<?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>IRCT2016081329326N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-11</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Latanaprost eye drop on retina after cataract surgery in glaucoma patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of continuation of prostaglandin analogue use on the incidence of Cystoid Macular Edema (CME) following uncomplicated cataract surgery in glaucoma patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>166</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23602</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: A computer-based program (Excel® Microsoft Office software version 2016) to assign our samples to the two groups was used. The randomization used was block permutated randomization with the random block size of 2,4 and 6. The random sequence obtained by a biostatistician and it was concealed from the research group by coloring the background of cells in Excel datasheet. Whenever each new patient was a candidate for allocation, one author (M.M) uncolored the devoted cell and allocated the patient according to the written number, 1 for continuing and 2 for stop continuing latanoprost, Blinding description: The design of the RCT was single-masked. Patients were aware of the allocation, while surgeon/examiner (GH.F.), outcome assessor/analyst (M.Y.) were masked to the patient allocation which was done by M.M.</study_design>
      <phase>2</phase>
      <hc_freetext>Cystoid macular edema.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group : In this group, prostaglandin analogue (Latanaprost eye drop) is discontinued immediately after cataract surgery for 3 months and replaced with other antiglaucoma agents to control IOP. Intervention 2: Control group: Prostaglandin analogue (Latanaprost eye drop, one drop before sleep at night) after cataract surgery will be continued.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>https://www.jcrsjournal.org/article/S0886-3350(19)30428-6/abstract</results_url_link>
      <results_summary>Purpose
To evaluate the effect of postoperative latanoprost administration on central macular thickness (CMT) after uneventful cataract surgery in glaucoma patients.

Setting
Farabi Eye Hospital, Tehran, Iran.

Design
Prospective randomized clinical trial.

Methods
In this single-masked trial, glaucoma patients treated with latanoprost who had no other risk factor for the development of pseudophakic macular edema were randomly allocated to continuation of latanoprost or discontinuation of the drop after uneventful cataract surgery. At baseline and postoperatively at 1 month and 3 months, patients had complete ocular examinations and CMT measurements using optical coherence tomography. The main outcome measure was the change in the CMT between baseline measurements and postoperative measurements at 1 month and 3 months.

Results
One hundred fifty-six eyes (latanoprost 76; discontinuation 80) finished the trial. There were no differences in baseline patient demographics or characteristics, including the CMT, between the two groups. There was transient increase in the mean CMT by 12 μm ± 49 (SD) in the latanoprost group at 1 month (P = .03); however, the value returned to baseline by 3 months (6 ± 55 μm; P = .27). The between-group difference in the mean change in the CMT from baseline was −3.1 μm (95% confidence interval [CI], −18.4 to 12.0; P = .68) after 1 month and −10.5 μm (95% CI, −26.6 to 5.5; P = .19) after 3 months; the differences were not significant.

Conclusion
Latanoprost administration after cataract surgery had no measurable effect on macular thickness.</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 Not published due to Farabi Eye Research department guidelines.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Masoud Mirghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farabi Eye Hospital, Qazvin sq, South Kargar st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1336616351</zip>
        <telephone>+98 21 5540 0003</telephone>
        <email>m-mirghorbani@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghasem Fakhraie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farabi Eye Hospital, Qazvin sq, South Kargar st</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1336616351</zip>
        <telephone>+98 21 5540 0003</telephone>
        <email>fakhraie@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Glaucoma patients with 18 years old or more
Treating with topical latanoprost 0.005% eye drop at least for 6 months with or without other antiglaucoma topical agents
Who needed cataract surgery (phacoemulsification)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of any intraocular surgery, intravitreal injections, or retinal laser
History of trauma
Non-glaucomatous optic neuropathy
High myopia
History of diabetic retinopathy, any age-related macular degeneration (AMD), uveitis, retinal detachment (RD), epiretinal membrane (ERM), and retinal vascular disorders
An occurrence of CME in the fellow eye following previous cataract surgery
Recent history of NSAID therapy (topical or oral)
Any abnormality in fundus examination except for glaucomatous changes
Any abnormality in pre-operative macular OCT.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H35.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified retinal disorders</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 : In this group, prostaglandin analogue (Latanaprost eye drop) is discontinued immediately after cataract surgery for 3 months and replaced with other antiglaucoma agents to control IOP.</i_keyword>
      <i_keyword>Control group: Prostaglandin analogue (Latanaprost eye drop, one drop before sleep at night) after cataract surgery will be continued.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Central Macular Thickness. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Using OCT-SD imaging.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Intraocular pressure. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Goldmann tonometry.</sec_outcome>
      <sec_outcome>Visual acuity. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Snellen chart.</sec_outcome>
      <sec_outcome>Number of medications needed to control the IOP. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Medical records.</sec_outcome>
      <sec_outcome>Incidence of clinical cystoid macular edema. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Clinical Fundus examination.</sec_outcome>
      <sec_outcome>Incidence of significant increase in CMT. Timepoint: Before intervention, 1 month after intervention and 3 months after intervention. Method of measurement: Defined as ≥ 50 µm compared to the baseline in OCT imaging.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-06</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Farabi Eye Hospital, Qazvin sq, South Kargar st Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
