<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/NCT03304366</url>
  </required_header>
  <id_info>
    <org_study_id>Pentacam</org_study_id>
    <nct_id>NCT03304366</nct_id>
  </id_info>
  <brief_title>Corneal Changes With Pentacam Before and After Pterygium</brief_title>
  <official_title>The Use of Pentacam in Assessment of Corneal Changes After Pterygium Excision</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>
      Aim of this study is to assess the corneal changes before and after pterygium excision by&#xD;
      using pentacam system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pterygium is a dysplasia of the bulbar conjunctiva extending onto the corneal surface. The&#xD;
      prevelance of pterygium ranges from 0.7% to 31% in various populations according to the&#xD;
      location, altitude, and race. It has a higher prevelance in areas which have increased&#xD;
      exposure to direct sun with ultraviolet (UV) B light. Patients with pterygia present with&#xD;
      variety of complaints ,ranging from asymptomatic to significant redness ,swelling ,itching&#xD;
      ,irritation and blurring of vision associated with elevated lesions of the conjunctiva and&#xD;
      contiguous cornea in one or both eyes.The induction of astigmatism due to the invasion of the&#xD;
      pterygium into the cornea as well as changes in corneal curvature and refractive status has&#xD;
      been reported by numerous studies.&#xD;
&#xD;
      Multiple different procedures have been advocated in the treatment of pterygia. These&#xD;
      procedures range from simple excision to sliding flaps of conjunctiva with or without&#xD;
      adjunctive external beta radiation therapy and/or use of topical chemotherapeutic agents,&#xD;
      such as Mitomycin C.&#xD;
&#xD;
      Pentacam is a rotating Scheimpflug camera which measures Scheimpflug images of the anterior&#xD;
      eye segment. With the pentacam, topographic analysis of the corneal front and back surfaces&#xD;
      is based on the true elevation measurement from one side of the cornea to the other (limbus&#xD;
      to limbus). Pentacam also describes the true thickness of the cornea across its entire&#xD;
      breadth and width.&#xD;
&#xD;
      Type of the study: prospective observational longitudinal study&#xD;
&#xD;
      Study Setting: Assuit University Hospital ( ophthalmology Department ) Assuit Police Hospital&#xD;
      ( ophthalmology Department )&#xD;
&#xD;
      Study subjects:&#xD;
&#xD;
        1. Inclusion criteria:&#xD;
&#xD;
             -  The study will include 30 eyes of adult subjects.&#xD;
&#xD;
             -  All eyes have primary pterygium and seeking for surgery due to Cosmetic problems,&#xD;
                ocular irritation, and, or visual impairment.&#xD;
&#xD;
             -  All selected patients will undergo complete ophthalmological examination including&#xD;
                refraction, best corrected visual acuity, keratometry, and pentacam (scheimpflug&#xD;
                imaging) preoperatively then will be followed up 2 and 6 months post pterygium&#xD;
                excision.&#xD;
&#xD;
        2. Exclusion criteria:&#xD;
&#xD;
             -  patients with recurrent pterygium.&#xD;
&#xD;
             -  Patients with media opacities:&#xD;
&#xD;
                  -  Dense cataract. - Corneal opacities.&#xD;
&#xD;
             -  Patients with a history of intraocular surgery ,ocular trauma ,and contact lens&#xD;
                wear.&#xD;
&#xD;
             -  Patients with severe ocular surface disorders as Stevens-Johnson syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pentacam analysis.</measure>
    <time_frame>preoperative and then will be followed up 2 and 6 months post pterygium excision.</time_frame>
    <description>Corneal changes such as thickness and elevations</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pterygium</condition>
  <arm_group>
    <arm_group_label>Patients with primary pterygium</arm_group_label>
    <description>All eyes have primary pterygium and seeking for surgery due to Cosmetic problems, ocular irritation, and, or visual impairment.&#xD;
All selected patients will undergo complete ophthalmological examination including refraction, best corrected visual acuity, keratometry, and pentacam (scheimpflug imaging) preoperatively then will be followed up 2 and 6 months post pterygium excision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pentacam (scheimpflug imaging)</intervention_name>
    <description>Corneal changes including thickness, elevations....etc</description>
    <arm_group_label>Patients with primary pterygium</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with primary pterygium comes to Assiut University Hospital, Assiut Police&#xD;
        Hospital, Private clinic They will perform the Pentacam analysis at Assuit Eye research&#xD;
        centers (Alforsan-Elnoor)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All eyes have primary pterygium and seeking for surgery due to Cosmetic problems,&#xD;
             ocular irritation, and, or visual impairment.&#xD;
&#xD;
          -  All selected patients will undergo complete ophthalmological examination including&#xD;
             refraction, best corrected visual acuity, keratometry, and pentacam (scheimpflug&#xD;
             imaging) preoperatively then will be followed up 2 and 6 months post pterygium&#xD;
             excision.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with recurrent pterygium.&#xD;
&#xD;
          -  Patients with media opacities: Dense cataract, Corneal opacities.&#xD;
&#xD;
          -  Patients with a history of intraocular surgery ,ocular trauma ,and contact lens wear.&#xD;
&#xD;
          -  Patients with severe ocular surface disorders as Stevens-Johnson syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammed S Abdelrahman, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammed G Abdelsalam, MBBCH</last_name>
    <phone>01111188664</phone>
    <phone_ext>002</phone_ext>
    <email>drmoh_gamal85@yahoo.com</email>
  </overall_contact>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Gamal</investigator_full_name>
    <investigator_title>Resident Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pterygium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Sharing the results for other researchers</ipd_description>
  </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/NCT03304366
org study id: Pentacam
nct id: NCT03304366
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of this study is to assess the corneal changes before and after pterygium excision by
      using pentacam system.
Pterygium is a dysplasia of the bulbar conjunctiva extending onto the corneal surface. The
      prevelance of pterygium ranges from 0.7% to 31% in various populations according to the
      location, altitude, and race. It has a higher prevelance in areas which have increased
      exposure to direct sun with ultraviolet (UV) B light. Patients with pterygia present with
      variety of complaints ,ranging from asymptomatic to significant redness ,swelling ,itching
      ,irritation and blurring of vision associated with elevated lesions of the conjunctiva and
      contiguous cornea in one or both eyes.The induction of astigmatism due to the invasion of the
      pterygium into the cornea as well as changes in corneal curvature and refractive status has
      been reported by numerous studies.

