<?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>IRCT20200217046523N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-18</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Preventive Effects of Ketorolac and Nephaazolin- Anthrazoline Drops on Reducing Patient's Ocular Complications</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation on the Preventive Effects of Ketorolac and Nephaazolin- Anthrazoline Drops on Reducing Patient's Ocular Complications after Phacoamulsification Surgery under sedation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47208</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (for example, top or bottom) and the researcher's second default is to consider even numbers for group 1 and odd numbers for group 2.
  The researcher begins to read the numbers in a predetermined manner and the patients are divided into two groups, Blinding description: In this study, patients will be assigned to two groups. Patients are not relieved of the drug content they receive because the appearance of all medications is the same. Clinical caregivers who give medications to patients also did not know what medication to give. After the course of treatment, to assess the effectiveness of the medication, the assessor does not know which patient has been treated with what medication and only fills in the information related to the questionnaires.</study_design>
      <phase>3</phase>
      <hc_freetext>Cataract.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Receiver of ketorolac. Calm retention will be the same in all patients with midazolam 0.04 kg / mg and fentanyl 1.5 mg / kg. In this group, 2 drops of ketorolac are instilled into the eyes of patients every 6 hours. After 5 minutes, 0.5% tetracycline drops are instilled in both groups, then the eyes are swollen and puffy, and the surgeon will cover the field with phycoamulsification surgery. The patient's operation is transferred to recovery. The patient's eye complaints such as burning, itchy eyes, pain and severity of pain (according to VAS criteria) every 15 minutes in the recovery unit and in the ward every half hour until discharge from the hospital and the patient's satisfaction based on Likert criteria before discharge from the hospital. The study is evaluated and registered by an uninformed witness. Intervention 2: Intervention group2: Naphazoline-antazoline drug recipient. Calm retention will be the same in all patients with midazolam 0.04 kg / mg and fentanyl 1.5 mg / kg. In this group, 2 drops of Naphazoline-antazolin are instilled into the eyes of patients every 6 hours. After 5 minutes, 0.5% tetracycline drops are instilled in both groups, then the eyes are swollen and puffy, and the surgeon will cover the field with phycoamulsification surgery. The patient's operation is transferred to recovery. The patient's eye complaints such as burning, itchy eyes, pain and severity of pain (according to VAS criteria) every 15 minutes in the recovery unit and in the ward every half hour until discharge from the hospital and the patient's satisfaction based on Likert criteria before discharge from the hospital. The study is evaluated and registered by an uninformed witness.</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 potential data can be shared after people have not been identified

When:
From 2021

To whom:
Researchers working in academic and scientific institutions

Conditions:
Free and on Web
Individuals can use the documents by visiting the research sites and the website of Isfahan University of Medical Sciences

Where to obtain:
Free and on Web.
Individuals can use the documents by visiting the website of Isfahan University of Medical Sciences and submitting an application

How to obtain:
Free and on Web

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Shetai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Feyz hospial, Feyz Ave,. Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673118</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>hamidshetabi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Shetai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Feyz hospial, Feyz Ave,. Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673118</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>hamidshetabi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All of the Patients undergoing Phacoamulsification Surgery under sedation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with glaucoma, uncontrolled hypertension, kidney disease, allergies to sedatives or studied
Proven psycho-anxiety disorders
Inability to follow up patients up to 0.5 hours after recovery
History of allergy or allergic reaction to Sedatives or studies
Any sensitivity to ketorolac</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Age-related cataract</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 group1: Receiver of ketorolac. Calm retention will be the same in all patients with midazolam 0.04 kg / mg and fentanyl 1.5 mg / kg. In this group, 2 drops of ketorolac are instilled into the eyes of patients every 6 hours. After 5 minutes, 0.5% tetracycline drops are instilled in both groups, then the eyes are swollen and puffy, and the surgeon will cover the field with phycoamulsification surgery. The patient's operation is transferred to recovery. The patient's eye complaints such as burning, itchy eyes, pain and severity of pain (according to VAS criteria) every 15 minutes in the recovery unit and in the ward every half hour until discharge from the hospital and the patient's satisfaction based on Likert criteria before discharge from the hospital. The study is evaluated and registered by an uninformed witness</i_keyword>
      <i_keyword>Intervention group2: Naphazoline-antazoline drug recipient. Calm retention will be the same in all patients with midazolam 0.04 kg / mg and fentanyl 1.5 mg / kg. In this group, 2 drops of Naphazoline-antazolin are instilled into the eyes of patients every 6 hours. After 5 minutes, 0.5% tetracycline drops are instilled in both groups, then the eyes are swollen and puffy, and the surgeon will cover the field with phycoamulsification surgery. The patient's operation is transferred to recovery. The patient's eye complaints such as burning, itchy eyes, pain and severity of pain (according to VAS criteria) every 15 minutes in the recovery unit and in the ward every half hour until discharge from the hospital and the patient's satisfaction based on Likert criteria before discharge from the hospital. The study is evaluated and registered by an uninformed witness</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ocular Complaints. Timepoint: Every 15 minutes in the recovery unit and in the ward for half an hour until discharge from the hospital. Method of measurement: Questionnaire.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-01</approval_date>
        <contact_name>Ethics committee of IsfahanUniversity of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
