<?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>IRCT20240404061413N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-01</date_registration>
      <primary_sponsor>Alshifa trust eye hospital</primary_sponsor>
      <public_title>[comparing two treatments in resolving a retinal/eye disorder] Per oral Eplerenone and topical nepafenac are being compared in the treatment of central serous chorioretinopathy.</public_title>
      <acronym></acronym>
      <scientific_title>Oral mineralocorticoid-receptor antagonist vs 0.3 % nepafenac for the treatment of acute central serous chorioretinopathy: a prospective, randomized comparative study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76276</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned (1:1) to either the 50 mg eplerenone (Epler- Platinum Pharmaceuticals) or 0.3 % nepafenac (Ilevro–Novartis) group by a trial statistician through a password-protected system online. Allocation was stratified by best corrected visual acuity and hospital(s). 
All participants, care teams, outcome assessors, pharmacists, and members of the trial management group were masked to the treatment allocation, Blinding description: Prescribing surgeon/doctor, optometrist assessing visual acuity, pharmacists (enclosed coded box of same dimensions), retinal scan technician were masked to the treatment allocation. 
The person assessing the primary and secondary outcomes would not be aware what treatment has been given to the patients.
Oral eplerenone is taken per oral whereas nepafenac is being given topically. Both are effective treatments in acute central serous chorioretinopathy. 
Both interventions have different routes of administration. Eplerenone is a tablet whereas nepafenac a drop formulation.
The main study team are blind to the participants chosen treatment. the trial statistician who wasn't involved in data collection has information on allocated treatment for the ethics committee and monitoring.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Acute central serous retinopathy in a eye retinal disorder which involves by serous retinal detachment (SRD) due to one or more leakage areas from the choroid through a defect in the retinal pigment epithelium (RPE), and a dome shaped serous pigment epithelial detachment (PEDs)..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:1. Oral eplerenone 50 mg in two divided doses (25 mg tablet twice day)12 hours apart for 6 weeks will be given. Medicine taken after meals at the same time each day. Epler (platinum pharma, Pakistan). Intervention 2: Intervention group: 2. Topical nepafenac 0.3 % will be given. one drop in the morning in the affected eye in the lower cul de sac. Patient will be advised to keep the eye closed for 30 seconds. Nevanac 0.3 % eye drops by Alcon/Novartis Group USA.</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 privileged info (by hospital)</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad hasan alizai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>jhelum road</address>
        <city>rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>42000</zip>
        <telephone>+92 321 5180996</telephone>
        <email>alizai111@gmail.com</email>
        <affiliation>Alshifa trust eye hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad hasan alizai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>jhelum road</address>
        <city>rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>42000</zip>
        <telephone>+92 321 5180996</telephone>
        <email>alizai111@gmail.com</email>
        <affiliation>Alshifa trust eye hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>acute central serous chorioretinopathy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>chronic central serous chorioretinopathy
contraindications to oral eplerenone or topical nepafenac
retinal or choroidal pathologies
severe ocular disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H35.71</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Central serous chorioretinopathy</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>Intervention group:1. Oral eplerenone 50 mg in two divided doses (25 mg tablet twice day)12 hours apart for 6 weeks will be given. Medicine taken after meals at the same time each day. Epler (platinum pharma, Pakistan)</i_keyword>
      <i_keyword>Intervention group: 2. Topical nepafenac 0.3 % will be given. one drop in the morning in the affected eye in the lower cul de sac. Patient will be advised to keep the eye closed for 30 seconds. Nevanac 0.3 % eye drops by Alcon/Novartis Group USA.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary outcome measures were best corrected visual acuity comparisons between the treatment group (oral eplerenone &amp; topical nepafenac) in the study eye at every visit. Timepoint: Before intervention and 6, 12 and 24 weeks after either intervention. Method of measurement: optometrist/technician will measure the vision with a Snellen chart as letters read with prescription glasses , if any.</prim_outcome>
      <prim_outcome>Primary outcome measures were subretinal fluid height measurements between the treatment group (oral eplerenone &amp; topical nepafenac) in the study eye at every visit. Timepoint: Before intervention and 6, 12 and 24 weeks after either intervention. Method of measurement: optical coherence tomography.</prim_outcome>
      <prim_outcome>Primary outcome measures were sub-foveal choroidal thickness measurements between the treatment group (oral eplerenone &amp; topical nepafenac) in the study eye at every visit. Timepoint: Before intervention and 6, 12 and 24 weeks after either intervention. Method of measurement: optical coherence tomography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Secondary outcome was serum potassium level evaluation in oral eplerenone group. Timepoint: Before intervention and 6 weeks. Method of measurement: Serum potassium levels will be measured with a lab kit at six weeks to assess any derangements.</sec_outcome>
      <sec_outcome>Secondary outcome were topical nepafenac drug tolerance evaluated at each visit. Timepoint: Before intervention and 6, 12 , 24 weeks after either intervention. Method of measurement: Slit lamp examination will be done to determine any possible side effects related to topical nepafenac  (primarily corneal and conjunctival side effects).</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>Alshifa trust eye hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-01</approval_date>
        <contact_name>Al-Shifa trust eye hospital</contact_name>
        <contact_address>jhelum road rawalpindi Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
