<?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>IRCT20200204046370N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-13</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the Effectiveness of Three Methods of eye care in the prevention of keratitis  disorders In patients (ICU)</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effectiveness of Three Methods of eye care in the prevention of keratitis  disorders In patients (ICU)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45688</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Nothing, Randomization description: Simple randomization is used.Roll OF a die was used. So that the numbers 1 and 4 methods of eye ointment and anti-allergic adhesive, Numbers 2 and 5 Ophthalmic ointment and anti-allergic adhesive, Numbers 3 and 6 had anti-allergic adhesive and artificial tears. The randomization unit has also been individualized. Initially, any patient that entered the special ward ,examined by a specialist ICU physician and Inclusion and exclusion criteria were evaluated. If the patient met the inclusion criteria  The patient was assigned to one of the treatment groups byrol of a die By a researcher . Then the eye care was done by another researcher and an eye examination was performed by an ophthalmologist.In order to conceal the throwing of the dice, it was done by the secretary who did not know the type of treatment in the groups, so that when the disease was accepted and approved by a special care specialist to attend the study, the secretary who was not part of the research team Throwing a dice determined which group the patient was in and informed the researcher
It didn't happen random layers and random sequences, Blinding description: The subjects in this study were comatose patients. So they were not aware of their eye care. The person doing the eye care was a researcher .But the eye examination was done by an ophthalmologist who was not aware of the type of eye care. In this way, before the start of the eye examination, the type of care was cleared from the patient's eye. And the one who did the data analysis It only had group numbers And the type of care provided in each group was not known.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Keratitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Ointment and anti-allergenic adhesive. Ointment care :Every 6 hours by a trained nurse investigator in one of the patient's eyes about 2 cm of ointment in the inferior fornix from the inside out with the sterilization technique, so that about 1 cm of the ointment is poured out at the beginning of the ointment and Avoid contact with the patient's eye ointment and have the nurse thoroughly wash their hands as well as any ointment specific to the patient. After pouring the ointment, the patient's eyes are gently closed and checked every two hours by the nurse for the eyelid to be closed. Every 6 hours the patient's eyes are washed by the nurse with sterile water and cotton. Care with anti-allergic adhesive (1 / 25cm wide)Every 6 hours, the eyelid is closed with an anti-allergic adhesive with a width of 1.27. In such a way that one piece of adhesive is placed horizontally on the upper eyelid and the other piece is placed vertically on the patient's eyelid so that it rests on the patient's cheek and eyelid. Examines in terms of damage. If the adhesive needs to be renewed, this will be done. Every 6 hours the patient's eyes will be rinsed with sterile water and cotton and the eye care will be re-applied.Eye care was performed 3 times every 24 hours. Eye care was performed at night.Consumption of sterile plain eye ointment 3.5 g (Lubratex): (lanolin content 10%, white platelet 80% and mineral oil 10%).CompanySina Daroo Tehran.Anti-allergic adhesive with width: 1/27.Company Sins Max. Intervention 2: Intervention group: Intervention group 1: Ointment and artificial tear. Ointment care :Every 6 hours by a trained nurse investigator in one of the patient's eyes about 2 cm of ointment in the inferior fornix from the inside out with the sterilization technique, so that about 1 cm of the ointment is poured out at the beginning of the ointment and Avoid contact with the patient's eye ointment and have the nurse thoroughly wash their hands as well as any ointment specific to the patient. After pouring the ointment, the patient's eyes are gently closed and checked every two hours by the nurse for the eyelid to be closed. Every 6 hours the patient's eyes are washed by the nurse with sterile water and cotton.Another patient's eye care was performed with artificial tears. That is, every 6 hours the nurse in charge trained by the researcher washes her hands and pours artificial tears into the other eye. For further care of the patient's eyes, the nurse is rinsed with sterile water and cotton, and the procedure is repeated again..Eye care was performed 3 times every 24 hours. Eye care was performed at night.Consumption of sterile plain eye ointment 3.5 g (Lubratex): (lanolin content 10%, white platelet 80% and mineral oil 10%).CompanySina Daroo Tehran.Sina Darou Tehran Artificial Tears. Intervention 3: Intervention group:anti-allergenic adhesive and artificial tear. Care with anti-allergic adhesive (1 / 25cm wide)Every 6 hours, the eyelid is closed with an anti-allergic adhesive with a width of 1.27. In such a way that one piece of adhesive is placed horizontally on the upper eyelid and the other piece is placed vertically on the patient's eyelid so that it rests on the patient's cheek and eyelid. Examines in terms of damage. If the adhesive needs to be renewed, this will be done. Every 6 hours the patient's eyes will be rinsed with sterile water and cotton and the eye care will be re-applie..Another patient's eye care was performed with artificial tears. That is, every 6 hours the nurse in charge trained by the researcher washes her hands and pours artificial tears into the other eye. For further care of the patient's eyes, the nurse is rinsed with sterile water and cotton, and the procedure is repeated again..Eye care was performed 3 times every 24 hours. Eye care was performed at night.Consumption of.Anti-allergic adhesive with width: 1/27.Company Sins Max and .Sina Darou Tehran Artificial Tears.</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:
All data can be published

