<?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>IRCT20231031059914N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-13</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Coffee on Eye</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Caffeine on Choroidal Thickness, Vascularization index, and Anterior Segment Parameters of the Eye in healthy population</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73472</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Blinding description: In this study, the participants will be unaware of the presence or absence of caffeine in each phase of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Choroidal thickness changes. Condition 2: Changes in anterior segment factors. Condition 3: Changes in choroidal vascular index.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: These people are given caffeinated coffee. Intervention 2: Control group: These people are given decaffeinated coffee.</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:
The non-identified information of people will be accessible to people after the publication of the article.

When:
The access period starts 3 months after the publication of the article

To whom:
The public will be allowed to access the information.

Conditions:
For all scientific requests, documents can be used.

Where to obtain:
Contact the following Email:
I.Varshovi@Gmail.com

How to obtain:
The request will be sent to the individual within one month after being raised in the clinical trial scientific group.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Iman Varshovi-Jaghargh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 8, No. 13, Hashemieh 63</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9178175751</zip>
        <telephone>+98 51 3881 8761</telephone>
        <email>I.Varshovi@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Asieh Ehsaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 7, No. 23, Mina 6, Mina Ave., Bahar 18, Sajjad Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9174324401</zip>
        <telephone>+98 51 3884 6719</telephone>
        <email>Ehsaeia@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ocular health in normal examination
Not using hard contact lenses in the last month
Not using soft contact lenses in the last two weeks
Personal consent to participate in the research project
Not consuming coffee at least 4 hours before attending the program
No smoking
Not drinking coffee or any caffeinated drinks during the test</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of systemic and ophthalmic disease
People with cardiac arrhythmia
History of hypertension, diabetes, glaucoma, uveitis
Pregnancy and breastfeeding
Taking medications that affect posterior and anterior segment of the eye
History of eye surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: These people are given caffeinated coffee.</i_keyword>
      <i_keyword>Control group: These people are given decaffeinated coffee.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Choroidal vascularity index. Timepoint: Before intervention and 1, 2, 3, and 4 hours after intervention. Method of measurement: Posterior and anterior optical coherence tomography.</prim_outcome>
      <prim_outcome>Angle-opening distance. Timepoint: Before intervention and 1, 2, 3, and 4 hours after intervention. Method of measurement: Posterior and anterior optical coherence tomography.</prim_outcome>
      <prim_outcome>Trabecular iris angle. Timepoint: Before intervention and 1, 2, 3, and 4 hours after intervention. Method of measurement: Posterior and anterior optical coherence tomography.</prim_outcome>
      <prim_outcome>Trabecular iris space area. Timepoint: Before intervention and 1, 2, 3, and 4 hours after intervention. Method of measurement: Posterior and anterior optical coherence tomography.</prim_outcome>
      <prim_outcome>Anterior chamber depth. Timepoint: Before intervention and 1, 2, 3, and 4 hours after intervention. Method of measurement: Posterior and anterior optical coherence tomography.</prim_outcome>
      <prim_outcome>Choroidal thickness. Timepoint: Before intervention and 1, 2, 3, and 4 hours after intervention. Method of measurement: Posterior and anterior optical coherence tomography.</prim_outcome>
      <prim_outcome>Corneal thickness. Timepoint: Before intervention and 1, 2, 3, and 4 hours after intervention. Method of measurement: Posterior and anterior optical coherence tomography.</prim_outcome>
      <prim_outcome>Choroidal luminal thickness. Timepoint: Before intervention and 1, 2, 3, and 4 hours after intervention. Method of measurement: Posterior and anterior optical coherence tomography.</prim_outcome>
      <prim_outcome>Choroidal stromal thickness. Timepoint: Before intervention and 1, 2, 3, and 4 hours after intervention. Method of measurement: Posterior and anterior optical coherence tomography.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-07</approval_date>
        <contact_name>Research Ethics Committees of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Qureishi Building, Daneshgah Street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
