<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/NCT03262285</url>
  </required_header>
  <id_info>
    <org_study_id>CECLPEECCE</org_study_id>
    <nct_id>NCT03262285</nct_id>
  </id_info>
  <brief_title>Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction</brief_title>
  <official_title>Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction in Management of Senile Cataract</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      the investigators will compare between the endothelial cell loss after phacoemulsification&#xD;
      and extracapsular cataract extraction in management of senile cataract&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Age related cataract is believed to be the main cause of reversible blindness worldwide and&#xD;
      in developing countries. Population-based studies have reported that cataract is responsible&#xD;
      for 47.8% to 51% of all global blindness.&#xD;
&#xD;
      Several studies compared phacoemulsification and conventional extracapsular cataract&#xD;
      extraction regarding several aspects such as postoperative inflammation and visual&#xD;
      rehabilitation. studies proved that phacoemulsification has faster rehabilitation ,less&#xD;
      astigmatism and better postoperative vision .However, Extracapsular cataract extraction is&#xD;
      still the operation of choice in some cataract cases.&#xD;
&#xD;
      The normal corneal endothelium is a single layer of uniformly sized cells with a&#xD;
      predominantly hexagonal shape. Adult density of approximately 2400 - 3200 cells/mm².The&#xD;
      number of cells decreases at about 0.6% per year and neighbouring cells enlarge to fill the&#xD;
      space as the cells cannot regenerate.The minimum cell density necessary for adequate function&#xD;
      is in the range of 400 to 700 cells/mm2.&#xD;
&#xD;
      The effect of cataract surgery on corneal endothelium is an important factor that affects&#xD;
      postoperative vision .However, it is accepted all over the world that there is definite loss&#xD;
      of some endothelial cells with all techniques of cataract surgery. Previously, cataract&#xD;
      surgery caused enormous loss of endothelial cells , but with enhancement of equipment and&#xD;
      surgical techniques, cataract surgery today results in 6-14%loss of endothelial cells.&#xD;
&#xD;
      Specular microscopy is a noninvasive photographic technique that allows visualization and&#xD;
      analysis of corneal endothelium. specular microscopy is used to show cell count and cell&#xD;
      shape in the scanned area.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</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>percentage of endothelial cell loss</measure>
    <time_frame>5 minutes</time_frame>
    <description>specular microscopy will be done to measure the endothelial cell count before and after the intervention to measure the percentage of loss</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in shape of endothelial cell</measure>
    <time_frame>5 minutes</time_frame>
    <description>specular microscopy will be done to identify changes in hexagonality of endothelial cells after the intervention</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Senile Cataract</condition>
  <arm_group>
    <arm_group_label>phacoemulsification</arm_group_label>
    <description>patients undergoing phacoemulsification surgery for senile cataract</description>
  </arm_group>
  <arm_group>
    <arm_group_label>extracapsular cataract extraction</arm_group_label>
    <description>patients undergoing extracapsular cataract extraction surgery for senile cataract</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>phacoemulsification</intervention_name>
    <description>removal of cataract using ultrasound waves</description>
    <arm_group_label>phacoemulsification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>extracapsular cataract extraction</intervention_name>
    <description>removal of cataract using surgical corneal incision</description>
    <arm_group_label>extracapsular cataract extraction</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with senile cataract&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cases of senile cataract of both sexes will be included in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Corneal endothelial pathologies such as Fuch's dystrophy&#xD;
&#xD;
          -  Complicated cataract&#xD;
&#xD;
          -  Cataract with history of trauma&#xD;
&#xD;
          -  Coexisting eye pathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ali Ryad, professor</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Lundstrom M, Goh PP, Henry Y, Salowi MA, Barry P, Manning S, Rosen P, Stenevi U. The changing pattern of cataract surgery indications: a 5-year study of 2 cataract surgery databases. Ophthalmology. 2015 Jan;122(1):31-8. doi: 10.1016/j.ophtha.2014.07.047. Epub 2014 Sep 16.</citation>
    <PMID>25234011</PMID>
  </reference>
  <reference>
    <citation>Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11.</citation>
    <PMID>25104599</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Wang W, Yan W, Muller A, He M. A Global View on Output and Outcomes of Cataract Surgery With National Indices of Socioeconomic Development. Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3669-3676. doi: 10.1167/iovs.17-21489.</citation>
    <PMID>28728174</PMID>
  </reference>
  <reference>
    <citation>Gogate PM, Kulkarni SR, Krishnaiah S, Deshpande RD, Joshi SA, Palimkar A, Deshpande MD. Safety and efficacy of phacoemulsification compared with manual small-incision cataract surgery by a randomized controlled clinical trial: six-week results. Ophthalmology. 2005 May;112(5):869-74. doi: 10.1016/j.ophtha.2004.11.055.</citation>
    <PMID>15878068</PMID>
  </reference>
  <reference>
    <citation>Bourne WM, Nelson LR, Hodge DO. Central corneal endothelial cell changes over a ten-year period. Invest Ophthalmol Vis Sci. 1997 Mar;38(3):779-82.</citation>
    <PMID>9071233</PMID>
  </reference>
  <reference>
    <citation>Bourne RR, Minassian DC, Dart JK, Rosen P, Kaushal S, Wingate N. Effect of cataract surgery on the corneal endothelium: modern phacoemulsification compared with extracapsular cataract surgery. Ophthalmology. 2004 Apr;111(4):679-85. doi: 10.1016/j.ophtha.2003.07.015.</citation>
    <PMID>15051198</PMID>
  </reference>
  <reference>
    <citation>Trnavec B, Cuvala J, Cernak A, Vodrazkova E. [Comparison of corneal endothelial cells after ECCE and phacoemulsification of the lens]. Cesk Slov Oftalmol. 1997 Aug;53(4):240-3. Slovak.</citation>
    <PMID>9377317</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Rawda Abdelnaser</investigator_full_name>
    <investigator_title>resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Corneal Endothelial Cell Loss</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/NCT03262285
org study id: CECLPEECCE
nct id: NCT03262285
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the investigators will compare between the endothelial cell loss after phacoemulsification
      and extracapsular cataract extraction in management of senile cataract
Age related cataract is believed to be the main cause of reversible blindness worldwide and
      in developing countries. Population-based studies have reported that cataract is responsible
      for 47.8% to 51% of all global blindness.

