<?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>IRCT20190129042551N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-13</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>study of high order aberrations in pterygium surgery</public_title>
      <acronym></acronym>
      <scientific_title>a comparative study of fibrin glue versus suturing on higher order aberration in patients undergoing pterygium excision and free conjunctival autograft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37309</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pterygium.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:after general anesthesia, fibrovascular tissue will be removed and the surface of the cornea will be shaved by razor blade.then the conjunctivolimbal autograft will be taken from conjunctival area of the upper bulb.this outograft will be placed in the desired location by 10-0 nylon suture.after surgery patients will be treated by Betamethasone drop (every 4 hour) and chloramphenicol drop (QID) and Artificial tear drop(every 3 hour) and betamethasone drop drop will be tapered every 2 weeks.aberrometry of patients will be measured before and 6 months after surgery by pantacam. Intervention 2: Intervention group 2:after general anesthesia, fibrovascular tissue will be removed and the surface of the cornea will be shaved by razor blade.then the conjunctivolimbal autograft will be taken from conjunctival area of the upper bulb.this outograft will be placed in the desired location by fibrin glue.after surgery patients will be treated by Betamethasone drop (every 4 hour) and chloramphenicol drop (QID) and Artificial tear drop(every 3 hour) and betamethasone drop drop will be tapered every 2 weeks..aberrometry of patients will be measured before and 6 months after surgery by pantacam.</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 is shared after the identities of the study subjects are unrecognizable

When:
Accessing datas starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
The relevance of the applicant's field to the study , for example, being a physician, having a justified reason for accessing the data of individuals, accessing the data only for the purpose of obtaining further information on the study, the individual's commitment not to Misuse of people's data

Where to obtain:
nikookari hospital , cornea clinic , dr nazli taheri
nikookari hospital , office of research assistance

How to obtain:
Authentication of the data requesting person, having a scientific and justifiable reason for accessing the data and presenting it to the hospital research assistant, specifying the amount of data access, confirming the research assistant, referring to the person in charge of the research, Dr. Nazli Taheri, Approved by Dr. Taheri

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>aminreza deljooy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8 , 2nd alley.,lida street.,valiasr town</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5157844333</zip>
        <telephone>+98 41 3331 3959</telephone>
        <email>timman.med1994@gmal.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>aminreza deljooy</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8 , 2nd alley.,lida street.,valiasr town</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5157844333</zip>
        <telephone>+98 41 3331 3959</telephone>
        <email>timman.med1994@gmal.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with pterygium that have surgical indication</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of pterygium surgery
History of Anterior Segment Surgery
Chronic use of eye drops
Corneal Diseases
using contact lens
Active intraocular inflammation
Recent Ophthalmic Trauma
dry eye</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H11.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pterygium of eye</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:after general anesthesia, fibrovascular tissue will be removed and the surface of the cornea will be shaved by razor blade.then the conjunctivolimbal autograft will be taken from conjunctival area of the upper bulb.this outograft will be placed in the desired location by 10-0 nylon suture.after surgery patients will be treated by Betamethasone drop (every 4 hour) and chloramphenicol drop (QID) and Artificial tear drop(every 3 hour) and betamethasone drop drop will be tapered every 2 weeks.aberrometry of patients will be measured before and 6 months after surgery by pantacam.</i_keyword>
      <i_keyword>Intervention group 2:after general anesthesia, fibrovascular tissue will be removed and the surface of the cornea will be shaved by razor blade.then the conjunctivolimbal autograft will be taken from conjunctival area of the upper bulb.this outograft will be placed in the desired location by fibrin glue.after surgery patients will be treated by Betamethasone drop (every 4 hour) and chloramphenicol drop (QID) and Artificial tear drop(every 3 hour) and betamethasone drop drop will be tapered every 2 weeks..aberrometry of patients will be measured before and 6 months after surgery by pantacam.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>High order aberrations. Timepoint: The beginning of the intervention and 6 months after the surgery. Method of measurement: pentacam device.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-20</approval_date>
        <contact_name>Ethics Committee in Research, Tabriz University of Medical Sciences</contact_name>
        <contact_address>No.8 , 2th alley , new lida , valiasr town tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
