<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/NCT03291873</url>
  </required_header>
  <id_info>
    <org_study_id>900800700600500400300200100900</org_study_id>
    <nct_id>NCT03291873</nct_id>
  </id_info>
  <brief_title>Topography-Guided Customized PRK Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism</brief_title>
  <official_title>Topography-Guided Customized PRK (Photorefractive Keratectomy) Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</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>
      This study will include patients who will undergo PRK in both eyes, for each patient each eye&#xD;
      will be randomly allocated to one of 2 procedures:&#xD;
&#xD;
      topography-guided ablation in one eye (group I) and Q-factor customized ablation in the other&#xD;
      eye (group II).&#xD;
&#xD;
      Alcon/Wavelight Light Laser Technolo¬gie (GmbH, Erlangen, Germany) will be used for&#xD;
      photoablation.&#xD;
&#xD;
      The wavelight Topolyzer (Wavelight AG, Erlan¬gen, Germany)and CSO Sirius scheimpflug camera&#xD;
      combined with Placido corneal topography (CSO, Florence,Italy) will be used before and 1, 3&#xD;
      and 6 months after PRK. Refrac¬tive visual outcomes and corneal aberration changes will be&#xD;
      compared between the two treatment modalities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2017</start_date>
  <completion_date type="Actual">June 25, 2019</completion_date>
  <primary_completion_date type="Actual">June 25, 2019</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in Postoperative spherical equivalent depending on manifest refraction after autorefractometer</measure>
    <time_frame>1 , 3 and 6 months postoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change in visual acuity using snellen chart</measure>
    <time_frame>1 , 3 and 6 months postoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change in corneal wavefront aberrations</measure>
    <time_frame>1 , 3 and 6 months postoperative</time_frame>
    <description>assessed by topolyzer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in Q value anterior at 6mm RMS, RMS of astigmatism, RMS of coma and RMS of spherical aberrations. Strehl ratio : Qvalue,RMS,strehl ratio by CSO Sirius scheimpflug</measure>
    <time_frame>1,3 and 6months</time_frame>
    <description>by CSO Sirius scheimpflug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in total RMS</measure>
    <time_frame>1,3 and 6months</time_frame>
    <description>by CSO Sirius scheimpflug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in strehl ratio</measure>
    <time_frame>1,3 and 6 months</time_frame>
    <description>by CSO scheimpflug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in Q value</measure>
    <time_frame>1,3 and 6 months</time_frame>
    <description>assessed by topolyzer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>efficacy:ratio of postoperative decimal UDVA to preoperative decimal CDVA</measure>
    <time_frame>6 months</time_frame>
    <description>ratio of postoperative decimal UDVA to preoperative decimal CDVA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>contrast sensitivity</measure>
    <time_frame>6 months</time_frame>
    <description>cambridge low contrast sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>predictability</measure>
    <time_frame>6 months</time_frame>
    <description>eyes within 1.0 D of emmetropia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety:ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA</measure>
    <time_frame>6 months</time_frame>
    <description>ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stability</measure>
    <time_frame>6 months</time_frame>
    <description>change of more than 0.5D over</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>topography guided PRK in one eye</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topography-guided (placido disk- based) using T-CAT Contoura treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Q-value adjusted ( custom Q) PRK in the other eye</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The target Q will be estimated according to a nomogram considering the patient's age</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PRK</intervention_name>
    <description>PRK using Alcon-Wavelight Excimer Laser EX 500</description>
    <arm_group_label>Q-value adjusted ( custom Q) PRK in the other eye</arm_group_label>
    <arm_group_label>topography guided PRK in one eye</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age more than 18 years&#xD;
&#xD;
          -  Myopia with up to -6.5 D with or without astigmatism up to -4.75 D&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anterior segment abnormalities (ie, cataracts, corneal scarring)&#xD;
&#xD;
          -  basement membrane disease&#xD;
&#xD;
          -  history of recurrent corneal erosions&#xD;
&#xD;
          -  Schirmer's test less than 5 mm&#xD;
&#xD;
          -  established or forme fruste keratoconus&#xD;
&#xD;
          -  macular or retinal disease&#xD;
&#xD;
          -  current use of immunosuppressive therapy&#xD;
&#xD;
          -  autoimmune disease&#xD;
&#xD;
          -  pregnancy, and lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eyecare centre</name>
      <address>
        <city>Maadi</city>
        <state>Cairo</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dar Al Oyun hospital</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Rania Elsayed Gad</investigator_full_name>
    <investigator_title>Assisstant lecturer Faculty of Medicine Helwan University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
    <mesh_term>Astigmatism</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/NCT03291873
org study id: 900800700600500400300200100900
nct id: NCT03291873
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will include patients who will undergo PRK in both eyes, for each patient each eye
      will be randomly allocated to one of 2 procedures:

      topography-guided ablation in one eye (group I) and Q-factor customized ablation in the other
      eye (group II).

      Alcon/Wavelight Light Laser Technolo¬gie (GmbH, Erlangen, Germany) will be used for
      photoablation.

      The wavelight Topolyzer (Wavelight AG, Erlan¬gen, Germany)and CSO Sirius scheimpflug camera
      combined with Placido corneal topography (CSO, Florence,Italy) will be used before and 1, 3
      and 6 months after PRK. Refrac¬tive visual outcomes and corneal aberration changes will be
      compared between the two treatment modalities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: change in Postoperative spherical equivalent depending on manifest refraction after autorefractometer
time frame: 1 , 3 and 6 months postoperative
measure: change in visual acuity using snellen chart
time frame: 1 , 3 and 6 months postoperative
measure: change in corneal wavefront aberrations
time frame: 1 , 3 and 6 months postoperative
description: assessed by topolyzer
measure: change in Q value anterior at 6mm RMS, RMS of astigmatism, RMS of coma and RMS of spherical aberrations. Strehl ratio : Qvalue,RMS,strehl ratio by CSO Sirius scheimpflug
time frame: 1,3 and 6months
description: by CSO Sirius scheimpflug
measure: change in total RMS
time frame: 1,3 and 6months
description: by CSO Sirius scheimpflug
measure: change in strehl ratio
time frame: 1,3 and 6 months
description: by CSO scheimpflug
measure: change in Q value
time frame: 1,3 and 6 months
description: assessed by topolyzer
measure: efficacy:ratio of postoperative decimal UDVA to preoperative decimal CDVA
time frame: 6 months
description: ratio of postoperative decimal UDVA to preoperative decimal CDVA
measure: contrast sensitivity
time frame: 6 months
description: cambridge low contrast sensitivity
measure: predictability
time frame: 6 months
description: eyes within 1.0 D of emmetropia
measure: safety:ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA
time frame: 6 months
description: ratio of mean preoperative decimal CDVA to mean postoperative decimal CDVA
measure: stability
time frame: 6 months
description: change of more than 0.5D over
arm group label: topography guided PRK in one eye
arm group type: Active Comparator
description: Topography-guided (placido disk- based) using T-CAT Contoura treatment.
arm group label: Q-value adjusted ( custom Q) PRK in the other eye
arm group type: Active Comparator
description: The target Q will be estimated according to a nomogram considering the patient's age
intervention type: Procedure
intervention name: PRK
description: PRK using Alcon-Wavelight Excimer Laser EX 500
arm group label: Q-value adjusted ( custom Q) PRK in the other eye
arm group label: topography guided PRK in one eye
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Rania Elsayed Gad
investigator title: Assisstant lecturer Faculty of Medicine Helwan University
mesh term: Myopia
mesh term: Astigmatism
sharing ipd: Undecided