<?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>IRCT20140307016870N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-13</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of an the effect of eye care protocol and routine eye care on superficial eye disorders in ICU patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of an eye care protocol on the incidence of ocular surface disorders in patients admitted to intensive care unit.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43493</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Corneal surface disorders.</hc_freetext>
      <i_freetext>Intervention group (Left eye): Eye for risk factors for superficial disorders (decreased blink reflex, sedative use, mechanical ventilation with PEEP greater than 5, ventilation in chronic condition, conjunctival edema, metabolic, cardiac or renal impairment) Was reviewed and recorded daily. Complete closure of the eyelid (Grade Lagophthalmos: Grade 1: Complete eyelid closure, Grade 2: Contact conjunctiva, Grade 3: Contact cornea) were recorded every eight hours. Measures for grade 1 and 2 Lagophthalmos include: Washing hands before and after the procedure, applying lubricant in the inferior conjunctival sac for 1 hour every 4 hours, closing the eye, suctioning the chip on one side of the bed with eyes closed, and if there is an infection Or blinking from time to time. Symptoms of ocular infection (redness, runny nose, swelling of the eyelids, conjunctivitis, hyperemia, peripheral eyelid crust) were recorded every four hours. Measures include: washing hands before and after the procedure, cleaning the eyelids every 4 hours and every 2 hours in the presence of excessive eye discharge or respiratory infection (cleaning the eyelid with gas and swallowing in one direction from the inside out). Superficial dry eye (opacity or opacity of the eye) was recorded every four hours. Measures include, hand washing before and after the procedure, eye hygiene cleaning the eyelids every 2 hours (cleaning the eyelid with gas and swapping in one direction from the outside), applying lubricant in the lower conjunctival sac 1 cm Every 4 hours or so, the eyes were not closed if there was an infection or blink. Superficial ocular abnormalities (corneal opacity, epithelial deficiency, corneal insufficiency, localized white spots) were recorded daily. Measures include: Ophthalmologic consultation, Eye hygiene cleaning of the eyelids every 2 hours (cleaning the eyelid with gas and swapping in one direction from the inside out), applying lubricant in the lower conjunctival sac for 1 hour every 4 hours and closing the eye.                                                                                Control group (right eye): Eye for risk factors for superficial disorders (reduction of blink reflex, sedative use, mechanical ventilation with PEEP greater than 5, ventilation in chronic condition, conjunctival edema, metabolic, cardiac or renal impairment) Daily recorded and recorded. Complete closure of the eyelid (Grade Lagophthalmos: Grade 1: Complete eyelid closure, Grade 2: Contact conjunctiva, Grade 3: Contact cornea) were recorded every eight hours. Symptoms of ocular infection (redness, runny nose, swelling of the eyelids, conjunctivitis, hyperemia, peripheral eyelid crust) were recorded every four hours. Superficial dry eye (opacity or opacity of the eye) was recorded every four hours. Superficial ocular abnormalities (corneal opacity, epithelial deficiency, corneal insufficiency, localized white spots) were recorded daily. Routine care was performed including washing the eyes with sterile gas impregnated with normal saline every eight hours (once per shift)..</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 primary outcome data is shared

When:
Start of access period 6 months after printing results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Perform meta-analysis and systematic review

Where to obtain:
Dr khadijeh nasiriani, School of Nursing and Midwifery Yazd؛ In Front of the
Infertility Center؛ Safaieh street؛ Bu Ali Boulevard, postal code: 00983518241755, 00989133593437

How to obtain:
Send email to Azam Purghafari Lahiji by email: apourghaffarilahiji@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>azam pourghaffari lahiji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd University of Medical Sciences, School of Nursing and Midwifery Yazd</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8913893111</zip>
        <telephone>+98 35 6260001</telephone>
        <email>apourghaffarilahiji@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>azam pourghaffari lahiji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>In Front of the Infertility Center, Safaieh street, Bu Ali Boulevard</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8913893111</zip>
        <telephone>+98 35 3626 0001</telephone>
        <email>apourghaffarilahiji@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Admitted to intensive care unit
Reduce the level of consciousness to a maximum of 8
Corneal surface health at initial examination
Requires mechanical ventilation and sedation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Facial and eye trauma in a way that prevents eye care
History of Ocular Problems (Ocular Diseases, Eye Infection, Ocular Trauma, Chronic Lagophthalmos, Ocular Drugs and Allergies)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H16.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified keratitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (Left eye): Eye for risk factors for superficial disorders (decreased blink reflex, sedative use, mechanical ventilation with PEEP greater than 5, ventilation in chronic condition, conjunctival edema, metabolic, cardiac or renal impairment) Was reviewed and recorded daily. Complete closure of the eyelid (Grade Lagophthalmos: Grade 1: Complete eyelid closure, Grade 2: Contact conjunctiva, Grade 3: Contact cornea) were recorded every eight hours. Measures for grade 1 and 2 Lagophthalmos include: Washing hands before and after the procedure, applying lubricant in the inferior conjunctival sac for 1 hour every 4 hours, closing the eye, suctioning the chip on one side of the bed with eyes closed, and if there is an infection Or blinking from time to time. Symptoms of ocular infection (redness, runny nose, swelling of the eyelids, conjunctivitis, hyperemia, peripheral eyelid crust) were recorded every four hours. Measures include: washing hands before and after the procedure, cleaning the eyelids every 4 hours and every 2 hours in the presence of excessive eye discharge or respiratory infection (cleaning the eyelid with gas and swallowing in one direction from the inside out). Superficial dry eye (opacity or opacity of the eye) was recorded every four hours. Measures include, hand washing before and after the procedure, eye hygiene cleaning the eyelids every 2 hours (cleaning the eyelid with gas and swapping in one direction from the outside), applying lubricant in the lower conjunctival sac 1 cm Every 4 hours or so, the eyes were not closed if there was an infection or blink. Superficial ocular abnormalities (corneal opacity, epithelial deficiency, corneal insufficiency, localized white spots) were recorded daily. Measures include: Ophthalmologic consultation, Eye hygiene cleaning of the eyelids every 2 hours (cleaning the eyelid with gas and swapping in one direction from the inside out), applying lubricant in the lower conjunctival sac for 1 hour every 4 hours and closing the eye.                                                                                Control group (right eye): Eye for risk factors for superficial disorders (reduction of blink reflex, sedative use, mechanical ventilation with PEEP greater than 5, ventilation in chronic condition, conjunctival edema, metabolic, cardiac or renal impairment) Daily recorded and recorded. Complete closure of the eyelid (Grade Lagophthalmos: Grade 1: Complete eyelid closure, Grade 2: Contact conjunctiva, Grade 3: Contact cornea) were recorded every eight hours. Symptoms of ocular infection (redness, runny nose, swelling of the eyelids, conjunctivitis, hyperemia, peripheral eyelid crust) were recorded every four hours. Superficial dry eye (opacity or opacity of the eye) was recorded every four hours. Superficial ocular abnormalities (corneal opacity, epithelial deficiency, corneal insufficiency, localized white spots) were recorded daily. Routine care was performed including washing the eyes with sterile gas impregnated with normal saline every eight hours (once per shift).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dry eye. Timepoint: Daily. Method of measurement: With fluorescein tape, according to a grading system.</prim_outcome>
      <prim_outcome>Ocular surface disoeder. Timepoint: Daily. Method of measurement: With fluorescein tape, according to a grading system.</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>Vice chancellor for research, Yazd University of MedicalSciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-16</approval_date>
        <contact_name>Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>School of Nursing &amp; Midwifery, Buali street, Safaieh, Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
