<?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>IRCT20220601055053N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-20</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>Oral Vitamin_C Effect in Treatment of Cornea</public_title>
      <acronym></acronym>
      <scientific_title>Oral Ascorbate Effect on Corneal Epithelial Healing Time and Haze Formation After Trans_epithelial Photorefractive Keratectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63913</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The patients are randomly divided into two groups using BLOCK RANDOMIZATION method by the surgical technician(that is present in all surgeries) and the surgeon is not aware of the patients'placement in each group.The patients will be randomly divided into equal numbers by computer.From this number , groupA as case control will only receive the common treatment after the surgery which includes using betamethasone and chloramphenicol drops, 1drop every 6hours till the first week after surgery and fluocort drop till 10 weeks after surgery(reducing dose after every 2weeks).groupB as intervention group will receive oral tablets of vitamin C 500mg every 6hours during the first three days after surgery along with the common treatment.It is necessary to mention that the patients will be explained that they don't need to use any other combinations including vitamin C, Blinding description: The patients are randomly divided into two groups with equal number of patients by computer using BLOCK RANDOMIZATION method by the surgical technician(that is present in all surgeries) and the surgeon and the researcher are not aware of the patients'placement in each group.</study_design>
      <phase>3</phase>
      <hc_freetext>Effect of Ascorbate on Healing Cornea Epithelium after Trans_epithelial Photorefractive Keratectomy.</hc_freetext>
      <i_freetext>Intervention 1: Control group: they will only receive the common treatment after the surgery which includes using bethamethasone and cloramphenicole drops, 1drop every 6hours till the first week after surgey and flucort drop till 10 weeks after surgery(reducing dose after every 2weeks). Intervention 2: Intervention group: they will receive oral chewing tablets of vitamin C 500 mg produced by Simorgh Daru Attar Pharmaceutical indaustry every 6hours during the first three days after surgery along with the common treatment.</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 This survey is such a statistical analysis and our purpose is releasing the inclusion in group results.Personal identities and personal results of patients are unnecessary.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloofar Hejazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz University of Medical sciences, Edari district. North taleghani Blvd., Taleghani square</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3155734541</zip>
        <telephone>+98 26 3254 8630</telephone>
        <email>niloohjz7@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Niloofar Hejazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alborz University of Medical sciences, Edari district. North taleghani Blvd., Taleghani square</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3155734145</zip>
        <telephone>+98 26 3254 8630</telephone>
        <email>niloohjz7@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients Candidated for TPRK during the 2022, June
Patients' eye score must be stable for at least one year
Patients must be more than 18 and less than 50 years old
Because this surgery is completely elective,both this surgery and using vitamin_c must be based on the patient's decisions</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patients were not interested in participating the study despite the comprehensive and complete explanations.
The patient is dead or get another proved disease such as collagen vascular diseases,romatoid arthritis,glandular diseases (hypo/hyper thyroidism and hypo/hyper parathyroidism),diabetes mellitus,hypertension,marfan syndrome,herpes keratitis,infectious diseases(HIV,hepatitis),cataract or any other past noticable ophthalmic disease or surgery that destroy the results of study in a way that examination can not be compared and assessed.</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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: they will only receive the common treatment after the surgery which includes using bethamethasone and cloramphenicole drops, 1drop every 6hours till the first week after surgey and flucort drop till 10 weeks after surgery(reducing dose after every 2weeks).</i_keyword>
      <i_keyword>Intervention group: they will receive oral chewing tablets of vitamin C 500 mg produced by Simorgh Daru Attar Pharmaceutical indaustry every 6hours during the first three days after surgery along with the common treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Corneal Epithelial Healing Time. Timepoint: Before the surgery,1week, 2weeks, first, second, third months after surgery. Method of measurement: slit lamp.</prim_outcome>
      <prim_outcome>Corneal Haze Formation. Timepoint: Before the surgery,1week, 2weeks, first, second, third months after surgery. Method of measurement: slit lamp.</prim_outcome>
      <prim_outcome>Crneal Epithelial Healing Quality. Timepoint: Before the surgery,1week, 2weeks, first, second, third months after surgery. Method of measurement: slit lamp.</prim_outcome>
      <prim_outcome>The Quantity of Patient's Pain after Surgery. Timepoint: Before the surgery,1week, 2weeks, first, second, third months after surgery. Method of measurement: The McGill Pain Questionnaire(MPQ).</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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-21</approval_date>
        <contact_name>Ethics committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>Alborz University of Medical sciences, Edari district. North taleghani Blvd., Taleghani square Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
