<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/NCT01718184</url>
  </required_header>
  <id_info>
    <org_study_id>RabinMC Sulcoflex Toric IOL</org_study_id>
    <nct_id>NCT01718184</nct_id>
  </id_info>
  <brief_title>Piggyback Sulcoflex Toric IOL for Correcting Refractive Error Following Corneal Transplantation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Einat Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective study to evaluate the safety and efficacy of a piggyback sulcoflex toric&#xD;
      intraocular lens in pseudophakic patients for correcting refractive errors following corneal&#xD;
      transplantation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Best corrected and uncorrected visual acuity</measure>
    <time_frame>3 month</time_frame>
    <description>Best corrected and uncorrected visual acuity following the IOL implantation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular complications</measure>
    <time_frame>3 months</time_frame>
    <description>pigmentary dispersion, iris bulging, inter lenticular opacifications, lens decentration</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Refractive outcomes</measure>
    <time_frame>3 months</time_frame>
    <description>refractive outcomes following surgical intervention</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Refractive Error</condition>
  <condition>Corneal Implantation</condition>
  <condition>Intraocular Lens Implantation</condition>
  <arm_group>
    <arm_group_label>Sulcoflex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sulcoflex intraocular lens implantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>toric intraocular lens implantation</intervention_name>
    <description>piggyback Sulcolflex toric intraocular lens implantation</description>
    <arm_group_label>Sulcoflex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sulcoflex intraocular lens implantation</intervention_name>
    <arm_group_label>Sulcoflex</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  after corneal transplantation with refractive errors&#xD;
&#xD;
          -  after cataract removal and intraocular lens implantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other ophthalmologic disorders limiting vision including glaucoma, AMD, profound&#xD;
             amblyopia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irit Bahar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rabim Medical Center, Israel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Irit Bahar, MD</last_name>
    <phone>972-3-9376101</phone>
    <email>iritbahar@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alon Zahavi, MD</last_name>
    <phone>972-3-9376101</phone>
    <email>alonzahavi@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah Tiqwa</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Irit Bahar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Leaming DV. Practice styles and preferences of ASCRS members--2003 survey. J Cataract Refract Surg. 2004 Apr;30(4):892-900. doi: 10.1016/j.jcrs.2004.02.064.</citation>
    <PMID>15093657</PMID>
  </reference>
  <reference>
    <citation>Mamalis N, Brubaker J, Davis D, Espandar L, Werner L. Complications of foldable intraocular lenses requiring explantation or secondary intervention--2007 survey update. J Cataract Refract Surg. 2008 Sep;34(9):1584-91. doi: 10.1016/j.jcrs.2008.05.046.</citation>
    <PMID>18721724</PMID>
  </reference>
  <reference>
    <citation>Paul RA, Chew HF, Singal N, Rootman DS, Slomovic AR. Piggyback intraocular lens implantation to correct myopic pseudophakic refractive error after penetrating keratoplasty. J Cataract Refract Surg. 2004 Apr;30(4):821-5. doi: 10.1016/j.jcrs.2003.08.008.</citation>
