<?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>IRCT138710271555N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2009-02-01</date_registration>
      <primary_sponsor>The Filatov Institute of Eye Diseases and Tissue Therapy</primary_sponsor>
      <public_title>Excimer laser phototherapeutic keratectomy in treatment of post-burn persistent corneal ulcers</public_title>
      <acronym></acronym>
      <scientific_title>Excimer laser phototherapeutic keratectomy vs surgical keratectomy in treatment of post-burn persistent corneal epithelial defects with ulceration</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/850</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: In the main group (phototherapeutic keratectomy) all patients, which will fit the inclusion criteria mentioned above, will be included prospectively. In the control group (surgical keratectomy) patients, which will fit the inclusion criteria mentioned above, will be included retrospectively on the basis of case histories analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>post-burn corneal defect with ulceration.</hc_freetext>
      <i_freetext>excimer laser phototherapeutic keratectomy.</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>Mr Oleksiy Buznyk</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Frantsuzkyi bulvar 49/51</address>
        <city>Odessa</city>
        <country1>Ukraine</country1>
        <zip>65061</zip>
        <telephone>+380482636729</telephone>
        <email>ojogi_glaz@te.net.ua</email>
        <affiliation>The Filatov Institute of Eye Diseases and Tissue Therapy</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mr Oleksiy Buznyk</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Frantsuzkyi bulvar 49/51</address>
        <city>Odessa</city>
        <country1>Ukraine</country1>
        <zip>65061</zip>
        <telephone>+380482636729</telephone>
        <email>ojogi_glaz@te.net.ua</email>
        <affiliation>The Filatov Institute of Eye Diseases and Tissue Therapy</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Ukraine</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria - presence of post-burn corneal epithelial defect with ulceration, non-decreased size of post-burn corneal defect during 10 days of conventional treatment&#13;
   Exclusion criteria - corneal defect of other than burn etiology, post-burn corneal defect with edge(edges) connected with the limbus and adjacent area of necrosis of perilimbal conjunctiva, deep post-burn corneal ulceration</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H 16.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Corneal ulcer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>excimer laser phototherapeutic keratectomy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Speed of corneal epithelialization. Timepoint: 6 months. Method of measurement: Number of days after operation which was necessary to get corneal epithelialization. Corneal epithelialization it is absence of corneal staining after fluorescein test.</prim_outcome>
      <prim_outcome>Corneal epithelialization rate. Timepoint: 6 months. Method of measurement: Ratio of number of successful corneal epithelializations to number of operations.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Visual acuity. Timepoint: 6 months. Method of measurement: Golovin-Sivtsev chart for measurement of visual acuity.</sec_outcome>
      <sec_outcome>Recurrence rate. Timepoint: 6 months. Method of measurement: Ratio of number of corneal defect recurrences to number of successful corneal epithelializations.</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>The Filatov Institute of Eye Diseases and Tissue Therapy</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-11-07</approval_date>
        <contact_name>The Bioethics Committee of the Filatov Institute of Eye Diseases and Tissue Therapy</contact_name>
        <contact_address>Frantsuzkyi bulvar 49/51 Odessa  Ukraine</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
