<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/NCT03762889</url>
  </required_header>
  <id_info>
    <org_study_id>20180875</org_study_id>
    <nct_id>NCT03762889</nct_id>
  </id_info>
  <brief_title>Peri-operative Application of Eyeprotx General Anesthesia Goggles As Prevention Against Corneal Injury Post Intubation.</brief_title>
  <official_title>Peri-operative Application of EYEPROTX General Anesthesia Protective Goggles as an Effective Modality to Reduce the Incidence of Corneal Injury Post-Intubation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled trial that seeks to examine the effectiveness of Eyeprotx™&#xD;
      protective goggles in comparison to traditional methods against ocular injury that can occur&#xD;
      perioperatively under general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ocular injury is but a devastating condition that can occur perioperatively under general&#xD;
      anesthesia. Corneal abrasion is the most common ocular injury during general anesthesia,&#xD;
      surpassing case incidence of damage caused by patient movement in ophthalmologic surgery.&#xD;
      Causes of ocular injury include corneal drying due to the suppression of tear ducts from&#xD;
      anesthetic agents, direct physical trauma, or agitation from the volatile anesthetic used.&#xD;
      Ocular injury may also occur due to bacterial infection with MRSA, preventative methods, or&#xD;
      rubbing of the eyes postoperatively due to agitation. Agitation may be caused by corneal&#xD;
      drying or by shift or disruption in rapid eye movement sleep cycle from light penetration&#xD;
      through the eyelids. Attempts at prevention of corneal abrasion have been used, including&#xD;
      taping the eyelids shut, manual eye closure, paraffin-based ointment application into the&#xD;
      conjunctival sac, and the use of hydrophilic contact lenses, although only a few studies have&#xD;
      validated the comparison of these methods' effectiveness.&#xD;
&#xD;
      Eyeprotx™ Protective Goggles have been designed specifically for use in the operating room or&#xD;
      in any scenario where general anesthesia must be used, such as intubation in an emergency.&#xD;
      Current ocular protective measures such as tapes during anesthesia have been associated with&#xD;
      injury and infection. With this study, we hope to find a safer preventative technique against&#xD;
      ocular injury during the perioperative period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Trial no longer occurring.&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>In this cohort study, 100 preoperative patients from Jackson Memorial Hospital would be randomly assigned based on age, gender, and type of anesthesia to three samples: anesthesia with Eyeprotx™ Goggles, anesthesia with eyelid tape, and anesthesia with ointment application. Analysis of samples will be based on length of procedure, length of preventative measure application, position during operation(supine or prone), and postoperative events. Patient discomfort or pain, eye dryness intensity would be rated on numerical rating scale. Qualitative analysis will include additional comments from patients and the anesthesiologist.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Baseline Ocular Condition post-operatively</measure>
    <time_frame>The patient's initial rating will be recorded approximately ten minutes before surgery at the point of anesthesia evaluation and will be reassessed up to 24 hours post-operatively.</time_frame>
    <description>The following will be measured upon evaluation, using a numerical scale of 1 to 8, with 1 being complete absence of condition and 8 being the most severe presentation of the condition:&#xD;
1. eye discomfort, 2, pain, and 3. dryness intensity, each on a numerical rating-scale of 1 to 8, The measures will be compared among the goggle, ointment, and tape groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of Ocular Complications post-operation</measure>
    <time_frame>Evaluation of these complications will be done from the point the patient has returned to the recovery room to up to one week post-surgery or until discharge, whichever comes first.</time_frame>
    <description>Incidence of corneal abrasion, conjunctivitis, MRSA infection, and direct ocular trauma will be assessed by the anesthesiologist or nurse anesthetist and will be recorded upon diagnosis of condition for all groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Awareness during Anesthesia</measure>
    <time_frame>This measure will be evaluated up to 48 hours post-surgical operation.</time_frame>
    <description>Patient awareness of being under anesthesia will be recorded qualitatively, with accounts of anxiety and/or fear being noted, if applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Nightmare during Use</measure>
    <time_frame>This measure will be evaluated up to 48 hours post-surgical operation.</time_frame>
    <description>Patient's report of experiencing nightmares during the surgery will be recorded qualitatively.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Usability Scale Per Operator</measure>
    <time_frame>This measure will be evaluated up to 6 months after the post-surgical operation.</time_frame>
    <description>The anesthesiologists and nurse anesthetists working on the trial will be asked to complete a usability scale questionnaire to evaluate the effectiveness of the different variation of the goggles, such as goggles with a strap versus goggles with short sterilized adhesive tape.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Corneal Injuries</condition>
  <arm_group>
