<?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>IRCT2014072418581N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-11</date_registration>
      <primary_sponsor>Vice chancellor for research, Azad University of Medical Sciences</primary_sponsor>
      <public_title>Ocular complications following the use of  Vitamin A and  simple eye ointment  in non- ophthalmic surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of ocular complications following the use of  Vitamin A and simple eye topical ointment in non-ophthalmic surgery during general anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16810</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Using the random blocks.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Eye pain, Blurry vision, Tearing, Red eye, Photophobia, Foreign body sensation, Allergic reactions, Periorbital edema, Itchy, Sticking of the eyes together, Conjunctiva hyperemia, Scleral erythema, Corneal erosions.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: (Two standards common types of eye ointments simultaneously into one patient's eye during general anesthesia). Vitamin A ointment (Xerovit, containing 250 units per  gram of vitamin A palmitate at the base of Vaseline) without tape into one eye and simple eye ointment(Lubratex, Yellow Soft Paraffin 80 g, Wool Fat 10 g, Liquid Paraffin QS to 100 g) without tape is applied into another eye of patients (A thin layer of ointment approximately one centimeter is placed inside the lower eyelid during anesthesia). Intervention 2: Intervention group 2: (one type of common standard eye ointment into both patient's eye during general anesthesia).  Vitamin A ointment is applied into both eyes of patients and simple eye ointment into both eyes of patients (A thin layer of ointment approximately one centimeter is placed inside the lower eyelid during anesthesia).</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>Seyedehsara Bayesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Medical Sciences Branch, Islamic Azad University, Khaghani St, Shariati Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19395/1495</zip>
        <telephone>+98 912 124 2941</telephone>
        <email>sarabayesh@yahoo.com; frgholami@gmail.com</email>
        <affiliation>Islamic Azad University, Tehran Medical Sciences Branch, Tehran, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Farshid Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Medical Sciences Branch, Islamic Azad UniversityT, khaghani St, shariati Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19395/1495</zip>
        <telephone>+98 912 124 2941</telephone>
        <email>frgholami@gmail.com; iautmu@iautmu.ac.ir; sarabayesh@yahoo.com</email>
        <affiliation>Islamic Azad University, Tehran Medical Sciences Branch, Tehran, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: In this study, all patients undergoing general anesthesia for non-ophthalmic surgery are being studied.&#13;
&#13;
Exclusion criteria: Patients who have a history of ocular surgery; Patients who wear eye contact lenses; Patients who have visual acuity of less than 20/100; patients who have a history of ocular disease; Patients who are allergic to adhesive tape or eye ointment; Pregnant Women; Patients with conjunctivitis; ocular prosthesis; ocular hypoperfusion secondary to hypotension or anemia or using a beta blocker and a diuretic such as hydrochlorothiazide  due to  decrease in tear production base are excluded.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H59.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postprocedural disorder of eye and adnexa, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: (Two standards common types of eye ointments simultaneously into one patient's eye during general anesthesia). Vitamin A ointment (Xerovit, containing 250 units per  gram of vitamin A palmitate at the base of Vaseline) without tape into one eye and simple eye ointment(Lubratex, Yellow Soft Paraffin 80 g, Wool Fat 10 g, Liquid Paraffin QS to 100 g) without tape is applied into another eye of patients (A thin layer of ointment approximately one centimeter is placed inside the lower eyelid during anesthesia).</i_keyword>
      <i_keyword>Intervention group 2: (one type of common standard eye ointment into both patient's eye during general anesthesia).  Vitamin A ointment is applied into both eyes of patients and simple eye ointment into both eyes of patients (A thin layer of ointment approximately one centimeter is placed inside the lower eyelid during anesthesia).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Any type of eye complications as eye pain, Blurry vision, Tearing, Red eye, Photophobia, Foreign body sensation, Allergic reactions, Periorbital edema, Itchy, sticking of the eyes together, Conjunctiva hyperemia, Scleral erythema, Corneal erosions. Timepoint: 3to5 hours after general anesthesia, within the 24 hours after anesthesia, after discharge, more investigating in case of any complications. Method of measurement: Visual Analog Scale(VAS), Snellen Eye Chart, Schirmer's test,Scoring system for periorbital oedema, Oxford Schema.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: 3to5 hours after general anesthesia, within the 24 hours after anesthesia, after discharge, more investigating in case of any complications. Method of measurement: Visual Analog Scale(VAS), Snellen Eye Chart, Schirmer's test, Scoring system for periorbital oedema, Oxford Schema.</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>Vice chancellor for research, Azad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-11-15</approval_date>
        <contact_name>Ethics committee of Islamic Azad University of Medical Sciences Branch</contact_name>
        <contact_address>Tehran Medical Sciences Branch, Islamic Azad University, Khaghani St, Shariati Ave Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