    <PMID>15093644</PMID>
  </reference>
  <reference>
    <citation>Gayton JL, Sanders VN. Implanting two posterior chamber intraocular lenses in a case of microphthalmos. J Cataract Refract Surg. 1993 Nov;19(6):776-7. doi: 10.1016/s0886-3350(13)80349-5.</citation>
    <PMID>8271176</PMID>
  </reference>
  <reference>
    <citation>Gayton JL. Secondary implantation of a double intraocular lens after penetrating keratoplasty. J Cataract Refract Surg. 1998 Feb;24(2):281-2. doi: 10.1016/s0886-3350(98)80212-5.</citation>
    <PMID>9530606</PMID>
  </reference>
  <reference>
    <citation>Gayton JL, Sanders V, Van der Karr M, Raanan MG. Piggybacking intraocular implants to correct pseudophakic refractive error. Ophthalmology. 1999 Jan;106(1):56-9. doi: 10.1016/S0161-6420(99)90005-2.</citation>
    <PMID>9917781</PMID>
  </reference>
  <reference>
    <citation>Habot-Wilner Z, Sachs D, Cahane M, Alhalel A, Desatnik H, Schwalb E, Barequet IS. Refractive results with secondary piggyback implantation to correct pseudophakic refractive errors. J Cataract Refract Surg. 2005 Nov;31(11):2101-3. doi: 10.1016/j.jcrs.2005.05.023.</citation>
    <PMID>16412922</PMID>
  </reference>
  <reference>
    <citation>Werner L, Shugar JK, Apple DJ, Pandey SK, Escobar-Gomez M, Visessook N, Evans BB. Opacification of piggyback IOLs associated with an amorphous material attached to interlenticular surfaces. J Cataract Refract Surg. 2000 Nov;26(11):1612-9. doi: 10.1016/s0886-3350(00)00485-5.</citation>
    <PMID>11084268</PMID>
  </reference>
  <reference>
    <citation>Werner L, Apple DJ, Pandey SK, Solomon KD, Snyder ME, Brint SF, Gayton JL, Shugar JK, Trivedi RH, Izak AM. Analysis of elements of interlenticular opacification. Am J Ophthalmol. 2002 Mar;133(3):320-6. doi: 10.1016/s0002-9394(01)01405-2.</citation>
    <PMID>11860967</PMID>
  </reference>
  <reference>
    <citation>Baumeister M, Kohnen T. Scheimpflug measurement of intraocular lens position after piggyback implantation of foldable intraocular lenses in eyes with high hyperopia. J Cataract Refract Surg. 2006 Dec;32(12):2098-104. doi: 10.1016/j.jcrs.2006.08.033.</citation>
    <PMID>17137990</PMID>
  </reference>
  <reference>
    <citation>Chang SH, Lim G. Secondary pigmentary glaucoma associated with piggyback intraocular lens implantation. J Cataract Refract Surg. 2004 Oct;30(10):2219-22. doi: 10.1016/j.jcrs.2004.03.034.</citation>
    <PMID>15474839</PMID>
  </reference>
  <reference>
    <citation>Chang WH, Werner L, Fry LL, Johnson JT, Kamae K, Mamalis N. Pigmentary dispersion syndrome with a secondary piggyback 3-piece hydrophobic acrylic lens. Case report with clinicopathological correlation. J Cataract Refract Surg. 2007 Jun;33(6):1106-9. doi: 10.1016/j.jcrs.2007.01.044.</citation>
    <PMID>17531710</PMID>
  </reference>
  <reference>
    <citation>Iwase T, Tanaka N. Elevated intraocular pressure in secondary piggyback intraocular lens implantation. J Cataract Refract Surg. 2005 Sep;31(9):1821-3. doi: 10.1016/j.jcrs.2005.06.034.</citation>
    <PMID>16246790</PMID>
  </reference>
  <reference>
    <citation>Durak I, Ferliel ST, Soylev M, Saatci O. Pre-Descemet's membrane hemorrhage after secondary intraocular lens implantation. J Cataract Refract Surg. 1999 Nov;25(11):1554-6. doi: 10.1016/s0886-3350(99)00249-7.</citation>
    <PMID>10569176</PMID>
  </reference>
  <reference>
    <citation>Kahraman G, Amon M. New supplementary intraocular lens for refractive enhancement in pseudophakic patients. J Cataract Refract Surg. 2010 Jul;36(7):1090-4. doi: 10.1016/j.jcrs.2009.12.045.</citation>
    <PMID>20610084</PMID>
  </reference>
  <reference>
