<?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>IRCT20220513054834N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-29</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>comparison of nylon versus vicryl sutures on conjunctival autografting in pterygium surgery</public_title>
      <acronym></acronym>
      <scientific_title>comparison of nylon versus vicryl sutures on conjunctival autografting in pterygium surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63558</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization with a block randomization list was
used to allocate patients to either vicryl or nylon suture
groups.Patients were unaware of the suture material
being used, but the surgeon and postoperative assessor
were not masked to the assignment.</study_design>
      <phase>2</phase>
      <hc_freetext>Pterygium.</hc_freetext>
      <i_freetext>Intervention 1: This study is a randomized clinical trial (RCT) in which 70 patients referred to Shahid Sadoughi Hospital who are eligible to enter and are candidates for pterygium surgery are divided into two groups of 35 people A and B. In group A, nylon sutures is used and in group B, vicryl sutures is used for conjunctival graft. Examination is performed on days 1, 7, 4 and 8 weeks after the operation in terms of the studied variables according to a questionnaire pre-determined by the ophthalmologist's assistant. The two groups are compared in terms of conjunctival redness, conjunctival chemosis, foreign body sensation, pain according to the VAS criterion, and the degree to which the sutures open. Intervention 2: This study is a randomized clinical trial (RCT) in which 70 patients referred to Shahid Sadoughi Hospital who are eligible to enter and are candidates for pterygium surgery are divided into two groups of 35 people A and B. In group A, nylon sutures is used and in group B, vicryl sutures is used for conjunctival graft. Examination is performed on days 1, 7, 4 and 8 weeks after the operation in terms of the studied variables according to a questionnaire pre-determined by the ophthalmologist's assistant. The two groups are compared in terms of conjunctival redness, conjunctival chemosis, foreign body sensation, pain according to the VAS criterion, and the degree to which the sutures open.</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:
Only part of the data contains the main consequences to be shared

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
It must be decided by the circumstances of the time

Where to obtain:
Request the email of the project manager.

How to obtain:
about a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>saeede akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beheshti Town - Soroush St. - Soroush 1/4</address>
        <city>شهرصنعتی بزرگ /شیراز</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>718936345</zip>
        <telephone>0731 360 4726</telephone>
        <email>saeede.light@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammadreza Shoja</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>daneshjoo blv</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2343545</zip>
        <telephone>0350898983</telephone>
        <email>saeede.light@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age more than 18
people with decreased vision or stigma more than 3D
Patients with complaints of apparent malformation of the pterygium</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>people with pseudo pterygium
people with collagen vascular sickness
people with Corneal dystrophy
people with sever dry eye
people with previous history of pterygium surgery
people with temporal pterygium</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>This study is a randomized clinical trial (RCT) in which 70 patients referred to Shahid Sadoughi Hospital who are eligible to enter and are candidates for pterygium surgery are divided into two groups of 35 people A and B. In group A, nylon sutures is used and in group B, vicryl sutures is used for conjunctival graft. Examination is performed on days 1, 7, 4 and 8 weeks after the operation in terms of the studied variables according to a questionnaire pre-determined by the ophthalmologist's assistant. The two groups are compared in terms of conjunctival redness, conjunctival chemosis, foreign body sensation, pain according to the VAS criterion, and the degree to which the sutures open.</i_keyword>
      <i_keyword>This study is a randomized clinical trial (RCT) in which 70 patients referred to Shahid Sadoughi Hospital who are eligible to enter and are candidates for pterygium surgery are divided into two groups of 35 people A and B. In group A, nylon sutures is used and in group B, vicryl sutures is used for conjunctival graft. Examination is performed on days 1, 7, 4 and 8 weeks after the operation in terms of the studied variables according to a questionnaire pre-determined by the ophthalmologist's assistant. The two groups are compared in terms of conjunctival redness, conjunctival chemosis, foreign body sensation, pain according to the VAS criterion, and the degree to which the sutures open.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Untie the knot. Timepoint: Examination is performed on the 1st, 7th, 4th and 8th week after the operation in terms of the studied variables according to a questionnaire pre-determined by the ophthalmologist's assistant. Method of measurement: visual analogue scale questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Eye redness. Timepoint: Examination is performed on the 1st, 7th, 4th and 8th week after the operation in terms of the studied variables according to a questionnaire pre-determined by the ophthalmologist's assistant. Method of measurement: As an observation.</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>2022-05-02</approval_date>
        <contact_name>Ethic committee of yazd university of medical sciences</contact_name>
        <contact_address>Yazd, Shahid Bahonar Square Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
