<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/NCT02968290</url>
  </required_header>
  <id_info>
    <org_study_id>University od São Paulo</org_study_id>
    <nct_id>NCT02968290</nct_id>
  </id_info>
  <brief_title>Quantification of Posterior Capsule Opacification in Pediatric Cataract</brief_title>
  <acronym>Cataract</acronym>
  <official_title>Quantification of Posterior Capsule Opacity With Software Analysis Comparing Intraocular Lenses Hydrophilic x Hydrophobic in Pediatric Cataracts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to quantify the opacity of posterior capsule in pediatric&#xD;
      cataract comparing two intraocular lens materials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The eye exam at the first appointment will consist of anamnesis, external motor, evaluating&#xD;
      strabismus and nystagmus, visual acuity with and without correction, biomicroscopy,&#xD;
      fundoscopy, binocular ultrasound biometry, pachymetry and specular microscopy. The surgery&#xD;
      will be performed by a single surgeon under general anesthesia. All participants will receive&#xD;
      primary intraocular lens implantation as the randomization process, or hydrophobic acrylic&#xD;
      material or hydrophilic acrylic. The implanted intraocular lens differ primarily in the&#xD;
      material. The lens of hydrophobic acrylic materials (AcrySof SA60AT, Alcon Lab) single,&#xD;
      folding part, material acrylate / methacrylate with UV protection AcrySof filter, optical&#xD;
      diameter of 6.0 mm, total length of 13.0 mm, haptic angle of 0 degree with 360 degree double&#xD;
      square edge, spherical convex earlier. The lens hydrophilic acrylic material (Akreos ADAPT,&#xD;
      Bausch and Lomb) single, folding piece with optical diameter 6.00 mm and length de10.7 mm&#xD;
      aspheric convex in anterior and posterior with absorbent UV, haptic angle 0 degree angulation&#xD;
      . It has 4 attachment points (haptics) with 360 degree square double edge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2016</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">May 30, 2017</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opacification of posterior capsule measured by graduation through the software EPCO software</measure>
    <time_frame>360 days after cataract surgery</time_frame>
    <description>Photodocumentation with camera coupled to slit lamp adapter with external coaxial illumination of a fiber optic cable to the camera. After, analysis of opacification of the posterior capsule through the Evaluation of Posterior Capsule opacification software (EPCO 2000). The EPCO (Evaluation of Posterior Capsule Opacification) software is commercially available and offers some free access. The individual PCO score is calculated by multiplying the density of the opacification by the fraction of capsule area involved behind the IOL optic. It graded the PCO as 0 (none), 1 (minimal), 2 (mild), 3 (moderate) or 4 (severe). EPCO is one of the most used software for this purpose.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Posterior Capsule Opacification</condition>
  <arm_group>
    <arm_group_label>Hydrofobic material-Alcon AcrySof SA60AT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrofobic material.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrophilic material-Bausch Lomb AkreosA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrophilic material.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cataract Surgery</intervention_name>
    <description>Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device)</description>
    <arm_group_label>Hydrofobic material-Alcon AcrySof SA60AT</arm_group_label>
    <arm_group_label>Hydrophilic material-Bausch Lomb AkreosA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alcon AcrySof SA60AT</intervention_name>
    <description>Implant of intraocular lens hydrophobic</description>
    <arm_group_label>Hydrofobic material-Alcon AcrySof SA60AT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bausch Lomb AkreosA</intervention_name>
    <description>Implant of intraocular lens hydrophilic</description>
    <arm_group_label>Hydrophilic material-Bausch Lomb AkreosA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  indication for cataract surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  traumatic cataract&#xD;
&#xD;
          -  neurological diseases that do not allow the exams&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Humberto Castro Lima</name>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <zip>41830630</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.</citation>
    <PMID>15640920</PMID>
  </results_reference>
  <results_reference>
    <citation>Gasper C, Trivedi RH, Wilson ME. Complications of Pediatric Cataract Surgery. Dev Ophthalmol. 2016;57:69-84. doi: 10.1159/000442502. Epub 2016 Apr 1.</citation>
    <PMID>27043393</PMID>
  </results_reference>
  <results_reference>
    <citation>Panahi-Bazaz MR, Zamani M, Abazar B. Hydrophilic Acrylic versus PMMA Intraocular Lens Implantation in Pediatric Cataract Surgery. J Ophthalmic Vis Res. 2009 Oct;4(4):201-7.</citation>
    <PMID>23198075</PMID>
  </results_reference>
  <results_reference>
    <citation>Lin H, Yang Y, Chen J, Zhong X, Liu Z, Lin Z, Chen W, Luo L, Qu B, Zhang X, Zheng D, Zhan J, Wu H, Wang Z, Geng Y, Xiang W, Chen W, Liu Y; CCPMOH Study Group. Congenital cataract: prevalence and surgery age at Zhongshan Ophthalmic Center (ZOC). PLoS One. 2014 Jul 3;9(7):e101781. doi: 10.1371/journal.pone.0101781. eCollection 2014.</citation>
    <PMID>24992190</PMID>
  </results_reference>
  <results_reference>
    <citation>Werner L, Tetz M, Feldmann I, Bucker M. Evaluating and defining the sharpness of intraocular lenses: microedge structure of commercially available square-edged hydrophilic intraocular lenses. J Cataract Refract Surg. 2009 Mar;35(3):556-66. doi: 10.1016/j.jcrs.2008.11.042.</citation>
    <PMID>19251151</PMID>
  </results_reference>
  <results_reference>
    <citation>Kleinmann G, Zaugg B, Apple DJ, Bleik J. Pediatric cataract surgery with hydrophilic acrylic intraocular lens. J AAPOS. 2013 Aug;17(4):367-70. doi: 10.1016/j.jaapos.2013.04.007. Epub 2013 Aug 6.</citation>
    <PMID>23928003</PMID>
  </results_reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>camila ribeiro koch pena</investigator_full_name>
    <investigator_title>Professor of medical residency of ophthalmology and PhD student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Capsule Opacification</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02968290
org study id: University od São Paulo
nct id: NCT02968290
lead sponsor: 
has dmc: Yes
The purpose of this study is to quantify the opacity of posterior capsule in pediatric
      cataract comparing two intraocular lens materials.
