<?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>IRCT20131229015975N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-27</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of horizontal rectus muscle weakening by lateral rectus muscle marginal myotomy with medial rectus muscle recession  in palpebral fissure height in duane retraction syndrome type1</public_title>
      <acronym></acronym>
      <scientific_title>The effect of horizontal rectus muscle weakening by lateral rectus muscle marginal myotomy with medial rectus muscle recession  in palpebral fissure height in duane retraction syndrome type1</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38239</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The selection of patients was easy and accessible among patients with type 1 duine syndrome referring to Feyz Hospital in Isfahan, which has acceptable criteria. The patients were randomly assigned to two groups based on chance chances. In the operating room, envelopes containing recession paper and myotomy were placed in front of the patient and the patient entered one of the intervention groups by selecting one of the envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Duane syndrome type1.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 14 patients diagnosed with ophthalmologist diagnosed with duine type 1 syndrome were selected to resolve the problem of eyelid narrowing, medial rectus medial intervention with marginal micectomy, and face-to-face factors (primary position), the vertical deviation of the affected eye in front of the eye, the degree of narrowing of the affected eyelid gap in front of the eye, and abnormal spinal rotation before, two weeks and three months after surgery, and it is registered. Intervention 2: Control group: 14 patients diagnosed with ophthalmologic diagnosis of type 1 duine syndrome were diagnosed and treated for rectus medication, and interventional rectus medication was used for solving the problem of eyelid narrowing. Primary position), the vertical deviation of the affected eye in front of the eye, the degree of narrowing of the affected eyelid gap in front of the eye and abnormal spinal rotation were measured and recorded before, two weeks and 3 months after surgery. .</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:
Individual data of the participants can be made available to applicants after being unidentifiable and two years after the publication of the results.

When:
Two years after the publication of the results

To whom:
Specialists and assistants of the Eye Surgery Group.

Conditions:
To compare the same method with the proposed method in this study

Where to obtain:
Send a clear request to dr_zandi@yahoo.com and with the permission of the research and student deputy of the Isfahan University of Medical Sciences.

How to obtain:
Send a clear request to dr_zandi@yahoo.com and with the permission of the research and student deputy of the Isfahan University of Medical Sciences.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Pourazizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezar Jarib Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>m.pourazizi@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Zandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezar Jarib Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>dr_zandi@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 1 Doyen syndrome based on diagnostic criteria: Restrictions on the horizontal movements of the eye, especially in abduction, eye drooping and eyedropic narrowing during up / down shoot of the eye during adduction.
Age of the patient is 5 years or more
The patient's age is 5 years or more.
The amount of distortion in the eye is less than 20 prisma diopters.
Need to weaken horizontal rectus muscles based on the diagnosis of an ophthalmologist
Patient Satisfaction to Participate in the Study</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of strabismus surgery
There is an abnormal edge of the eyelid
The presence of simultaneous neurological and chromosomal problems
Other synchronous eye pathologies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H01.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inflammation of eyelid, unspecified</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: 14 patients diagnosed with ophthalmologist diagnosed with duine type 1 syndrome were selected to resolve the problem of eyelid narrowing, medial rectus medial intervention with marginal micectomy, and face-to-face factors (primary position), the vertical deviation of the affected eye in front of the eye, the degree of narrowing of the affected eyelid gap in front of the eye, and abnormal spinal rotation before, two weeks and three months after surgery, and it is registered.</i_keyword>
      <i_keyword>Control group: 14 patients diagnosed with ophthalmologic diagnosis of type 1 duine syndrome were diagnosed and treated for rectus medication, and interventional rectus medication was used for solving the problem of eyelid narrowing. Primary position), the vertical deviation of the affected eye in front of the eye, the degree of narrowing of the affected eyelid gap in front of the eye and abnormal spinal rotation were measured and recorded before, two weeks and 3 months after surgery. .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The degree of deviation of the affected eye is in the face. Timepoint: Before surgery, two weeks and three months after surgery. Method of measurement: Clinical examination by the same surgeon.</prim_outcome>
      <prim_outcome>Vertical deviation of the affected eye in front of the eye. Timepoint: Before surgery, two weeks and three months after surgery. Method of measurement: Clinical examination by the same surgeon.</prim_outcome>
      <prim_outcome>The amount of narrowing of the affected eye lid in front of the eye. Timepoint: Before surgery, two weeks and three months after surgery. Method of measurement: Clinical examination by the same surgeon.</prim_outcome>
      <prim_outcome>Abnormal head rotation. Timepoint: Before surgery, two weeks and three months after surgery. Method of measurement: Clinical examination by the same surgeon and patient report or his parents.</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>2017-05-31</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jarib Ave. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
