<?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>IRCT20180428039441N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-27</date_registration>
      <primary_sponsor>Noor Eye hospital</primary_sponsor>
      <public_title>Steroid after PRK</public_title>
      <acronym>-</acronym>
      <scientific_title>Short versus long term topical steroid effect on corneal haze incidence after photorefractive keratectomy with mitomycin-C</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>222</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31800</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: -, Randomization description: Randomization will be done using permuted-block randomization method. In addition to balancing the number of people between the three groups, this method It can prevent the prediction of intervention sequence. Blocks random sequence will be provided by STATA software. In order to maintenance of allocation concealment, full report will be published after completion of the study, Blinding description: Patients will be unaware of which group (intervention or placebo) they are in. Also, those who perform the tests (optometrists and the clinical ophthalmologist responsible for corneal opacity diagnosis) will also be unaware of which group (intervention or placebo) is evaluating.</study_design>
      <phase>3</phase>
      <hc_freetext>Corneal haze after photorefractive keratectomy.</hc_freetext>
      <i_freetext>Intervention 1: 1. Control group: Participants who will receive topical steroid after PRK for 3 months. A one week of Betamethasone 0.1% and 11 weeks of tapering Fluorometholone 0.1% (FML). Intervention 2: 2. Intervention group: Participants who will receive topical steroid after PRK for 2 months. A one week of Betamethasone 0.1% and 7 weeks of tapering Fluorometholone 0.1% (FML). Intervention 3: 3. Intervention group: Participants who will receive topical steroid after PRK for 1 months. A one week of Betamethasone 0.1% and 3 weeks of tapering Fluorometholone 0.1% (FML).</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 Per request, we will decide about the dissemination of the data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojgan Pakbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>96, Esfandiar Blvd, Valiasr St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1968653131</zip>
        <telephone>+98 21 8240 1675</telephone>
        <email>m_pakbin@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hassan Hashemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>96, Esfandiar Blvd, Valiasr St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1968653131</zip>
        <telephone>+98 21 8240 1675</telephone>
        <email>research@norc.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>PRK candidates in following criteria
Age: 21-40 years
Spherical Equivalent (SE): 0 to -6.00 Diopter
Astigmatism: equal to -2.00 D or less
Best corrected visual acuity (BCVA): 20/25 or better
Patient's desire to participate in study and post-operative follow-ups
Discontinuing soft contact lenses using 1 week and hard contact lenses 3 weeks before first examination
Steady refractive errors (change &lt; 0.5 dioptre) during a year before photorefractive keratectomy</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy, breastfeeding or pregnancy planning during the study period
Using corticosteroid medications (topical or systemic) that interfere with the recovery process
Systemic diseases such as diabetes or Thyroid disease
Glaucoma or intraocular pressure greater than 21 mm Hg
Keratoconus, any corneal irregularity or opacity
Untreated Blepharitis or MGD (meibomian gland dysfunction)
Ocular surgery history</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 - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1. Control group: Participants who will receive topical steroid after PRK for 3 months. A one week of Betamethasone 0.1% and 11 weeks of tapering Fluorometholone 0.1% (FML).</i_keyword>
      <i_keyword>2. Intervention group: Participants who will receive topical steroid after PRK for 2 months. A one week of Betamethasone 0.1% and 7 weeks of tapering Fluorometholone 0.1% (FML).</i_keyword>
      <i_keyword>3. Intervention group: Participants who will receive topical steroid after PRK for 1 months. A one week of Betamethasone 0.1% and 3 weeks of tapering Fluorometholone 0.1% (FML).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Corneal haze score. Timepoint: Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery. Method of measurement: Slit lamp biomicroscopy (BD 900, Haag-Streit AG, Koeniz, Switzerland.</prim_outcome>
      <prim_outcome>Corneal densitometry. Timepoint: Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery. Method of measurement: Pentacam (Oculus Optikgeräte GmbH, Wetzlar, Germany).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Myopic regression. Timepoint: Before photorefractive keratectomy, 1,3, 6 and 12 months after surgery. Method of measurement: Topcon auto-refractometer (Topcon KR 8000, Topcon Corporation Tokyo, Japan)- Trial frame- NIDEK chart projector (CPe670, 20/10–20/400; Nidek Co., Gamagori, Japan).</sec_outcome>
      <sec_outcome>Contrast sensitivity. Timepoint: Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery. Method of measurement: CSV1000 contrast sensitivity chart (VectorVision, Dayton, OH).</sec_outcome>
      <sec_outcome>Intraocular pressure. Timepoint: Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery. Method of measurement: Applanation Tonometer- Slit lamp biomicroscope (BD 900, Haag-Streit AG, Koeniz, Switzerland).</sec_outcome>
      <sec_outcome>Corneal aberrations. Timepoint: Before photorefractive keratectomy, 1, 3, 6 and 12 months after surgery. Method of measurement: Pentacam.</sec_outcome>
      <sec_outcome>Unncorrected visual acuity. Timepoint: Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery. Method of measurement: NIDEK chart projector (CPe670, 20/10–20/400; Nidek Co., Gamagori, Japan).</sec_outcome>
      <sec_outcome>Best corrected visual acuity. Timepoint: Before photorefractive keratectomy, 1,2, 3, 6 and 12 months after surgery. Method of measurement: Trial frame- NIDEK chart projector (CPe670, 20/10–20/400; Nidek Co., Gamagori, Japan).</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>2618-07-18</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>University Central Building,Ghods St, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