The eye exam at the first appointment will consist of anamnesis, external motor, evaluating
      strabismus and nystagmus, visual acuity with and without correction, biomicroscopy,
      fundoscopy, binocular ultrasound biometry, pachymetry and specular microscopy. The surgery
      will be performed by a single surgeon under general anesthesia. All participants will receive
      primary intraocular lens implantation as the randomization process, or hydrophobic acrylic
      material or hydrophilic acrylic. The implanted intraocular lens differ primarily in the
      material. The lens of hydrophobic acrylic materials (AcrySof SA60AT, Alcon Lab) single,
      folding part, material acrylate / methacrylate with UV protection AcrySof filter, optical
      diameter of 6.0 mm, total length of 13.0 mm, haptic angle of 0 degree with 360 degree double
      square edge, spherical convex earlier. The lens hydrophilic acrylic material (Akreos ADAPT,
      Bausch and Lomb) single, folding piece with optical diameter 6.00 mm and length de10.7 mm
      aspheric convex in anterior and posterior with absorbent UV, haptic angle 0 degree angulation
      . It has 4 attachment points (haptics) with 360 degree square double edge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Opacification of posterior capsule measured by graduation through the software EPCO software
time frame: 360 days after cataract surgery
description: Photodocumentation with camera coupled to slit lamp adapter with external coaxial illumination of a fiber optic cable to the camera. After, analysis of opacification of the posterior capsule through the Evaluation of Posterior Capsule opacification software (EPCO 2000). The EPCO (Evaluation of Posterior Capsule Opacification) software is commercially available and offers some free access. The individual PCO score is calculated by multiplying the density of the opacification by the fraction of capsule area involved behind the IOL optic. It graded the PCO as 0 (none), 1 (minimal), 2 (mild), 3 (moderate) or 4 (severe). EPCO is one of the most used software for this purpose.
arm group label: Hydrofobic material-Alcon AcrySof SA60AT
arm group type: Active Comparator
description: Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrofobic material.
arm group label: Hydrophilic material-Bausch Lomb AkreosA
arm group type: Active Comparator
description: Intervention- Cataract Surgery with implantation of intraocular lens. In this arm will be implantation hydrophilic material.
intervention type: Procedure
intervention name: Cataract Surgery
description: Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device)
arm group label: Hydrofobic material-Alcon AcrySof SA60AT
arm group label: Hydrophilic material-Bausch Lomb AkreosA
intervention type: Device
intervention name: Alcon AcrySof SA60AT
description: Implant of intraocular lens hydrophobic
arm group label: Hydrofobic material-Alcon AcrySof SA60AT
intervention type: Device
intervention name: Bausch Lomb AkreosA
description: Implant of intraocular lens hydrophilic
arm group label: Hydrophilic material-Bausch Lomb AkreosA
criteria: 
gender: All
minimum age: 5 Years
maximum age: 12 Years
healthy volunteers: No
facility: 
country: Brazil
citation: Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.
PMID: 15640920
citation: Gasper C, Trivedi RH, Wilson ME. Complications of Pediatric Cataract Surgery. Dev Ophthalmol. 2016;57:69-84. doi: 10.1159/000442502. Epub 2016 Apr 1.
PMID: 27043393
citation: Panahi-Bazaz MR, Zamani M, Abazar B. Hydrophilic Acrylic versus PMMA Intraocular Lens Implantation in Pediatric Cataract Surgery. J Ophthalmic Vis Res. 2009 Oct;4(4):201-7.
PMID: 23198075
citation: Lin H, Yang Y, Chen J, Zhong X, Liu Z, Lin Z, Chen W, Luo L, Qu B, Zhang X, Zheng D, Zhan J, Wu H, Wang Z, Geng Y, Xiang W, Chen W, Liu Y; CCPMOH Study Group. Congenital cataract: prevalence and surgery age at Zhongshan Ophthalmic Center (ZOC). PLoS One. 2014 Jul 3;9(7):e101781. doi: 10.1371/journal.pone.0101781. eCollection 2014.
PMID: 24992190
citation: Werner L, Tetz M, Feldmann I, Bucker M. Evaluating and defining the sharpness of intraocular lenses: microedge structure of commercially available square-edged hydrophilic intraocular lenses. J Cataract Refract Surg. 2009 Mar;35(3):556-66. doi: 10.1016/j.jcrs.2008.11.042.
PMID: 19251151
citation: Kleinmann G, Zaugg B, Apple DJ, Bleik J. Pediatric cataract surgery with hydrophilic acrylic intraocular lens. J AAPOS. 2013 Aug;17(4):367-70. doi: 10.1016/j.jaapos.2013.04.007. Epub 2013 Aug 6.
PMID: 23928003
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: camila ribeiro koch pena
investigator title: Professor of medical residency of ophthalmology and PhD student
mesh term: Cataract
mesh term: Capsule Opacification
sharing ipd: Undecided