<?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>IRCT20180902040928N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-05</date_registration>
      <primary_sponsor>Basir eye health research center</primary_sponsor>
      <public_title>Pretreatment with topical betamethasone in ahmed glaucoma valve implantation</public_title>
      <acronym></acronym>
      <scientific_title>Pretreatment with topical betamethasone in ahmed glaucoma valve implantation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33663</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified block randomization was performed. We divided eyes into 2 subgroups as follow: group 1: patients undergone previous failed antiglaucoma surgery, group 2: patients without previous antiglaucoma surgery.
In each subgroup, eyes are randomly assigned to the study arms using random blocks: totally 108 patients were enrolled dividing into 2 groups of conventional Ahmed Glaucoma Valve (AGV) implantation (group A, 54 eyes), Ahmed Glaucoma Valve (AGV) with pre-operative dropped betamethasone (group B, 54 eyes), Blinding description: participants and data analyser were blinded in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Glaucoma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: pre-treatment with betamethasone eye drop 1% from 3 days before surgery until the time of surgery, 6 times a day in patients candidate for insertion of Ahmed valve in supra temporal area of eye. Intervention 2: Control group: conventional insertion of Ahmed valve in supra temporal area of eye without pre-treatment betamethasone prescription.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Results will be shown in terms of published articles</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Yadegari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461783381</zip>
        <telephone>+98 21 6694 0404</telephone>
        <email>sobhanisoheila@yahoo.com</email>
        <affiliation>Basir eye health research center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Yadegari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461783381</zip>
        <telephone>+98 21 6694 0404</telephone>
        <email>sobhanisoheila@yahoo.com</email>
        <affiliation>Basir eye health research center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with no age limit with IOPs less than target pressure in whom glaucoma drainage implant (GDI) surgery was planned were enrolled in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria were no light perception at baseline
history of ocular surface infection in recent two weeks
pregnancy
breast feeding
lack of healthy conjunctiva for AGV insertion
sensitivity to betamethasone eye drop</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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: pre-treatment with betamethasone eye drop 1% from 3 days before surgery until the time of surgery, 6 times a day in patients candidate for insertion of Ahmed valve in supra temporal area of eye</i_keyword>
      <i_keyword>Control group: conventional insertion of Ahmed valve in supra temporal area of eye without pre-treatment betamethasone prescription</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intraocular pressure. Timepoint: first day, first week, month 1, 3, 6, 9 and 12 after the surgery. Method of measurement: Goldman applanation tonometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of eyes requiring medications. Timepoint: first day, first week, month 1, 3, 6, 9 and 12 after the surgery. Method of measurement: Quantitative.</sec_outcome>
      <sec_outcome>Number of medications. Timepoint: first day, first week, month 1, 3, 6, 9 and 12 after the surgery. Method of measurement: Quantitative.</sec_outcome>
      <sec_outcome>Best corrected visual acuity (BCVA). Timepoint: first day, first week, month 1, 3, 6, 9 and 12 after the surgery. Method of measurement: tumbling E-chart.</sec_outcome>
      <sec_outcome>Complications. Timepoint: first day, first week, month 1, 3, 6, 9 and 12 after the surgery. Method of measurement: qualitative.</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>No funding source is applicable</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-28</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