    <arm_group_label>Eyeprotx™ Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of participants will use the Eyeprotx™ General Anesthesia Protective Goggles when intubated perioperatively under general anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eyelid Tape Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group of participants will be receiving the eyelid tape as the preventative measure when intubated perioperatively under general anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eye Ointment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group of participants will be receiving the ointment application when intubated perioperatively under general anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Eyeprotx™ General Anesthesia Protective Goggles</intervention_name>
    <description>Eyeprotx™ Protective Goggles have been designed specifically for use in the operating room or in any scenario where general anesthesia must be used, such as intubation in an emergency. The integral function is to reduce intraocular pressure while in place, prevent operating room bright light penetration, facilitate a swift placement preventative measure with straps, form a barrier against bacterial invasion and mechanical damage. This study would seek to examine this goggles' effectiveness as a preventative measure as vs. other measures.</description>
    <arm_group_label>Eyeprotx™ Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Eyelid Tape</intervention_name>
    <description>Taping the eyelids during intubation is one of the standard techniques used perioperatively under general anesthesia. This intervention would be used for the Eyelid Tape Group.</description>
    <arm_group_label>Eyelid Tape Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Eye Ointment</intervention_name>
    <description>Another standard technique used perioperatively under general anesthesia is to apply an ointment to the eye for lubrication. This intervention would be applied to the Eye Ointment Group.</description>
    <arm_group_label>Eye Ointment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing general anesthesia&#xD;
&#xD;
          -  Patients admitted to Jackson Memorial Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to communicate, for whatever reason&#xD;
&#xD;
          -  Patients predisposed to eye conditions&#xD;
&#xD;
          -  Patients with history of increased intraocular pressure&#xD;
&#xD;
          -  Patients with a medical history of Sicca syndrome&#xD;
&#xD;
          -  Patients with claustrophobia&#xD;
&#xD;
          -  Patients with pseudoexfoliation syndromes&#xD;
&#xD;
          -  Patients with a current exopthalmic condition&#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_official>
    <last_name>Adam M Au, DO MD PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jackson Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jackson Memorial Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://journals.lww.com/anesthesia-analgesia/Abstract/1975/07000/Corneal_Injuries_During_General_Anesthesia.14.aspx</url>
    <description>&quot;Corneal Injuries During General Anesthesia&quot;, Snow et al</description>
  </link>
  <reference>
    <citation>Gild WM, Posner KL, Caplan RA, Cheney FW. Eye injuries associated with anesthesia. A closed claims analysis. Anesthesiology. 1992 Feb;76(2):204-8. doi: 10.1097/00000542-199202000-00008.</citation>
    <PMID>1736697</PMID>
  </reference>
  <reference>
    <citation>Figueiro MG, Rea MS. Preliminary evidence that light through the eyelids can suppress melatonin and phase shift dim light melatonin onset. BMC Res Notes. 2012 May 7;5:221. doi: 10.1186/1756-0500-5-221.</citation>
    <PMID>22564396</PMID>
  </reference>
  <reference>
    <citation>White E, Crosse MM. The aetiology and prevention of peri-operative corneal abrasions. Anaesthesia. 1998 Feb;53(2):157-61. doi: 10.1046/j.1365-2044.1998.00269.x.</citation>
    <PMID>9534639</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>June 4, 2019</last_update_submitted>
  <last_update_submitted_qc>June 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Leo Kleyman</investigator_full_name>
    <investigator_title>Research Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Corneal Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03762889
org study id: 20180875
nct id: NCT03762889
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This is a randomized controlled trial that seeks to examine the effectiveness of Eyeprotx™
      protective goggles in comparison to traditional methods against ocular injury that can occur
      perioperatively under general anesthesia.
Ocular injury is but a devastating condition that can occur perioperatively under general
      anesthesia. Corneal abrasion is the most common ocular injury during general anesthesia,
      surpassing case incidence of damage caused by patient movement in ophthalmologic surgery.
      Causes of ocular injury include corneal drying due to the suppression of tear ducts from
      anesthetic agents, direct physical trauma, or agitation from the volatile anesthetic used.
      Ocular injury may also occur due to bacterial infection with MRSA, preventative methods, or
      rubbing of the eyes postoperatively due to agitation. Agitation may be caused by corneal
      drying or by shift or disruption in rapid eye movement sleep cycle from light penetration
      through the eyelids. Attempts at prevention of corneal abrasion have been used, including
      taping the eyelids shut, manual eye closure, paraffin-based ointment application into the
      conjunctival sac, and the use of hydrophilic contact lenses, although only a few studies have
      validated the comparison of these methods' effectiveness.

      Eyeprotx™ Protective Goggles have been designed specifically for use in the operating room or
      in any scenario where general anesthesia must be used, such as intubation in an emergency.
