<?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>IRCT20190909044735N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-20</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Trabeculectomy surgery study with Vicryl scleral flap sutures</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of trabeculectomy with absorbable scleral flap sutures with trabeculectomy with releasable sutures in glaucoma patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43097</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects were randomly divided into two groups according to the four-way random permutations method. For example, if our blocks are 4, we have 6 blocks of AABB, ABAB, ABBA, BAAB, BAAB, BBAA, where we have to select n by dividing the 4 th sample by placement and thus obtain a randomization sequence. Randomization was achieved using WWW.sealedenvelope.com.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Glaucoma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In trabeculectomy surgery scleral flap should be fixed with two sutures. In this group we use absorbable sutures from Vicryl that does not require postoperative suture removal. Intervention 2: Control group: Scleral flap sutures are as usual made from nylon, this sutures are releasable and should be removed in postoperative examinations.</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:
Results of clinical examination after trabeculectomy in both case and control groups included intraocular pressure, visual acuity, anterior chamber depth changes, and any benefits or complications of trabeculectomy.

When:
After the publication of the paper resulting from this research

To whom:
Scholars who have access to the published article

Conditions:
Copyright

Where to obtain:
To the database of the journal in which the article is published

How to obtain:
Refer to the journal's website and access the article according to the journal's terms

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereidoon Farahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ophthalmology Department, Imam Khomeini hospital,  24 meter street,</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>616193743954</zip>
        <telephone>+98 916 111 1328</telephone>
        <email>farahi-f@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fereidoon Farahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ophthalmology Department, Imam Khomeini Hospital, 24 meter street.</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>616193743954</zip>
        <telephone>+98 916 111 1328</telephone>
        <email>farahi-f@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>glaucoma patients referred to the ophthalmology center of Imam Khomeini Hospital in Ahwaz
with indication of trabeculectomy for intraocular pressure control
In these patients, intraocular pressure does not reach the target level with medication</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of any intraocular surgery except cataract surgery
history of extensive conjunctival injury
use of antimetabolite or corticosteroid drugs
History of collagenvascular disease
History of uveitis, endophthalmitis or any ocular inflammation
History of secondary glaucoma, congenital or neovascular glaucoma
Black patients
Patients with thin sclera</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Glaucoma</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: In trabeculectomy surgery scleral flap should be fixed with two sutures. In this group we use absorbable sutures from Vicryl that does not require postoperative suture removal.</i_keyword>
      <i_keyword>Control group: Scleral flap sutures are as usual made from nylon, this sutures are releasable and should be removed in postoperative examinations.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post operative intraocular pressure. Timepoint: Intraocular pressure levels before surgery, morning after surgery, 3 days, one week, 2 weeks, 6 weeks and 3 months after surgery,. Method of measurement: The intraocular pressure will be measured by Goldman applan tonometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Visual Acuity. Timepoint: postop day 7, 14 and 21. Method of measurement: Snellen.</sec_outcome>
      <sec_outcome>Ocular ant chamber depth. Timepoint: postop day 1. Method of measurement: with slit lamp examination.</sec_outcome>
      <sec_outcome>Other possible complications of trabeculectomy. Timepoint: Morning after surgery, 3 days, one week, 2 , 6 weeks and 3 months after surgery. Method of measurement: in postop examination with slitlamp.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-19</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Research</contact_name>
        <contact_address>No.4, Ground Floor, Vice Chancellor for Research and Technology Development, Ahwaz Jundishapur University of Medical Sciences Ahwaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
