<?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>IRCT20180107038251N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-14</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of vitamin A ointment and Liposic gel for prevention of corneal abrasion</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of vitamin A ointment and Liposic gel for prevention of corneal abrasion during general anesthesia in nonocular surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51532</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patient's two eyes are divided into two groups of intervention 1 and intervention 2 using simple random sampling method.  25 envelopes containing the letters A (right eye of vitamin A ointment and left eye of Liposic gel) and envelopes containing the letters B (right eye of Liposic gel and left eye of vitamin A ointment) are prepared. With this method, the right eye of half of patients is placed in the group of vitamin A ointment and the right eye of half of the patients is placed in the group of Liposic gel and vice versa, Blinding description: In this study,  patients and examiners are not aware of the allocation of groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Corneal abrasion.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:  As soon as anesthesia and blinking reflex disappears, in the first group, eye care is given with vitamin A so that the researcher first washes his hands and wears clean gloves, then his thumb near the lower eyelid. Apply a gentle pressure to the cheekbones and lower the eyelid to fully expose the conjunctival sac. Then apply vitamin A ointment to the patient's eye without contact with the eyelid or eyelashes and place in the bag. The conjunctiva is placed 1 cm long so that it covers the surface of the eye and then closes the patient's eye with the hand. Intervention 2: Intervention group 2:  As soon as anesthesia and blinking reflex disappears, in the second group, eye care is given with Liposic gel so that the researcher first washes his hands and wears clean gloves, then his thumb near the lower eyelid. Apply a gentle pressure to the cheekbones and lower the eyelid to fully expose the conjunctival sac. Then apply  Liposic gel to the patient's eye without contact with the eyelid or eyelashes and place in the bag. The conjunctiva is placed 1 cm long so that it covers the surface of the eye and then closes the patient's eye with the hand.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nazanin Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Paramedicine, Arak University of Medical Sciences, Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</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>Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3417 3507</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 older than 18 years and less than 75 years
Patients undergoing non-ocular surgery with general anesthesia
No obvious damage to face and eyes
Lack of recent hospitalization in intensive care unit
No eye damage before surgery according to the patient
No eye diseases (keratitis, keratopathy, glaucoma and other eye diseases)
American Society Of Anesthesiologist Physical status I and II
Patients  with endotracheal intubation
Duration of surgery between 60-300 minutes
Supine position during surgery
No allergy to fluorescein
No pregnancy
Negative preoperative fluorescein staining
No severe systemic diseases
Do not use drugs that affect the production of tears in a recent month</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Head and neck surgery
Death during surgery
Lack of patient cooperation and inability to answer questions related to ocular symptoms after surgery
Need for invasive interventions and hospitalization in intensive care units
End of surgery before 60 minutes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S05.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury of conjunctiva and corneal abrasion without foreign body</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:  As soon as anesthesia and blinking reflex disappears, in the first group, eye care is given with vitamin A so that the researcher first washes his hands and wears clean gloves, then his thumb near the lower eyelid. Apply a gentle pressure to the cheekbones and lower the eyelid to fully expose the conjunctival sac. Then apply vitamin A ointment to the patient's eye without contact with the eyelid or eyelashes and place in the bag. The conjunctiva is placed 1 cm long so that it covers the surface of the eye and then closes the patient's eye with the hand.</i_keyword>
      <i_keyword>Intervention group 2:  As soon as anesthesia and blinking reflex disappears, in the second group, eye care is given with Liposic gel so that the researcher first washes his hands and wears clean gloves, then his thumb near the lower eyelid. Apply a gentle pressure to the cheekbones and lower the eyelid to fully expose the conjunctival sac. Then apply  Liposic gel to the patient's eye without contact with the eyelid or eyelashes and place in the bag. The conjunctiva is placed 1 cm long so that it covers the surface of the eye and then closes the patient's eye with the hand</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Corneal abrasion. Timepoint: Immediately after anesthesia, when leaving the recovery room, 24 hours after surgery. Method of measurement: Fluorescein paper and a flashlight with a cobalt blue light filter are used to assess corneal abrasion.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ophthalmic discomfort. Timepoint: 24 hours after surgery. Method of measurement: Questionnaire.</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>2020-10-03</approval_date>
        <contact_name>Arak University of Medical Sciences</contact_name>
        <contact_address>Arak University of Medical Sciences, Railroad Street, Alamol Huda Street Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