      Current ocular protective measures such as tapes during anesthesia have been associated with
      injury and infection. With this study, we hope to find a safer preventative technique against
      ocular injury during the perioperative period.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: In this cohort study, 100 preoperative patients from Jackson Memorial Hospital would be randomly assigned based on age, gender, and type of anesthesia to three samples: anesthesia with Eyeprotx™ Goggles, anesthesia with eyelid tape, and anesthesia with ointment application. Analysis of samples will be based on length of procedure, length of preventative measure application, position during operation(supine or prone), and postoperative events. Patient discomfort or pain, eye dryness intensity would be rated on numerical rating scale. Qualitative analysis will include additional comments from patients and the anesthesiologist.
primary purpose: Prevention
masking: None (Open Label)
measure: Changes in Baseline Ocular Condition post-operatively
time frame: The patient's initial rating will be recorded approximately ten minutes before surgery at the point of anesthesia evaluation and will be reassessed up to 24 hours post-operatively.
description: The following will be measured upon evaluation, using a numerical scale of 1 to 8, with 1 being complete absence of condition and 8 being the most severe presentation of the condition:
1. eye discomfort, 2, pain, and 3. dryness intensity, each on a numerical rating-scale of 1 to 8, The measures will be compared among the goggle, ointment, and tape groups.
measure: Incidence of Ocular Complications post-operation
time frame: Evaluation of these complications will be done from the point the patient has returned to the recovery room to up to one week post-surgery or until discharge, whichever comes first.
description: Incidence of corneal abrasion, conjunctivitis, MRSA infection, and direct ocular trauma will be assessed by the anesthesiologist or nurse anesthetist and will be recorded upon diagnosis of condition for all groups.
measure: Patient Awareness during Anesthesia
time frame: This measure will be evaluated up to 48 hours post-surgical operation.
description: Patient awareness of being under anesthesia will be recorded qualitatively, with accounts of anxiety and/or fear being noted, if applicable.
measure: Incidence of Nightmare during Use
time frame: This measure will be evaluated up to 48 hours post-surgical operation.
description: Patient's report of experiencing nightmares during the surgery will be recorded qualitatively.
measure: Usability Scale Per Operator
time frame: This measure will be evaluated up to 6 months after the post-surgical operation.
description: The anesthesiologists and nurse anesthetists working on the trial will be asked to complete a usability scale questionnaire to evaluate the effectiveness of the different variation of the goggles, such as goggles with a strap versus goggles with short sterilized adhesive tape.
arm group label: Eyeprotx™ Group
arm group type: Experimental
description: This group of participants will use the Eyeprotx™ General Anesthesia Protective Goggles when intubated perioperatively under general anesthesia.
arm group label: Eyelid Tape Group
arm group type: Active Comparator
description: This group of participants will be receiving the eyelid tape as the preventative measure when intubated perioperatively under general anesthesia.
arm group label: Eye Ointment Group
arm group type: Active Comparator
description: This group of participants will be receiving the ointment application when intubated perioperatively under general anesthesia.
intervention type: Device
intervention name: Eyeprotx™ General Anesthesia Protective Goggles
description: Eyeprotx™ Protective Goggles have been designed specifically for use in the operating room or in any scenario where general anesthesia must be used, such as intubation in an emergency. The integral function is to reduce intraocular pressure while in place, prevent operating room bright light penetration, facilitate a swift placement preventative measure with straps, form a barrier against bacterial invasion and mechanical damage. This study would seek to examine this goggles' effectiveness as a preventative measure as vs. other measures.
arm group label: Eyeprotx™ Group
intervention type: Device
intervention name: Eyelid Tape
description: Taping the eyelids during intubation is one of the standard techniques used perioperatively under general anesthesia. This intervention would be used for the Eyelid Tape Group.
arm group label: Eyelid Tape Group
intervention type: Device
intervention name: Eye Ointment
description: Another standard technique used perioperatively under general anesthesia is to apply an ointment to the eye for lubrication. This intervention would be applied to the Eye Ointment Group.
arm group label: Eye Ointment Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Adam M Au, DO MD PHD
role: Principal Investigator
affiliation: Jackson Health System
facility: 
country: United States
url: https://journals.lww.com/anesthesia-analgesia/Abstract/1975/07000/Corneal_Injuries_During_General_Anesthesia.14.aspx
description: "Corneal Injuries During General Anesthesia", Snow et al
citation: Gild WM, Posner KL, Caplan RA, Cheney FW. Eye injuries associated with anesthesia. A closed claims analysis. Anesthesiology. 1992 Feb;76(2):204-8. doi: 10.1097/00000542-199202000-00008.
PMID: 1736697
citation: Figueiro MG, Rea MS. Preliminary evidence that light through the eyelids can suppress melatonin and phase shift dim light melatonin onset. BMC Res Notes. 2012 May 7;5:221. doi: 10.1186/1756-0500-5-221.
PMID: 22564396
citation: White E, Crosse MM. The aetiology and prevention of peri-operative corneal abrasions. Anaesthesia. 1998 Feb;53(2):157-61. doi: 10.1046/j.1365-2044.1998.00269.x.
PMID: 9534639
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Leo Kleyman
investigator title: Research Fellow
mesh term: Corneal Injuries
mesh term: Wounds and Injuries
mesh term: Anesthetics
sharing ipd: Undecided