<?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>IRCT20200317046804N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-05</date_registration>
      <primary_sponsor>Noor Eye Hospital</primary_sponsor>
      <public_title>Conventional and transepithelial PRK</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of conventional and transepithelial photorefractive keratectomy in myopic and myopic astigmatism patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46588</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization will be done using permuted-block randomization method and based on a block size of 4. The random sequence of blocks will be obtained from the random number table. In the first stage, patients will be assigned to one of the two intervention groups A and B, and in the second stage, it will be randomized to determine which eye will be operated on by transepithelial method. Allocation concealment  will be performed by sequentially numbered, sealed, opaque envelopesa, Blinding description: Patients are unaware of which group they are in. People who do the tests (optometrist and clinical ophthalmologist) will also be unaware of which intervention group they are evaluating.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Corneal epithelium debridement in Photorefractive keratectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Both patient's eyes underwent photorefractive keratectomy, but the method of corneal epithelial removal is different. In one eye, the epithelium is removed mechanically by the surgeon, and in the other eye, it is done by excimer laser device without the intervention of the surgeon's hand. Intervention 2: Intervention group 2: Both patient's eyes underwent photorefractive keratectomy, but the method of corneal epithelial removal is different. In one eye, the epithelium is removed using alcohol and by the surgeon, and in the other eye, it is done by excimer laser device without the intervention of the surgeon's hand.</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 There are no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Alvani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 96, Esfandiar Blvd, Valiasr Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1968653111</zip>
        <telephone>+98 21 8240 1631</telephone>
        <email>alvani63@gmail.com</email>
        <affiliation>Noor Eye Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seyed Hasan Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 96, Esfandiar Blvd, Valiasr Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1968653111</zip>
        <telephone>+98 21 8865 1515</telephone>
        <email>research@norc.ac.ir</email>
        <affiliation>Noor Eye Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Equivalent sphere at least -2.00 diopter with astigmatism up to -4.00 diopter and myopia up to -8.00 diopter.
The stability of refraction for at least one year before surgery.
Corrected visual acuity more than 20/30.
Contact lens use should be discontinued at least 3 weeks prior to surgery.
age between 18 to 50 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any ocular pathology including corneal dystrophy, keratoconus or keratoconus suspect and glaucoma or glaucoma suspect.
The history of diabetes and autoimmune diseases.
The history of any previous ocular surgery.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H17.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other corneal scars and opacities</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 1: Both patient's eyes underwent photorefractive keratectomy, but the method of corneal epithelial removal is different. In one eye, the epithelium is removed mechanically by the surgeon, and in the other eye, it is done by excimer laser device without the intervention of the surgeon's hand.</i_keyword>
      <i_keyword>Intervention group 2: Both patient's eyes underwent photorefractive keratectomy, but the method of corneal epithelial removal is different. In one eye, the epithelium is removed using alcohol and by the surgeon, and in the other eye, it is done by excimer laser device without the intervention of the surgeon's hand.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Corneal epithelial defect size. Timepoint: Day of operation and consecutive days after surgery until complete healing of corneal epithelial defect (at least 3 and up to 7 days). Method of measurement: Using photoslit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of patient's pain and discomfort due to corneal epithelial defect. Timepoint: Consecutive days after surgery until complete healing of corneal epithelial defect (at least 3 and up to 7 days). Method of measurement: 11-Point numeric scale of pain Questionnaire and Eye sensation scale Questionnaire.</sec_outcome>
      <sec_outcome>Non-corrected and corrected VA. Timepoint: Preoperation and 3 month after operation. Method of measurement: Snellen Chart.</sec_outcome>
      <sec_outcome>Refraction. Timepoint: Preoperation and 3 month after operation. Method of measurement: Autorefractometer.</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>Noor Eye Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-30</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Central Building of the University, Quds Street, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
