<?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>IRCT20181123041737N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-06</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Conventional and Pattern Scanning Pan retinal Photocoagulation Effects on Diabetic Patients' visual field</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Conventional and Pattern Scanning Pan retinal Photocoagulation Effects on Diabetic Patients' visual field</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35431</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In the present study, the patient, the resident (Evaluator)and the nurse are kept blind , but the physician conducting the PRP is aware.</study_design>
      <phase>N/A</phase>
      <hc_freetext>proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Twenty patients with proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy or one eye with proliferative diabetic retinopathy and the other with severe non-proliferative diabetic retinopathy, requiring PRP.One eye underwent the Conventional PRP . In Conventional PRP method, power 250-550 mW, spot-laser 200-500μ and pulse durations100ms were applied. Spot spacing was considered as half the spot size width. Intervention 2: Intervention group: Twenty patients with proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy or one eye with proliferative diabetic retinopathy and the other with severe non-proliferative diabetic retinopathy, requiring PRP. One eye underwent the  Pattern Scanning PRP. In the pattern scanning method, the power of 150-550 mW, the pulse duration of 10-30 ms, the 200 μm laser spot, and the laser spot spacing of 100 μm were applied.</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 can be shared

When:
6 months after the publication of the results

To whom:
Researchers working in academic institutions

Conditions:
The request for data is only after the publication of the results by persons working in academic institutions

Where to obtain:
atena.latifi
atena.latifi@yahoo.com

How to obtain:
after the publication of the results

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>atena latifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abbasi Ave.,Nikukari hospital</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5154645395</zip>
        <telephone>+98 41 3657 7330</telephone>
        <email>atena.latifi@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atena latifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abbasi Ave., Nikukari hospital</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5154645395</zip>
        <telephone>+98 41 3657 7330</telephone>
        <email>atena.latifi@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Proliferative diabetic retinopathy or severe non- proliferative diabetic retinopathy patients
Patients with informed consent
Patients with proper collaboration to perform a primetry</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with ocular infections
Glaucoma or uveitis patients
Patients with degenerative or inherited retinal disease which leads to visual field damage
Any ocular disease that impairs the performance of primetry
Lack of proper access to patient to follow up
Diabetic maculopathy
History of previous laser retinal treatment
turbid media</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Twenty patients with proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy or one eye with proliferative diabetic retinopathy and the other with severe non-proliferative diabetic retinopathy, requiring PRP.One eye underwent the Conventional PRP . In Conventional PRP method, power 250-550 mW, spot-laser 200-500μ and pulse durations100ms were applied. Spot spacing was considered as half the spot size width.</i_keyword>
      <i_keyword>Intervention group: Twenty patients with proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy or one eye with proliferative diabetic retinopathy and the other with severe non-proliferative diabetic retinopathy, requiring PRP. One eye underwent the  Pattern Scanning PRP. In the pattern scanning method, the power of 150-550 mW, the pulse duration of 10-30 ms, the 200 μm laser spot, and the laser spot spacing of 100 μm were applied.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Conventional  Pan retinal Photocoagulation Effects on Diabetic Patients visual field. Timepoint: One day prior to the PRP and one month after the initial PRP. Method of measurement: Humphrey 30-II SITA Standard perimetry.</prim_outcome>
      <prim_outcome>Pattern Scanning Pan retinal Photocoagulation Effects on Diabetic Patients visual field. Timepoint: One day prior to the PRP and one month after the initial PRP. Method of measurement: Humphrey 30-II SITA Standard perimetry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Visual acuity. Timepoint: One day prior to the PRP and one month after the initial PRP. Method of measurement: Snellen chart.</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>2018-06-25</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Abbasi Ave., Nikukari Hospital Tabriz West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
