<?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>IRCT201103116032N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-06-01</date_registration>
      <primary_sponsor>Ahwaz Jondishapour University Of Medicine Science</primary_sponsor>
      <public_title>The evaluation of aphakic iris claw intraocular lens implantation results</public_title>
      <acronym></acronym>
      <scientific_title>Outcomes of primary iris claw intraocular lens implantation for correction aphakia in comparison with scleral fixation intraocular lens implantation during pars plana deep vitrectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6495</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Aphakia.</hc_freetext>
      <i_freetext>The ARTISAN aphakia IOL is a polymethyl methacrylate IOL with an 8.5-mm length, and a 5.5-mm optical zone. In one group patients, initialy a standard 3-port Pars Plana vitrectomy were performed. Crystalline lens or fragment of nucleus that dropped into vitreous extracted by phacofragmentation. Dislocated IOL in vitreous extracted from limbal incision. Then acetylcholine 1% was injected to constrict the pupil and from limbal incision an Artisan IOL was inserted in&#13;
the anterior chamber. The iris was hooked between the claw-like footplates to achieve perfect IOL centration over the pupil. Finally, the incision was closed with 10–0 nylon sutures. Control group patients were selected retrospectively, from patients that undergo pars plana vitrectomy and sclera fixation Posterior Chamber IOL implantation in past..</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Afkari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadegan.S</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 1222 8076</telephone>
        <email>abafkari@yahoo.com</email>
        <affiliation>Imam Khomeini Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Feraidoon Farrahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadegan .S</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673166</zip>
        <telephone>+98 61 1222 8076</telephone>
        <email>feraidoonfarrahi@yahoo.com</email>
        <affiliation>Ahwaz Jondishapour University Of Medicine Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Dislocation of total crystalline lens v/s fragment of nucleus v/s IOL in vitreous after complicated cataract surgery or due to trauma, Absence of capsular support for IOL implantation in capsular bag or ciliary sulcus&#13;
Exclusion criteria: Uncontrolled glaucoma, recurrent uveitis history, severe iris damage, proliferative diabetic retinopathy, macular scar</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The ARTISAN aphakia IOL is a polymethyl methacrylate IOL with an 8.5-mm length, and a 5.5-mm optical zone. In one group patients, initialy a standard 3-port Pars Plana vitrectomy were performed. Crystalline lens or fragment of nucleus that dropped into vitreous extracted by phacofragmentation. Dislocated IOL in vitreous extracted from limbal incision. Then acetylcholine 1% was injected to constrict the pupil and from limbal incision an Artisan IOL was inserted in&#13;
the anterior chamber. The iris was hooked between the claw-like footplates to achieve perfect IOL centration over the pupil. Finally, the incision was closed with 10–0 nylon sutures. Control group patients were selected retrospectively, from patients that undergo pars plana vitrectomy and sclera fixation Posterior Chamber IOL implantation in past.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Uncorrected visual acuity (UCVA). Timepoint: one day preoperatively and the first day, third day, at the end of the first. Method of measurement: visual acuity without correction based on snellen chart at 6 meter.</prim_outcome>
      <prim_outcome>Best corrected visual acuity (BCVA). Timepoint: one day preoperatively and the first day, third day, at the end of the first. Method of measurement: visual acuity based on snellen chart at 6 meter,after correction.(based on subjective refraction.</prim_outcome>
      <prim_outcome>Central corneal thickness (CCT). Timepoint: one day preoperatively and the first day, third day, at the end of the first. Method of measurement: central corneal thickness (micron) based on Pachymetry.</prim_outcome>
      <prim_outcome>Spherical equivalent (SE). Timepoint: one day preoperatively and the first day, third day, at the end of the first. Method of measurement: spherical power (diopter) based on objective refraction.:    S.E  =Sphere+Cylinder/2.</prim_outcome>
      <prim_outcome>Astigmatism. Timepoint: one day preoperatively and the first day, third day, at the end of the first. Method of measurement: cylinder power based on objective refraction.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cystoid macular edema (complication). Timepoint: one day preoperatively and the first day, third day, at the end of the first. Method of measurement: Edema in macular zone based on fundus examination.(confirmed by OCT).</sec_outcome>
      <sec_outcome>Intra ocular pressure(IOP) increase (complication). Timepoint: one day preoperatively and the first day, third day, at the end of the first. Method of measurement: IOP&gt; 22 mmHg (Based on Goldmann Tonometer).</sec_outcome>
      <sec_outcome>Retinal Detachment (complication). Timepoint: one day preoperatively and the first day, third day, at the end of the first. Method of measurement: Based on fundus examination.</sec_outcome>
      <sec_outcome>Lens haptic displacement (complication). Timepoint: one day preoperatively and the first day, third day, at the end of the first. Method of measurement: Based on Slit Lamp examination.</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>Ahwaz Jondishapour University Of Medicine Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-07-15</approval_date>
        <contact_name>Ahwaz Jondishapour University Of Medicine Science</contact_name>
        <contact_address>Golestan street, Aahvaz Ahwaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
