<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/NCT03266354</url>
  </required_header>
  <id_info>
    <org_study_id>CECCAPIOL</org_study_id>
    <nct_id>NCT03266354</nct_id>
  </id_info>
  <brief_title>Changes of the Corneal Endothelial Cell Count After Artisan Phakic Intraocular Lens Implantation</brief_title>
  <official_title>Changes of the Corneal Endothelial Cell Count After Artisan Phakic Intraocular Lens Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      the investigator will evaluate the change in endothelial cell count in eyes implanted with&#xD;
      the iris-claw phakic Artisan lens for treatment of moderate to high myopia using specular&#xD;
      microscopy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Iris-fixated phakic intraocular lenses (pIOLs) are used worldwide to correct high myopia,&#xD;
      hyperopia, and astigmatism. It is used to correct high degrees of myopia in patients for whom&#xD;
      laser excimer refractive surgery is not indicated.&#xD;
&#xD;
      The Artisan lens is designed to minimize the contact between the iris and the IOL resulting&#xD;
      in less halo and glare from the prism effect.&#xD;
&#xD;
      Several clinical studies show that the visual results of the Artisan lens are stable and&#xD;
      predictable. Artisan phakic IOLs provides precise predictability.&#xD;
&#xD;
      There have been concerns that the anterior chamber lens could damage the endothelial cell&#xD;
      layer because of its proximity to the cornea. The manufacturer advises using the Artisan lens&#xD;
      only in eyes with an ECD greater than 2000 cells/mm2 and an ACD greater than 2.6 mm.&#xD;
&#xD;
      Corneal endothelium is metabolically active and responsible for keeping the corneal stroma in&#xD;
      its usual dehydrated state of 70% water.&#xD;
&#xD;
      loss of endothelial cells from increasing age, trauma, disease, or corneal surgery can reduce&#xD;
      the density of endothelial cells and affect the ability of the endothelium to maintain it's&#xD;
      primary function.&#xD;
&#xD;
      Alterations in the corneal endothelium depend on surgical technique and style; although&#xD;
      endothelial cell loss is mainly the result of surgical trauma, continuous endothelial cell&#xD;
      loss can occur. Late corneal decompensation often occurs in the absence of direct&#xD;
      intraoperative endothelial trauma. These complications can be explained by the toxic effect&#xD;
      of inflammatory mediators on the corneal endothelium.&#xD;
&#xD;
      Specular microscopy is used to view and record non-invasively the image of the corneal&#xD;
      endothelial cell layer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the Corneal endothelial cell count after Artisan phakic intraocular lens implantation</measure>
    <time_frame>5 minutes</time_frame>
    <description>specular microscopy will be performed on a number of myopic patients before and after implantation of the rigid Artisan iris-fixated pIOL to analyze the change in corneal endothelial cell count.</description>
  </primary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>High Myopia</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>specular microscopy before and after Artisan PIOL</intervention_name>
    <description>specular microscopy will be performed before and after implantation of the rigid Artisan iris-fixated pIOL to analyze the change in corneal endothelial cell count</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with Artisan PIOL&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  an age greater than 20 years, stable myopia with a variation in spherical equivalent&#xD;
             of less than -0.50 diopter (D) during the 12 month preoperative period, a normal&#xD;
             anterior segment with an ACD (i.e., the area between the corneal endothelium and the&#xD;
             central anterior lens capsule) greater than 3.00 mm, an endothelial cell count of 2000&#xD;
             cells/mm2 or greater, no corneal, pupil, or iris abnormalities; and no history of&#xD;
