<?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>IRCT2017040733278N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-25</date_registration>
      <primary_sponsor>Department of Technology and Research of Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Effect of eye ointmet lubratex in the prevetion ocular surface disorders (OSD)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of ocular lubratex and ocular vitamin A ointment in the prevention of ocular surface disorders (OSD) in Intensive Care Unit, A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>71</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25714</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ocular Surface Disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After a standard eye care (eye wash and skin around it with normal saline) one of the eyes of patients is randomly selected. Then about two inches Lubratex Ointment every six hours, 5 days, is placed in lower eye fornix by the charge nurse and eyelids will be closed by hand.Patients on the first and fifth days are examined by using Schirmer's and fluorescin tests for corneal ulcer. Intervention 2: Control group: After a standard eye care (eye wash and skin around it with normal saline) other patient’s eye is selected. Then about two inches vitamin A Ointment every six hours, 5 days, is placed in lower eye fornix by the charge nurse and eyelids will be closed by hand. Patients on the first and fifth days are examined by using Schirmer's and fluorescin tests for corneal ulcer.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mitra Badparva</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3655173993</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>badparva@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Tir square</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3655173993</zip>
        <telephone>+98 23 3239 3811</telephone>
        <email>ebrahimi@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences. Shahroud, Iran.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age over 18 years; the healthy cornea in the initial examination; admitted to the intensive care unit for at least for 5 days; consciousness score according to the Glasgow Coma Scale less than 10; lack of trauma to the face or eyes; no history of eye problems. Exclusion criteria: having chemosis; differences of scores in the preliminary examination of the eyelid position; Bell's palsy or unilateral hemiplegia; allergy to Lubratex; closed suction method; if the patient is able to blink; corneal disorder at any stage of the testing.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H19-H22</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Disorders of sclera, cornea, iris and ciliary body</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After a standard eye care (eye wash and skin around it with normal saline) one of the eyes of patients is randomly selected. Then about two inches Lubratex Ointment every six hours, 5 days, is placed in lower eye fornix by the charge nurse and eyelids will be closed by hand.Patients on the first and fifth days are examined by using Schirmer's and fluorescin tests for corneal ulcer.</i_keyword>
      <i_keyword>Control group: After a standard eye care (eye wash and skin around it with normal saline) other patient’s eye is selected. Then about two inches vitamin A Ointment every six hours, 5 days, is placed in lower eye fornix by the charge nurse and eyelids will be closed by hand. Patients on the first and fifth days are examined by using Schirmer's and fluorescin tests for corneal ulcer.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ocular Surface Disorders. Timepoint: Before intervention- 5 days after the intervention. Method of measurement: Assessment tools for ocular surface disorders in this study including the Schirmer's and fluorescin tests. Schirmer's test once before and once when the study is completed will be done. To perform this test graded Schirmer's paper is placed in choledosac at the junction of the middle third and outer third of the eyelid and the lid is closed. After five minutes, wet bar's height is measured in millimeters. Fluorescein test once at the beginning and once on the fifth day is done.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Department of Technology and Research of Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-28</approval_date>
        <contact_name>Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud- 7th Tir square Shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