      Multiple different procedures have been advocated in the treatment of pterygia. These
      procedures range from simple excision to sliding flaps of conjunctiva with or without
      adjunctive external beta radiation therapy and/or use of topical chemotherapeutic agents,
      such as Mitomycin C.

      Pentacam is a rotating Scheimpflug camera which measures Scheimpflug images of the anterior
      eye segment. With the pentacam, topographic analysis of the corneal front and back surfaces
      is based on the true elevation measurement from one side of the cornea to the other (limbus
      to limbus). Pentacam also describes the true thickness of the cornea across its entire
      breadth and width.

      Type of the study: prospective observational longitudinal study

      Study Setting: Assuit University Hospital ( ophthalmology Department ) Assuit Police Hospital
      ( ophthalmology Department )

      Study subjects:

        1. Inclusion criteria:

             -  The study will include 30 eyes of adult subjects.

             -  All eyes have primary pterygium and seeking for surgery due to Cosmetic problems,
                ocular irritation, and, or visual impairment.

             -  All selected patients will undergo complete ophthalmological examination including
                refraction, best corrected visual acuity, keratometry, and pentacam (scheimpflug
                imaging) preoperatively then will be followed up 2 and 6 months post pterygium
                excision.

        2. Exclusion criteria:

             -  patients with recurrent pterygium.

             -  Patients with media opacities:

                  -  Dense cataract. - Corneal opacities.

             -  Patients with a history of intraocular surgery ,ocular trauma ,and contact lens
                wear.

             -  Patients with severe ocular surface disorders as Stevens-Johnson syndrome.
observational model: Cohort
time perspective: Prospective
measure: Pentacam analysis.
time frame: preoperative and then will be followed up 2 and 6 months post pterygium excision.
description: Corneal changes such as thickness and elevations
arm group label: Patients with primary pterygium
description: All eyes have primary pterygium and seeking for surgery due to Cosmetic problems, ocular irritation, and, or visual impairment.
All selected patients will undergo complete ophthalmological examination including refraction, best corrected visual acuity, keratometry, and pentacam (scheimpflug imaging) preoperatively then will be followed up 2 and 6 months post pterygium excision.
intervention type: Diagnostic Test
intervention name: Pentacam (scheimpflug imaging)
description: Corneal changes including thickness, elevations....etc
arm group label: Patients with primary pterygium
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mohammed S Abdelrahman, Prof
role: Study Chair
affiliation: Assiut University
last name: Mohammed G Abdelsalam, MBBCH
phone: 01111188664
phone ext: 002
email: drmoh_gamal85@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Gamal
investigator title: Resident Physician
mesh term: Pterygium
sharing ipd: Undecided
ipd description: Sharing the results for other researchers