    <citation>Khan MI, Muhtaseb M. Performance of the Sulcoflex piggyback intraocular lens in pseudophakic patients. J Refract Surg. 2011 Sep;27(9):693-6. doi: 10.3928/1081597X-20110512-01. Epub 2011 May 20.</citation>
    <PMID>21598871</PMID>
  </reference>
  <reference>
    <citation>McIntyre JS, Werner L, Fuller SR, Kavoussi SC, Hill M, Mamalis N. Assessment of a single-piece hydrophilic acrylic IOL for piggyback sulcus fixation in pseudophakic cadaver eyes. J Cataract Refract Surg. 2012 Jan;38(1):155-62. doi: 10.1016/j.jcrs.2011.06.035. Epub 2011 Nov 4.</citation>
    <PMID>22055074</PMID>
  </reference>
  <verification_date>July 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 29, 2012</last_update_submitted>
  <last_update_submitted_qc>October 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sulcoflex</keyword>
  <keyword>toric</keyword>
  <keyword>corneal implantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Refractive Errors</mesh_term>
  </condition_browse>
  <!-- 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/NCT01718184
org study id: RabinMC Sulcoflex Toric IOL
nct id: NCT01718184
lead sponsor: 
collaborator: 
has dmc: Yes
A prospective study to evaluate the safety and efficacy of a piggyback sulcoflex toric
      intraocular lens in pseudophakic patients for correcting refractive errors following corneal
      transplantation
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Best corrected and uncorrected visual acuity
time frame: 3 month
description: Best corrected and uncorrected visual acuity following the IOL implantation
measure: Ocular complications
time frame: 3 months
description: pigmentary dispersion, iris bulging, inter lenticular opacifications, lens decentration
measure: Refractive outcomes
time frame: 3 months
description: refractive outcomes following surgical intervention
arm group label: Sulcoflex
arm group type: Experimental
description: Sulcoflex intraocular lens implantation
intervention type: Procedure
intervention name: toric intraocular lens implantation
description: piggyback Sulcolflex toric intraocular lens implantation
arm group label: Sulcoflex
intervention type: Procedure
intervention name: Sulcoflex intraocular lens implantation
arm group label: Sulcoflex
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Irit Bahar, MD
role: Principal Investigator
affiliation: Rabim Medical Center, Israel
last name: Irit Bahar, MD
phone: 972-3-9376101
email: iritbahar@gmail.com
last name: Alon Zahavi, MD
phone: 972-3-9376101
email: alonzahavi@gmail.com
facility: 
status: Recruiting
investigator: 
country: Israel
citation: Leaming DV. Practice styles and preferences of ASCRS members--2003 survey. J Cataract Refract Surg. 2004 Apr;30(4):892-900. doi: 10.1016/j.jcrs.2004.02.064.
PMID: 15093657
citation: Mamalis N, Brubaker J, Davis D, Espandar L, Werner L. Complications of foldable intraocular lenses requiring explantation or secondary intervention--2007 survey update. J Cataract Refract Surg. 2008 Sep;34(9):1584-91. doi: 10.1016/j.jcrs.2008.05.046.
PMID: 18721724
citation: Paul RA, Chew HF, Singal N, Rootman DS, Slomovic AR. Piggyback intraocular lens implantation to correct myopic pseudophakic refractive error after penetrating keratoplasty. J Cataract Refract Surg. 2004 Apr;30(4):821-5. doi: 10.1016/j.jcrs.2003.08.008.
PMID: 15093644
citation: Gayton JL, Sanders VN. Implanting two posterior chamber intraocular lenses in a case of microphthalmos. J Cataract Refract Surg. 1993 Nov;19(6):776-7. doi: 10.1016/s0886-3350(13)80349-5.
PMID: 8271176
citation: Gayton JL. Secondary implantation of a double intraocular lens after penetrating keratoplasty. J Cataract Refract Surg. 1998 Feb;24(2):281-2. doi: 10.1016/s0886-3350(98)80212-5.
