<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/NCT03805425</url>
  </required_header>
  <id_info>
    <org_study_id>PiXLHyperopia</org_study_id>
    <nct_id>NCT03805425</nct_id>
  </id_info>
  <brief_title>PiXL for Correction of Hyperopia</brief_title>
  <official_title>Photorefractive Intrastromal Corneal Crosslinking (PiXL) for Correction of Hyperopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gemini Eye Clinic</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gemini Eye Clinic</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>
      This clinical study aims to investigate the efficacy and safety of PiXL in the refractive&#xD;
      correction of low hyperopia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical study aims to investigate the efficacy and safety of PiXL in the refractive&#xD;
      correction of low hyperopia.Slightly modified settings from previously published study is&#xD;
      applied to eyes with low hyperopia with an expected refractive change of 0.75 D. Aim is to&#xD;
      evaluate the refractive outcome of this procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Actual">December 2020</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>Change in Uncorrected Distance Visual Acuity</measure>
    <time_frame>Month 12</time_frame>
    <description>Best distance visual acuity tested without any correction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Subjective Refraction</measure>
    <time_frame>Month 12</time_frame>
    <description>Spherical and cylindrical correction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in keratometry</measure>
    <time_frame>Month 12</time_frame>
    <description>Change in keratomery parameter K2-K1provided by Pentacam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Higher Order Aberrations</measure>
    <time_frame>Month 12</time_frame>
    <description>Higher Order Aberrations assessed using Pentacam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pachymetry</measure>
    <time_frame>Month 12</time_frame>
    <description>Change in mean cornea thickness in 8.0 mm ring provided by Pentacam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective questionnaire score</measure>
    <time_frame>Month 12</time_frame>
    <description>Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Corrected Distance Visual Acuity</measure>
    <time_frame>Month 12</time_frame>
    <description>Best distance visual acuity tested with the best correction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Spherical aberration</measure>
    <time_frame>Month 12</time_frame>
    <description>Spherical aberration assessed using Pentacam</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Hyperopia</condition>
  <arm_group>
    <arm_group_label>Photorefractive intrastromal corneal crosslinking (PiXL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo PiXL where the UVA light is delivered in customized patterns and corneal changes are achieved. For hyperopia, a ring shape irradiation is used to steepen the central cornea. An oxygen mask is used to enhance the crosslinking efficacy. A dedicated riboflavin formulation penetrates the corneal stroma. Pulsed UVA light with oxygen triggers the covalent bonds of collagen strands in riboflavin soaked cornea.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>PiXL</intervention_name>
    <description>The system is set to deliver 30 mW/cm2 UVA irradiance in pulsed intervals of 1 second on and 1 second off to 5 to 9 mm diameter corneal annulus. Total energy delivered is 15J.</description>
    <arm_group_label>Photorefractive intrastromal corneal crosslinking (PiXL)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  low hyperopia of spherical equivalent from +0.5 up to +1.75 D sp. eq.&#xD;
&#xD;
          -  astigmatism up to 0.75 Dcyl&#xD;
&#xD;
          -  corneal thickness above 400 µm&#xD;
&#xD;
          -  endothelial cell density above 1500 cell/mm2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any prior corneal surgery or any eye surgery within the last 3 months,&#xD;
&#xD;
          -  any corneal pathology e.g. corneal scar or dystrophy&#xD;
&#xD;
          -  unstable refraction&#xD;
&#xD;
          -  patient not able to understand and sign informed consent&#xD;
&#xD;
          -  patients with connective tissue disorder or uncontrolled diabetes&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
&#xD;
          -  aphakic eyes or pseudophakic eyes without UV blocking IOL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pavel Stodulka, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gemini Eye Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gemini Eye Clinic</name>
      <address>
        <city>Zlín</city>
        <zip>760 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Kanellopoulos AJ, Asimellis G. Hyperopic correction: clinical validation with epithelium-on and epithelium-off protocols, using variable fluence and topographically customized collagen corneal crosslinking. Clin Ophthalmol. 2014 Dec 2;8:2425-33. doi: 10.2147/OPTH.S68222. eCollection 2014.</citation>
    <PMID>25506204</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypeorpia</keyword>
  <keyword>Crosslinking</keyword>
  <keyword>PiXL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperopia</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/NCT03805425
org study id: PiXLHyperopia
nct id: NCT03805425
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive
      correction of low hyperopia.
This clinical study aims to investigate the efficacy and safety of PiXL in the refractive
      correction of low hyperopia.Slightly modified settings from previously published study is
      applied to eyes with low hyperopia with an expected refractive change of 0.75 D. Aim is to
      evaluate the refractive outcome of this procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Uncorrected Distance Visual Acuity
time frame: Month 12
description: Best distance visual acuity tested without any correction
measure: Change in Subjective Refraction
time frame: Month 12
description: Spherical and cylindrical correction
measure: Change in keratometry
time frame: Month 12
description: Change in keratomery parameter K2-K1provided by Pentacam
measure: Change in Higher Order Aberrations
time frame: Month 12
description: Higher Order Aberrations assessed using Pentacam
measure: Change in pachymetry
time frame: Month 12
description: Change in mean cornea thickness in 8.0 mm ring provided by Pentacam
measure: Subjective questionnaire score
time frame: Month 12
description: Questionnaire assessing participants discomfort at 6 months in respect to their photophobia, pain and dry eye.
measure: Change in Corrected Distance Visual Acuity
time frame: Month 12
description: Best distance visual acuity tested with the best correction
measure: Change in Spherical aberration
time frame: Month 12
description: Spherical aberration assessed using Pentacam
arm group label: Photorefractive intrastromal corneal crosslinking (PiXL)
arm group type: Experimental
description: Patients undergo PiXL where the UVA light is delivered in customized patterns and corneal changes are achieved. For hyperopia, a ring shape irradiation is used to steepen the central cornea. An oxygen mask is used to enhance the crosslinking efficacy. A dedicated riboflavin formulation penetrates the corneal stroma. Pulsed UVA light with oxygen triggers the covalent bonds of collagen strands in riboflavin soaked cornea.
intervention type: Radiation
intervention name: PiXL
description: The system is set to deliver 30 mW/cm2 UVA irradiance in pulsed intervals of 1 second on and 1 second off to 5 to 9 mm diameter corneal annulus. Total energy delivered is 15J.
arm group label: Photorefractive intrastromal corneal crosslinking (PiXL)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pavel Stodulka, MD, PhD
role: Principal Investigator
affiliation: Gemini Eye Clinic
facility: 
country: Czechia
citation: Kanellopoulos AJ, Asimellis G. Hyperopic correction: clinical validation with epithelium-on and epithelium-off protocols, using variable fluence and topographically customized collagen corneal crosslinking. Clin Ophthalmol. 2014 Dec 2;8:2425-33. doi: 10.2147/OPTH.S68222. eCollection 2014.
PMID: 25506204
responsible party type: Sponsor
mesh term: Hyperopia