             glaucoma and chronic or recurrent uveitis , having contraindications to laser in situ&#xD;
             keratomileusis based on pachymetric data or other corneal shape characteristics, and&#xD;
             an intraocular pressure of 20 mm Hg or less.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  an ACD less than 3.0 mm, history of ocular surgery, glaucoma, chronic uveitis, or&#xD;
             preexisting ocular pathologic features or abnormalities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>gamal rashed, professor</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fculty of medicine, Assiut university</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Menezo JL, Peris-Martinez C, Cisneros AL, Martinez-Costa R. Phakic intraocular lenses to correct high myopia: Adatomed, Staar, and Artisan. J Cataract Refract Surg. 2004 Jan;30(1):33-44. doi: 10.1016/j.jcrs.2003.11.023.</citation>
    <PMID>14967266</PMID>
  </reference>
  <reference>
    <citation>Menezo JL, Avino JA, Cisneros A, Rodriguez-Salvador V, Martinez-Costa R. Iris claw phakic intraocular lens for high myopia. J Refract Surg. 1997 Sep-Oct;13(6):545-55. doi: 10.3928/1081-597X-19970901-11.</citation>
    <PMID>9352483</PMID>
  </reference>
  <reference>
    <citation>Menezo JL, Cisneros AL, Rodriguez-Salvador V. Endothelial study of iris-claw phakic lens: four year follow-up. J Cataract Refract Surg. 1998 Aug;24(8):1039-49. doi: 10.1016/s0886-3350(98)80096-5.</citation>
    <PMID>9719962</PMID>
  </reference>
  <reference>
    <citation>Benedetti S, Casamenti V, Benedetti M. Long-term endothelial changes in phakic eyes after Artisan intraocular lens implantation to correct myopia: five-year study. J Cataract Refract Surg. 2007 May;33(5):784-90. doi: 10.1016/j.jcrs.2007.01.037.</citation>
    <PMID>17466848</PMID>
  </reference>
  <reference>
    <citation>STOCKER FW. The endothelium of the cornea and its clinical implications. Trans Am Ophthalmol Soc. 1953;51:669-786. No abstract available.</citation>
    <PMID>13216798</PMID>
  </reference>
  <reference>
    <citation>Mishima S. Clinical investigations on the corneal endothelium. Ophthalmology. 1982 Jun;89(6):525-30. doi: 10.1016/s0161-6420(82)34755-7.</citation>
    <PMID>6750487</PMID>
  </reference>
  <reference>
    <citation>Waring GO 3rd, Bourne WM, Edelhauser HF, Kenyon KR. The corneal endothelium. Normal and pathologic structure and function. Ophthalmology. 1982 Jun;89(6):531-90.</citation>
    <PMID>7122038</PMID>
  </reference>
  <reference>
    <citation>Joyce NC. Cell cycle status in human corneal endothelium. Exp Eye Res. 2005 Dec;81(6):629-38. doi: 10.1016/j.exer.2005.06.012. Epub 2005 Jul 28.</citation>
    <PMID>16054624</PMID>
  </reference>
  <reference>
    <citation>Maurice DM. Cellular membrane activity in the corneal endothelium of the intact eye. Experientia. 1968 Nov 15;24(11):1094-5. doi: 10.1007/BF02147776. No abstract available.</citation>
    <PMID>5721120</PMID>
  </reference>
  <reference>
    <citation>Laing RA, Sandstrom MM, Leibowitz HM. In vivo photomicrography of the corneal endothelium. Arch Ophthalmol. 1975 Feb;93(2):143-5. doi: 10.1001/archopht.1975.01010020149013.</citation>
    <PMID>1115675</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Omar</investigator_full_name>
    <investigator_title>resident</investigator_title>
  </responsible_party>
  <keyword>Artisan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</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/NCT03266354
org study id: CECCAPIOL
nct id: NCT03266354
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
the investigator will evaluate the change in endothelial cell count in eyes implanted with
      the iris-claw phakic Artisan lens for treatment of moderate to high myopia using specular
      microscopy
Iris-fixated phakic intraocular lenses (pIOLs) are used worldwide to correct high myopia,
      hyperopia, and astigmatism. It is used to correct high degrees of myopia in patients for whom
      laser excimer refractive surgery is not indicated.