      Several studies compared phacoemulsification and conventional extracapsular cataract
      extraction regarding several aspects such as postoperative inflammation and visual
      rehabilitation. studies proved that phacoemulsification has faster rehabilitation ,less
      astigmatism and better postoperative vision .However, Extracapsular cataract extraction is
      still the operation of choice in some cataract cases.

      The normal corneal endothelium is a single layer of uniformly sized cells with a
      predominantly hexagonal shape. Adult density of approximately 2400 - 3200 cells/mm².The
      number of cells decreases at about 0.6% per year and neighbouring cells enlarge to fill the
      space as the cells cannot regenerate.The minimum cell density necessary for adequate function
      is in the range of 400 to 700 cells/mm2.

      The effect of cataract surgery on corneal endothelium is an important factor that affects
      postoperative vision .However, it is accepted all over the world that there is definite loss
      of some endothelial cells with all techniques of cataract surgery. Previously, cataract
      surgery caused enormous loss of endothelial cells , but with enhancement of equipment and
      surgical techniques, cataract surgery today results in 6-14%loss of endothelial cells.

      Specular microscopy is a noninvasive photographic technique that allows visualization and
      analysis of corneal endothelium. specular microscopy is used to show cell count and cell
      shape in the scanned area.
observational model: Case-Only
time perspective: Prospective
measure: percentage of endothelial cell loss
time frame: 5 minutes
description: specular microscopy will be done to measure the endothelial cell count before and after the intervention to measure the percentage of loss
measure: changes in shape of endothelial cell
time frame: 5 minutes
description: specular microscopy will be done to identify changes in hexagonality of endothelial cells after the intervention
arm group label: phacoemulsification
description: patients undergoing phacoemulsification surgery for senile cataract
arm group label: extracapsular cataract extraction
description: patients undergoing extracapsular cataract extraction surgery for senile cataract
intervention type: Procedure
intervention name: phacoemulsification
description: removal of cataract using ultrasound waves
arm group label: phacoemulsification
intervention type: Procedure
intervention name: extracapsular cataract extraction
description: removal of cataract using surgical corneal incision
arm group label: extracapsular cataract extraction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ali Ryad, professor
role: Study Chair
affiliation: Assiut University
facility: 
country: Egypt
citation: Lundstrom M, Goh PP, Henry Y, Salowi MA, Barry P, Manning S, Rosen P, Stenevi U. The changing pattern of cataract surgery indications: a 5-year study of 2 cataract surgery databases. Ophthalmology. 2015 Jan;122(1):31-8. doi: 10.1016/j.ophtha.2014.07.047. Epub 2014 Sep 16.
PMID: 25234011
citation: Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11.
PMID: 25104599
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: Wang W, Yan W, Muller A, He M. A Global View on Output and Outcomes of Cataract Surgery With National Indices of Socioeconomic Development. Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3669-3676. doi: 10.1167/iovs.17-21489.
PMID: 28728174
citation: Gogate PM, Kulkarni SR, Krishnaiah S, Deshpande RD, Joshi SA, Palimkar A, Deshpande MD. Safety and efficacy of phacoemulsification compared with manual small-incision cataract surgery by a randomized controlled clinical trial: six-week results. Ophthalmology. 2005 May;112(5):869-74. doi: 10.1016/j.ophtha.2004.11.055.
PMID: 15878068
citation: Bourne WM, Nelson LR, Hodge DO. Central corneal endothelial cell changes over a ten-year period. Invest Ophthalmol Vis Sci. 1997 Mar;38(3):779-82.
PMID: 9071233
citation: Bourne RR, Minassian DC, Dart JK, Rosen P, Kaushal S, Wingate N. Effect of cataract surgery on the corneal endothelium: modern phacoemulsification compared with extracapsular cataract surgery. Ophthalmology. 2004 Apr;111(4):679-85. doi: 10.1016/j.ophtha.2003.07.015.
PMID: 15051198
citation: Trnavec B, Cuvala J, Cernak A, Vodrazkova E. [Comparison of corneal endothelial cells after ECCE and phacoemulsification of the lens]. Cesk Slov Oftalmol. 1997 Aug;53(4):240-3. Slovak.
PMID: 9377317
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Rawda Abdelnaser
investigator title: resident
mesh term: Cataract
mesh term: Corneal Endothelial Cell Loss