xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05973253</url>
    </required_header>
    <id_info>
      <org_study_id>IR.MUI.MED.REC.1402.114</org_study_id>
      <nct_id>NCT05973253</nct_id>
    </id_info>
    <brief_title>Evaluation of Efficacy and Safety of Topical 1% Medroxyprogesterone in the Corneal Epithelium Healing After PRK</brief_title>
    <official_title>Evaluation of Efficacy and Safety of Topical 1% Medroxyprogesterone in the Corneal Epithelium Healing After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2023</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Isfahan University of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Isfahan Ophthalmology Research Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Isfahan University of Medical Sciences</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this clinical trial, it is decided that 30 patients who are candidates for photorefractive&#xD;
        keratectomy will receive a drop of prepared medroxyprogesterone randomly in one of their&#xD;
        eyes, in addition to the routine antibiotic drop that is normally placed at the end of the&#xD;
        procedure. Afterward, a bandage contact lens will be applied to both eyes, and the patients&#xD;
        will receive routine post-procedure drops, including betamethasone and ciprofloxacin drops&#xD;
        for both eyes. On the first, second, third, fourth, and fifth days after the operation, the&#xD;
        patients will be examined, and the size of the epithelial defect in both eyes will be&#xD;
        assessed using a slit lamp device. Additionally, the patients' pain levels in each eye will&#xD;
        be evaluated using a questionnaire.&quot;&#xD;
  &#xD;
        The main question is: General purpose:&#xD;
  &#xD;
        Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the&#xD;
        corneal epithelium after photorefractive keratectomy (PRK)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients who have referred for refractive surgery to correct myopia and myopia-stigmatism&#xD;
        first undergo complete examinations that are required before the procedure, which includes&#xD;
        the following examinations:&#xD;
  &#xD;
          1. manifest and cycloplegic refraction&#xD;
  &#xD;
          2. UCVA and BCVA&#xD;
  &#xD;
          3. Pentacam(topographic imaging)&#xD;
  &#xD;
          4. Examining the anterior and posterior segments of the eye with a slit lamp device Placed.&#xD;
             Then, on the day of the surgery, in the refractive surgery operating room, the eyes are&#xD;
             prepared . Anesthetizing drops of enstocaine are poured into the eyes. After removing&#xD;
             the corneal epithelium, laser ablation is performed using the Technolas Teneo 317&#xD;
             device, and then mitomycin C is placed on the cornea based on the amount of ablation and&#xD;
             then washed. At the end of the procedure, a contact lens bandage is placed on the eyes,&#xD;
             and then a drop of the antibiotic ciprofloxacin is poured into the eyes. At this stage,&#xD;
             a 1% medroxyprogesterone drop will be randomly poured into one of the eyes. After&#xD;
             discharge, ciprofloxacin and betamethasone drops are routinely prescribed for the&#xD;
             patient every 4 hours, and the patient returns for examination on the day after the&#xD;
             operation and on the third and fifth days after the operation. (7) In each visit, the&#xD;
             size of the corneal epithelial defect is measured by an ophthalmologist with a slit lamp&#xD;
             examination as the largest length of the defect and the largest perpendicular length in&#xD;
             millimeters. (2) Regarding the patient's pain and discomfort, a questionnaire is used to&#xD;
             score the pain intensity by the patient (0: no pain, 1: mild pain, 2: moderate pain, 3:&#xD;
             severe pain, 4: unbearable pain). (8) and the checklist includes information: pain&#xD;
             intensity, optical size Defect, gender, age, ablation rate, and refractive error will be&#xD;
             checked and recorded.&#xD;
  &#xD;
        The patient and the examiner do not know about the eye in which medroxyprogesterone drops&#xD;
        were used at the end of the procedure.&#xD;
  &#xD;
        Medroxyprogesterone drops are made by a pharmacologist under sterile conditions and delivered&#xD;
        the day before the operation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 21, 2023</start_date>
    <completion_date type="Actual">July 6, 2023</completion_date>
    <primary_completion_date type="Actual">June 21, 2023</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the corneal epithelium after photorefractive keratectomy (PRK)</measure>
      <time_frame>3 months</time_frame>
      <description>Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the corneal epithelium after photorefractive keratectomy (PRK)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">74</enrollment>
    <condition>Photorefractive Keratectomy</condition>
    <arm_group>
      <arm_group_label>eyes that recieved medroxy progestrone at the end of surgery</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>eyes that received one drop of medroxy progesterone at the end of the photorefractive keratectomy(PRK)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>eyes did not recieved moderxy progestrone</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>eyes that did not receive drop medroxy progesterone at the end of photorefractive keratectomy(PRK)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>prepared drop of medroxy progestrone acetat 1%</intervention_name>
      <description>In 37 patients who are candidates for photorefractive keratectomy, at the end of the procedure, in one eye randomly, in addition to the antibiotic drop that is routinely placed at the end of the procedure, a drop of prepared medroxyprogesterone is also placed. Then, a bandage contact lens is placed on the eyes, and the patient receives the routine post-procedure drops that include betamethasone and ciprofloxacin drops for both eyes.</description>
      <arm_group_label>eyes that recieved medroxy progestrone at the end of surgery</arm_group_label>
      <other_name>depo provera</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1- Age above 18 years 2- Myopia and myopic astigmatism 3- The stability of the&#xD;
               patient's refraction over the past year 4-- Not using contact lenses at least 3 weeks&#xD;
               before the operation 5- Absence of history of KCN and any type of corneal ectasia in&#xD;
               the patient himself or his first degree family 6- Full satisfaction and knowledge of&#xD;
               patients to enter the plan 7- No history of previous eye surgery and eye trauma 8-&#xD;
               Absence of active eye diseases, corneal dystrophy, retinal diseases, glaucoma, dry&#xD;
               eyes of any degree.&#xD;
  &#xD;
               9- Absence of systemic diseases that can potentially interfere with wound healing,&#xD;
               including diabetes, vascular collagen diseases, and pregnancy.&#xD;
  &#xD;
               10- Not taking inhaled or systemic steroids actively or within 3 months before the&#xD;
               procedure&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The patient's lack of consent to continue the study&#xD;
  &#xD;
            2. Failure to visit the patient for follow-up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alireza Peyman, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Isfahan ophthalmology research centre</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Isfahan eyes research centre</name>
        <address>
          <city>Isfahan</city>
          <zip>0098</zip>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Isfahan Eye Research Center</name>
        <address>
          <city>Isfahan</city>
          <zip>81746-73461</zip>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
      <investigator_full_name>Alireza Peyman</investigator_full_name>
      <investigator_title>Dr. Alireza Peyman</investigator_title>
    </responsible_party>
    <keyword>PRK</keyword>
    <keyword>MEDROXY PROGESTRONE</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Medroxyprogesterone Acetate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Will be shared upon request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05973253
  org study id: IR.MUI.MED.REC.1402.114
  nct id: NCT05973253
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  In this clinical trial, it is decided that 30 patients who are candidates for photorefractive
        keratectomy will receive a drop of prepared medroxyprogesterone randomly in one of their
        eyes, in addition to the routine antibiotic drop that is normally placed at the end of the
        procedure. Afterward, a bandage contact lens will be applied to both eyes, and the patients
        will receive routine post-procedure drops, including betamethasone and ciprofloxacin drops
        for both eyes. On the first, second, third, fourth, and fifth days after the operation, the
        patients will be examined, and the size of the epithelial defect in both eyes will be
        assessed using a slit lamp device. Additionally, the patients' pain levels in each eye will
        be evaluated using a questionnaire."
  
