<?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>IRCT20180107038251N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-05</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>"The effect of passive blinking on incidence of exposure keratopathy "</public_title>
      <acronym></acronym>
      <scientific_title>The effect of passive blinking exercises on exposure keratopathy in patients hospitalized in intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>51</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28767</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: block randomization,  In this method, 51patients placed the right eye in a group A and B blocking method, and the opposite eye received Inverse treatment in the right eye, Blinding description: In this study,  examiners are not aware of the allocation of groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Exposure keratopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 1.	Wash hands before eye care.2.	2. Check daily eyes with fluorescein paper and cobalt filter flashlights.3.	If eyes are closed, two tear drops will be used every four hours.4.	If there is Lagophtalmus, two tear drops every four hours and the use of ophthalmic ointment and  Close eyes with glue5.	5. Cover the eye by pad when suction6.	If there is clear damage (such as white or yellow points on the cornea or redness, swelling and conjunctivitis), be advised to the physician.In addition to care, passive blinking by the nurse will be carried out with 18 to 20 times for 30 seconds and every 30 minutes. Intervention 2: Control group: 1.	Wash hands before eye care.2.	2. Check daily eyes with fluorescein paper and cobalt filter flashlights.3.	If eyes are closed, two tear drops will be used every four hours.4.	If there is Lagophtalmus, two tear drops every four hours and the use of ophthalmic ointment and  Close eyes with glue5.	5. Cover the eye by pad when suction6.	If there is clear damage (such as white or yellow points on the cornea or redness, swelling and conjunctivitis), be advised to the physician.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The total potential data can be shared after unidentifiable people

When:
2018

To whom:
Researchers working in academia and academia

Conditions:
I have no conditions

Where to obtain:
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street
Arak,
Markazi Province,
Iran

How to obtain:
Visit to Arak Medical University, Faculty of Paramedicine,Anesthesiology Department, Ms. Amini

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nazanin Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street,Arak,Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234</zip>
        <telephone>+98 86 3417 3507</telephone>
        <email>nazaninamini69@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Korosh Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street,Arak,Iran</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234</zip>
        <telephone>+98 86 3417 3524</telephone>
        <email>k.rezaei@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients over 18 years of age;                                               Unconscious patients with GCS score less than 10 without blinking reaction;                                                                               No obvious damage to the face and eyes;                                         No  dry eyes before admission, According to companions;           No history of eye surgery according to companions;                     Do not use eye drops before admission ,                                Having no keratopathy at the start of the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>discharge or transport from ICU;                                                     death;                                                                                             Return of corneal refraction and increased consciousness (GCS score 10 and above);                                                                    Creating scratches and damage from appliances or other medical errors;                                                                                 Length of stay less than 7 days;</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H15-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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 1.	Wash hands before eye care.2.	2. Check daily eyes with fluorescein paper and cobalt filter flashlights.3.	If eyes are closed, two tear drops will be used every four hours.4.	If there is Lagophtalmus, two tear drops every four hours and the use of ophthalmic ointment and  Close eyes with glue5.	5. Cover the eye by pad when suction6.	If there is clear damage (such as white or yellow points on the cornea or redness, swelling and conjunctivitis), be advised to the physician.In addition to care, passive blinking by the nurse will be carried out with 18 to 20 times for 30 seconds and every 30 minutes.</i_keyword>
      <i_keyword>Control group: 1.	Wash hands before eye care.2.	2. Check daily eyes with fluorescein paper and cobalt filter flashlights.3.	If eyes are closed, two tear drops will be used every four hours.4.	If there is Lagophtalmus, two tear drops every four hours and the use of ophthalmic ointment and  Close eyes with glue5.	5. Cover the eye by pad when suction6.	If there is clear damage (such as white or yellow points on the cornea or redness, swelling and conjunctivitis), be advised to the physician.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Exposure keratopathy severity. Timepoint: Before the study, every morning to 1 week. Method of measurement: Examination with fluorescein paper, and flashlight with cobalt blue light filter.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-10</approval_date>
        <contact_name>•Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street,Arak,Iran Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