When:
6 months after printing the results

To whom:
Specialists affiliated with medical universities

Conditions:
Nurses working in the intensive care unit

Where to obtain:
Efazljoo@gmail.com

How to obtain:
Necessary information on the cause of the need for data information
Documentation needed for data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Fazljoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, Fifth Alley, Shahd Zinly Alley, Fajr Dahi Boulevard</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8914946819</zip>
        <telephone>+98 35 3624 6804</telephone>
        <email>ٍEfazljoo@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ٍElham Fazljoo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, Fifth Alley, Shahd Zinly Alley, Fajr Dahi Boulevard</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8914946819</zip>
        <telephone>+98 35 3624 6804</telephone>
        <email>Efazljoo@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with decreased consciousness below 8.
Connect the ventilator
Impaired blink reflex
Age over 18 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with eye damage at admission
Patients who have had a history of diabetes and hypertension
Patients whose fluorescein test is positive at admission
Patients with trauma or injury.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H16.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Corneal ulcer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Ointment and anti-allergenic adhesive. Ointment care :Every 6 hours by a trained nurse investigator in one of the patient's eyes about 2 cm of ointment in the inferior fornix from the inside out with the sterilization technique, so that about 1 cm of the ointment is poured out at the beginning of the ointment and Avoid contact with the patient's eye ointment and have the nurse thoroughly wash their hands as well as any ointment specific to the patient. After pouring the ointment, the patient's eyes are gently closed and checked every two hours by the nurse for the eyelid to be closed. Every 6 hours the patient's eyes are washed by the nurse with sterile water and cotton. Care with anti-allergic adhesive (1 / 25cm wide)Every 6 hours, the eyelid is closed with an anti-allergic adhesive with a width of 1.27. In such a way that one piece of adhesive is placed horizontally on the upper eyelid and the other piece is placed vertically on the patient's eyelid so that it rests on the patient's cheek and eyelid. Examines in terms of damage. If the adhesive needs to be renewed, this will be done. Every 6 hours the patient's eyes will be rinsed with sterile water and cotton and the eye care will be re-applied.Eye care was performed 3 times every 24 hours. Eye care was performed at night.Consumption of sterile plain eye ointment 3.5 g (Lubratex): (lanolin content 10%, white platelet 80% and mineral oil 10%).CompanySina Daroo Tehran.Anti-allergic adhesive with width: 1/27.Company Sins Max</i_keyword>
      <i_keyword>Intervention group: Intervention group 1: Ointment and artificial tear. Ointment care :Every 6 hours by a trained nurse investigator in one of the patient's eyes about 2 cm of ointment in the inferior fornix from the inside out with the sterilization technique, so that about 1 cm of the ointment is poured out at the beginning of the ointment and Avoid contact with the patient's eye ointment and have the nurse thoroughly wash their hands as well as any ointment specific to the patient. After pouring the ointment, the patient's eyes are gently closed and checked every two hours by the nurse for the eyelid to be closed. Every 6 hours the patient's eyes are washed by the nurse with sterile water and cotton.Another patient's eye care was performed with artificial tears. That is, every 6 hours the nurse in charge trained by the researcher washes her hands and pours artificial tears into the other eye. For further care of the patient's eyes, the nurse is rinsed with sterile water and cotton, and the procedure is repeated again..Eye care was performed 3 times every 24 hours. Eye care was performed at night.Consumption of sterile plain eye ointment 3.5 g (Lubratex): (lanolin content 10%, white platelet 80% and mineral oil 10%).CompanySina Daroo Tehran.Sina Darou Tehran Artificial Tears</i_keyword>
      <i_keyword>Intervention group:anti-allergenic adhesive and artificial tear. Care with anti-allergic adhesive (1 / 25cm wide)Every 6 hours, the eyelid is closed with an anti-allergic adhesive with a width of 1.27. In such a way that one piece of adhesive is placed horizontally on the upper eyelid and the other piece is placed vertically on the patient's eyelid so that it rests on the patient's cheek and eyelid. Examines in terms of damage. If the adhesive needs to be renewed, this will be done. Every 6 hours the patient's eyes will be rinsed with sterile water and cotton and the eye care will be re-applie..Another patient's eye care was performed with artificial tears. That is, every 6 hours the nurse in charge trained by the researcher washes her hands and pours artificial tears into the other eye. For further care of the patient's eyes, the nurse is rinsed with sterile water and cotton, and the procedure is repeated again..Eye care was performed 3 times every 24 hours. Eye care was performed at night.Consumption of.Anti-allergic adhesive with width: 1/27.Company Sins Max and .Sina Darou Tehran Artificial Tears.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ocular keratitis. Timepoint: At the beginning of the study and on the seventh day. Method of measurement: Fluorescein Test.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-10</approval_date>
        <contact_name>Ethics committee of Yazd of Medical Sciences</contact_name>
        <contact_address>No. 5, Fifth Alley, Shahd Zinly Alley, Fajr Dahi Boulevard Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
