<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200106046032N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-17</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of polyurethane coating on corneal scratch prevention, effect of inactive lid movement on corneal scratch prevention</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the Effect of Polyurethane cover and eyelid massage on the Prevention of Keratopathy in Intensive Care Unit Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44847</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The research sample was selected based on the inclusion criteria and then randomly assigned to two groups of polyurethane coating and passive eyelid motion using random number table. Six possible modes (BBAA, AABB, ABAB, BABA, ABBA, BAAB) are listed and randomly the number of blocks required is specified and the clients are ranked accordingly.They were divided into two groups: polyurethane coating (A) and inactive lid movement (B). In each group, right eye was considered as intervention and left eye as control, Blinding description: Patients have decreased consciousness.
The outcome assessor (eye specialist) is not aware of the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>exposure keratopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group : Using polyurethane coating Askinaderm: In this study, polyurethane coating is used to create a moist chamber on the eye that restricts tear evaporation. Its dimensions range from eyebrows to cheek bumps and from the nasal bridge to one centimeter beyond the outer corner of the eye in such a way that it turns the eye rim into a closed chamber. This cover is replaced daily. Intervention 2: Intervention group:  Massage the eyelids:  Passive movement of the eyelid, massage the eyelid, or moving the eyelid gently from the root to its periphery, or the gentle pressure of the eyelids up or down, and the lateral movement from the inner corner of the eye to the outer corner.  Passive movement of  the patient's eyelids is performed by the nurse three times a day for 5 minutes. Intervention 3: Control group: Routine care: Rinse with normal saline and close with regular glue.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I tend to publish my research through a credible journal.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>FAHIMEH MASOUDI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>MANSOORIEH 9</address>
        <city>TORBAT E HEYDARIEH</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9518954746</zip>
        <telephone>+98 51 5231 7001</telephone>
        <email>farimehrmasoudi@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Masoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mansoorieh 9 Ave</address>
        <city>Torbat e heydarieh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9518954746</zip>
        <telephone>+98 51 5231 7001</telephone>
        <email>farimehrmasoudi@gmail.com</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being in the intensive care unit
Conscientiousness score less than 8 according to Glasgow criteria
No history of liver, diabetes, thyroid and ocular diseases
Age 15-15 years
Absence of eye trauma
Negative Schirmer and Fluorescein test at admission</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1.Eye trauma while studying
Relapse reflex of blinking patient
Patient discharge before intervention
Unwillingness of the patient's family to continue the study
The current clinical conditions that limit the intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group : Using polyurethane coating Askinaderm: In this study, polyurethane coating is used to create a moist chamber on the eye that restricts tear evaporation. Its dimensions range from eyebrows to cheek bumps and from the nasal bridge to one centimeter beyond the outer corner of the eye in such a way that it turns the eye rim into a closed chamber. This cover is replaced daily.</i_keyword>
      <i_keyword>Intervention group:  Massage the eyelids:  Passive movement of the eyelid, massage the eyelid, or moving the eyelid gently from the root to its periphery, or the gentle pressure of the eyelids up or down, and the lateral movement from the inner corner of the eye to the outer corner.  Passive movement of  the patient's eyelids is performed by the nurse three times a day for 5 minutes.</i_keyword>
      <i_keyword>Control group: Routine care: Rinse with normal saline and close with regular glue</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blink Disorder. Timepoint: daily. Method of measurement: Observation and examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Scratches and corneal ulcers. Timepoint: daily. Method of measurement: Fluorescein testing and use of cobalt blue light.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-21</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی گناباد</contact_name>
        <contact_address>mansoorieh 9 AVE تربت حیدریه Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