PMID: 9530606
citation: Gayton JL, Sanders V, Van der Karr M, Raanan MG. Piggybacking intraocular implants to correct pseudophakic refractive error. Ophthalmology. 1999 Jan;106(1):56-9. doi: 10.1016/S0161-6420(99)90005-2.
PMID: 9917781
citation: Habot-Wilner Z, Sachs D, Cahane M, Alhalel A, Desatnik H, Schwalb E, Barequet IS. Refractive results with secondary piggyback implantation to correct pseudophakic refractive errors. J Cataract Refract Surg. 2005 Nov;31(11):2101-3. doi: 10.1016/j.jcrs.2005.05.023.
PMID: 16412922
citation: Werner L, Shugar JK, Apple DJ, Pandey SK, Escobar-Gomez M, Visessook N, Evans BB. Opacification of piggyback IOLs associated with an amorphous material attached to interlenticular surfaces. J Cataract Refract Surg. 2000 Nov;26(11):1612-9. doi: 10.1016/s0886-3350(00)00485-5.
PMID: 11084268
citation: Werner L, Apple DJ, Pandey SK, Solomon KD, Snyder ME, Brint SF, Gayton JL, Shugar JK, Trivedi RH, Izak AM. Analysis of elements of interlenticular opacification. Am J Ophthalmol. 2002 Mar;133(3):320-6. doi: 10.1016/s0002-9394(01)01405-2.
PMID: 11860967
citation: Baumeister M, Kohnen T. Scheimpflug measurement of intraocular lens position after piggyback implantation of foldable intraocular lenses in eyes with high hyperopia. J Cataract Refract Surg. 2006 Dec;32(12):2098-104. doi: 10.1016/j.jcrs.2006.08.033.
PMID: 17137990
citation: Chang SH, Lim G. Secondary pigmentary glaucoma associated with piggyback intraocular lens implantation. J Cataract Refract Surg. 2004 Oct;30(10):2219-22. doi: 10.1016/j.jcrs.2004.03.034.
PMID: 15474839
citation: Chang WH, Werner L, Fry LL, Johnson JT, Kamae K, Mamalis N. Pigmentary dispersion syndrome with a secondary piggyback 3-piece hydrophobic acrylic lens. Case report with clinicopathological correlation. J Cataract Refract Surg. 2007 Jun;33(6):1106-9. doi: 10.1016/j.jcrs.2007.01.044.
PMID: 17531710
citation: Iwase T, Tanaka N. Elevated intraocular pressure in secondary piggyback intraocular lens implantation. J Cataract Refract Surg. 2005 Sep;31(9):1821-3. doi: 10.1016/j.jcrs.2005.06.034.
PMID: 16246790
citation: Durak I, Ferliel ST, Soylev M, Saatci O. Pre-Descemet's membrane hemorrhage after secondary intraocular lens implantation. J Cataract Refract Surg. 1999 Nov;25(11):1554-6. doi: 10.1016/s0886-3350(99)00249-7.
PMID: 10569176
citation: Kahraman G, Amon M. New supplementary intraocular lens for refractive enhancement in pseudophakic patients. J Cataract Refract Surg. 2010 Jul;36(7):1090-4. doi: 10.1016/j.jcrs.2009.12.045.
PMID: 20610084
citation: Khan MI, Muhtaseb M. Performance of the Sulcoflex piggyback intraocular lens in pseudophakic patients. J Refract Surg. 2011 Sep;27(9):693-6. doi: 10.3928/1081597X-20110512-01. Epub 2011 May 20.
PMID: 21598871
citation: McIntyre JS, Werner L, Fuller SR, Kavoussi SC, Hill M, Mamalis N. Assessment of a single-piece hydrophilic acrylic IOL for piggyback sulcus fixation in pseudophakic cadaver eyes. J Cataract Refract Surg. 2012 Jan;38(1):155-62. doi: 10.1016/j.jcrs.2011.06.035. Epub 2011 Nov 4.
PMID: 22055074
responsible party type: Sponsor
mesh term: Refractive Errors