears, macular degeneration, or&#xD;
             any other fundus findings that may prevent accurate ERG measurements in either eye.&#xD;
&#xD;
          -  Subjects with conjunctival chemosis in either eye.&#xD;
&#xD;
          -  Subjects with eyelid edema.&#xD;
&#xD;
          -  Subjects with a history of seizure disorder.&#xD;
&#xD;
          -  Subjects with an eye infection.&#xD;
&#xD;
          -  Subjects with moderate-severe (i.e. 2+, 3+, or 4+) lenticular opacities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Greenwood, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vance Thompson Vision</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Keeley Puls</last_name>
    <phone>6053717075</phone>
    <email>keeley.puls@vancethompsonvision.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Adam Bleeker</last_name>
    <phone>6056309023</phone>
    <email>adambkeeker@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vance Thompson Vision</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keeley Puls</last_name>
      <phone>605-371-7075</phone>
      <email>keeley.puls@vancethompsonvision.com</email>
    </contact>
    <contact_backup>
      <last_name>Kristin Dunne</last_name>
      <phone>6053613937</phone>
      <email>kristin.dunne@vancethompsonvision.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 30, 2020</last_update_submitted>
  <last_update_submitted_qc>September 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glaucoma treatment</keyword>
  <keyword>multi-pressure dial</keyword>
  <keyword>pattern electroretinography</keyword>
  <keyword>open-angle glaucoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Ocular Hypertension</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/NCT04433702
org study id: CP-014
nct id: NCT04433702
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Glaucoma is a leading cause of blindness worldwide. Intraocular pressure (IOP) remains the
      only modifiable risk factor for glaucoma. Without sufficient IOP lowering therapy, glaucoma
      induces retinal ganglion cell death and visual field loss. Pattern electroretinography (pERG)
      measurements directly correlate with retinal ganglion cell (RGC) signaling, providing an
      objective, repeatable, and non-invasive assessment of RGC function. The purpose of the study
      is to investigate the pERG changes associated with acute IOP reduction using the Mercury™
      Multi-Pressure Dial (MPD). 10 patients will be enrolled. These subjects will have a best
      corrected visual acuity of 20/40 or better in both eyes and an established diagnosis of one
      of either mild/moderate OAG (open-angle glaucoma), OHT (ocular hypertension), or glaucoma
      suspect. Both eyes will be enrolled in the study. The study eye will receive a standardized
      10 mmHg decrease in periorbital pressure via the Mercury™ Multi-Pressure Dial (MPD), and the
      fellow/control eye will receive no (zero) pressure application. Total google wear time will
      be 4.5 hours. Serial pERG measurements will be taken before, immediately after, and 2 hours
      after negative pressure application.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Pattern Electroretinography (pERG) Alterations
time frame: 0 hours; 4.5 hours; 6.5 hours
description: Mercury™ MPD alters IOP in study eyes of subjects per controlled reduction of pressure. pERG changes induced by the Mercury™ MPD will provide insight into changes in retinal ganglion cells after wearing Mercury™ MPD with negative pressure applied anterior to the orbital rim.
arm group label: Experimental Eye
arm group type: Experimental
description: 10 mmHg of negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that only one goggle receives negative pressure.
arm group label: Control Eye
arm group type: Placebo Comparator
description: The opposing eye serves as the intrasubject control for each participant. No negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that the other goggle does not receive negative pressure.
intervention type: Device
intervention name: Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle
description: The Mercury™ MPD applies negative pressure to one of the two goggles inducing an IOP reduction of 10 mmHg. This is randomized for each subject in the trial.
The Mercury™ MPD consists of:
Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump.
Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device
arm group label: Experimental Eye
intervention type: Device
intervention name: Mercury™ Multi-Pressure Dial (MPD) Placebo Goggle
description: The Mercury™ MPD applies no negative pressure to one of the two goggles eliciting no IOP reduction. This is randomized for each subject in the trial.
The Mercury™ MPD consists of:
Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump.
Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device
arm group label: Control Eye
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Greenwood, MD
role: Principal Investigator
affiliation: Vance Thompson Vision
last name: Keeley Puls
phone: 6053717075
email: keeley.puls@vancethompsonvision.com
last name: Adam Bleeker
phone: 6056309023
email: adambkeeker@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Ocular Hypertension
sharing ipd: No