      The Artisan lens is designed to minimize the contact between the iris and the IOL resulting
      in less halo and glare from the prism effect.

      Several clinical studies show that the visual results of the Artisan lens are stable and
      predictable. Artisan phakic IOLs provides precise predictability.

      There have been concerns that the anterior chamber lens could damage the endothelial cell
      layer because of its proximity to the cornea. The manufacturer advises using the Artisan lens
      only in eyes with an ECD greater than 2000 cells/mm2 and an ACD greater than 2.6 mm.

      Corneal endothelium is metabolically active and responsible for keeping the corneal stroma in
      its usual dehydrated state of 70% water.

      loss of endothelial cells from increasing age, trauma, disease, or corneal surgery can reduce
      the density of endothelial cells and affect the ability of the endothelium to maintain it's
      primary function.

      Alterations in the corneal endothelium depend on surgical technique and style; although
      endothelial cell loss is mainly the result of surgical trauma, continuous endothelial cell
      loss can occur. Late corneal decompensation often occurs in the absence of direct
      intraoperative endothelial trauma. These complications can be explained by the toxic effect
      of inflammatory mediators on the corneal endothelium.

      Specular microscopy is used to view and record non-invasively the image of the corneal
      endothelial cell layer.
observational model: Case-Only
time perspective: Prospective
measure: Changes in the Corneal endothelial cell count after Artisan phakic intraocular lens implantation
time frame: 5 minutes
description: specular microscopy will be performed on a number of myopic patients before and after implantation of the rigid Artisan iris-fixated pIOL to analyze the change in corneal endothelial cell count.
intervention type: Procedure
intervention name: specular microscopy before and after Artisan PIOL
description: specular microscopy will be performed before and after implantation of the rigid Artisan iris-fixated pIOL to analyze the change in corneal endothelial cell count
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: gamal rashed, professor
role: Study Chair
affiliation: Assiut University
facility: 
country: Egypt
citation: Menezo JL, Peris-Martinez C, Cisneros AL, Martinez-Costa R. Phakic intraocular lenses to correct high myopia: Adatomed, Staar, and Artisan. J Cataract Refract Surg. 2004 Jan;30(1):33-44. doi: 10.1016/j.jcrs.2003.11.023.
PMID: 14967266
citation: Menezo JL, Avino JA, Cisneros A, Rodriguez-Salvador V, Martinez-Costa R. Iris claw phakic intraocular lens for high myopia. J Refract Surg. 1997 Sep-Oct;13(6):545-55. doi: 10.3928/1081-597X-19970901-11.
PMID: 9352483
citation: Menezo JL, Cisneros AL, Rodriguez-Salvador V. Endothelial study of iris-claw phakic lens: four year follow-up. J Cataract Refract Surg. 1998 Aug;24(8):1039-49. doi: 10.1016/s0886-3350(98)80096-5.
PMID: 9719962
citation: Benedetti S, Casamenti V, Benedetti M. Long-term endothelial changes in phakic eyes after Artisan intraocular lens implantation to correct myopia: five-year study. J Cataract Refract Surg. 2007 May;33(5):784-90. doi: 10.1016/j.jcrs.2007.01.037.
PMID: 17466848
citation: STOCKER FW. The endothelium of the cornea and its clinical implications. Trans Am Ophthalmol Soc. 1953;51:669-786. No abstract available.
PMID: 13216798
citation: Mishima S. Clinical investigations on the corneal endothelium. Ophthalmology. 1982 Jun;89(6):525-30. doi: 10.1016/s0161-6420(82)34755-7.
PMID: 6750487
citation: Waring GO 3rd, Bourne WM, Edelhauser HF, Kenyon KR. The corneal endothelium. Normal and pathologic structure and function. Ophthalmology. 1982 Jun;89(6):531-90.
PMID: 7122038
citation: Joyce NC. Cell cycle status in human corneal endothelium. Exp Eye Res. 2005 Dec;81(6):629-38. doi: 10.1016/j.exer.2005.06.012. Epub 2005 Jul 28.
PMID: 16054624
citation: Maurice DM. Cellular membrane activity in the corneal endothelium of the intact eye. Experientia. 1968 Nov 15;24(11):1094-5. doi: 10.1007/BF02147776. No abstract available.
PMID: 5721120
citation: Laing RA, Sandstrom MM, Leibowitz HM. In vivo photomicrography of the corneal endothelium. Arch Ophthalmol. 1975 Feb;93(2):143-5. doi: 10.1001/archopht.1975.01010020149013.
PMID: 1115675
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Omar
investigator title: resident
mesh term: Myopia