        The main question is: General purpose:
  
        Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the
        corneal epithelium after photorefractive keratectomy (PRK)
  Patients who have referred for refractive surgery to correct myopia and myopia-stigmatism
        first undergo complete examinations that are required before the procedure, which includes
        the following examinations:
  
          1. manifest and cycloplegic refraction
  
          2. UCVA and BCVA
  
          3. Pentacam(topographic imaging)
  
          4. Examining the anterior and posterior segments of the eye with a slit lamp device Placed.
             Then, on the day of the surgery, in the refractive surgery operating room, the eyes are
             prepared . Anesthetizing drops of enstocaine are poured into the eyes. After removing
             the corneal epithelium, laser ablation is performed using the Technolas Teneo 317
             device, and then mitomycin C is placed on the cornea based on the amount of ablation and
             then washed. At the end of the procedure, a contact lens bandage is placed on the eyes,
             and then a drop of the antibiotic ciprofloxacin is poured into the eyes. At this stage,
             a 1% medroxyprogesterone drop will be randomly poured into one of the eyes. After
             discharge, ciprofloxacin and betamethasone drops are routinely prescribed for the
             patient every 4 hours, and the patient returns for examination on the day after the
             operation and on the third and fifth days after the operation. (7) In each visit, the
             size of the corneal epithelial defect is measured by an ophthalmologist with a slit lamp
             examination as the largest length of the defect and the largest perpendicular length in
             millimeters. (2) Regarding the patient's pain and discomfort, a questionnaire is used to
             score the pain intensity by the patient (0: no pain, 1: mild pain, 2: moderate pain, 3:
             severe pain, 4: unbearable pain). (8) and the checklist includes information: pain
             intensity, optical size Defect, gender, age, ablation rate, and refractive error will be
             checked and recorded.
  
        The patient and the examiner do not know about the eye in which medroxyprogesterone drops
        were used at the end of the procedure.
  
        Medroxyprogesterone drops are made by a pharmacologist under sterile conditions and delivered
        the day before the operation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the corneal epithelium after photorefractive keratectomy (PRK)
  time frame: 3 months
  description: Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the corneal epithelium after photorefractive keratectomy (PRK)
  arm group label: eyes that recieved medroxy progestrone at the end of surgery
  arm group type: Experimental
  description: eyes that received one drop of medroxy progesterone at the end of the photorefractive keratectomy(PRK)
  arm group label: eyes did not recieved moderxy progestrone
  arm group type: No Intervention
  description: eyes that did not receive drop medroxy progesterone at the end of photorefractive keratectomy(PRK)
  intervention type: Drug
  intervention name: prepared drop of medroxy progestrone acetat 1%
  description: In 37 patients who are candidates for photorefractive keratectomy, at the end of the procedure, in one eye randomly, in addition to the antibiotic drop that is routinely placed at the end of the procedure, a drop of prepared medroxyprogesterone is also placed. Then, a bandage contact lens is placed on the eyes, and the patient receives the routine post-procedure drops that include betamethasone and ciprofloxacin drops for both eyes.
  arm group label: eyes that recieved medroxy progestrone at the end of surgery
  other name: depo provera
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alireza Peyman, MD
  role: Study Chair
  affiliation: Isfahan ophthalmology research centre
  facility: 
  facility: 
  country: Iran, Islamic Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Isfahan University of Medical Sciences
  investigator full name: Alireza Peyman
  investigator title: Dr. Alireza Peyman
  mesh term: Medroxyprogesterone Acetate
  sharing ipd: No
  ipd description: Will be shared upon request