<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/NCT04425551</url>
  </required_header>
  <id_info>
    <org_study_id>6/19</org_study_id>
    <nct_id>NCT04425551</nct_id>
  </id_info>
  <brief_title>Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction</brief_title>
  <official_title>Prospective Study of the Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Naval Hospital, Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Naval Hospital, Athens</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 modern treatment of meibomian gland dysfunction(MGD) is based on anti-inflammatory drops&#xD;
      or oral antibiotics for decreasing dry eye disease (DED) associated inflammation, warm&#xD;
      compresses for liquefying the thicker meibum, and lid hygiene for reducing the bacterial&#xD;
      overload. But, such treatments have shown limited effectiveness to a large proportion of&#xD;
      patients with MGD, due to the multifactorial background of the disease. Thus, alternative&#xD;
      approaches aiming at different aspects of the DED pathophysiology are needed.&#xD;
&#xD;
      Elimination of posterior lid-margin hyperemia with telangiectasia could be a treatment target&#xD;
      for reducing the secretion of inflammatory mediators in the course of MGD. Using the&#xD;
      mechanism of photocoagulation via selective thermolysis, laser light could contribute to the&#xD;
      destruction of abnormal vessels at the posterior lid-margin and thus, the reduction of&#xD;
      inflammation. Recently, sub-threshold (micropulse) laser photocoagulation was introduced in&#xD;
      ophthalmology and offers significant clinical advantages compared to conventional continuous&#xD;
      wave (CW) approach, preventing laser induced thermal damage and related treatment side&#xD;
      effects.&#xD;
&#xD;
      This study investigates the effect of sub-threshold (micropulse) laser treatment for dry eye&#xD;
      disease due to meibomian gland dysfunction combined with increased eyelid margin vascularity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 5, 2019</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Each participant's clinically worse eye was selected for treatment, while the other eye was observed as control. If both eyes were clinically same, one of them was randomly selected.&#xD;
*Please note that there was one group of participants, but two groups of eyes (treated/untreated). Thus, PARALLEL was selected, referring to eyes, not participants</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Lower Eyelid Margin Vascularity</measure>
    <time_frame>Baseline, Day 0 after treatment, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment</time_frame>
    <description>Lower Eyelid Margin Vascularity is measured with ImageJ® software for vessels analysis from photographs of lower eyelid margin. Vascularity is evaluated as percentage (%) of lower eyelid margin surface. Time points are referred at ''Time Frame'' section.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular Surface Disease Index (OSDI)</measure>
    <time_frame>Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment</time_frame>
    <description>scale (0-100). Higher values represent greater disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear Break Up Time (TBUT)</measure>
    <time_frame>Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment</time_frame>
    <description>time (seconds). Higher values represent greater disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower Eyelid Tear Meniscus Height</measure>
    <time_frame>Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment</time_frame>
    <description>height (μm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meibomography</measure>
    <time_frame>Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment</time_frame>
    <description>scale (0,1,2,3). Higher values represent greater disability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Dry Eye</condition>
  <condition>Dry Eye Syndromes</condition>
  <condition>Meibomian Gland Dysfunction</condition>
  <arm_group>
    <arm_group_label>Treated</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The lower eyelid margin of the clinically worse eye was selected for treatment. A slit lamp based 532 nm optically pumped dual diode solid state SP-Mode (subthreshold) laser system was used. After cleaning eyelids with a cosmetic face wash, a drop of proparacaine hydrochloride 0.5% was then administered onto the conjunctival sac. No eye or cornea shield was used, since laser light was directly aimed at telangiectasias.&#xD;
The treatment parameters were set with 50 μm spot size and 200 ms duration with 30% duty cycle. The power ranged from 1500 to 1700 mW with monospot micropulse model and a just visible destruction of the telangiectatic vessels served as the threshold burn.&#xD;
After the procedure, the patient received corticosteroid ointment for 5 days on both eyes and was advised to continue applying her pre-treatment medication on both eyes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Untreated</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The lateral eye was observed as control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laser light</intervention_name>
    <description>laser light destruction of telangiectatic vessels of lower eyelid margin via selective thermolysis</description>
    <arm_group_label>Treated</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-80 years&#xD;
&#xD;
          -  chief complaint of more than one of dryness, foreign-body sensation, burning, and&#xD;
             tearing for 3 months&#xD;
&#xD;
          -  diagnosis of MGD with palpebral telangiectasia in both eyes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ocular structural abnormalities&#xD;
&#xD;
          -  history of ocular trauma or surgery&#xD;
&#xD;
          -  use of any treatment for DE or MGD, other than artificial tears, within the past month&#xD;
&#xD;
          -  active allergy, infection, or inflammatory disease at the ocular surface unrelated to&#xD;
             DE or MGD&#xD;
&#xD;
          -  lacrimal drainage-system anomalies&#xD;
&#xD;
          -  contact-lens wear&#xD;
&#xD;
          -  use of any systemic anti-inflammatory medicine&#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>Nikolaos Kappos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Naval Hospital, Athens</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naval Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <zip>11521</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Naval Hospital, Athens</investigator_affiliation>
    <investigator_full_name>Nikolaos Kappos</investigator_full_name>
    <investigator_title>Ophthalmology Resident, Clinical Investigator</investigator_title>
  </responsible_party>
  <keyword>dry eye</keyword>
  <keyword>meibomian gland dysfunction</keyword>
  <keyword>laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
    <mesh_term>Meibomian Gland Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04425551
org study id: 6/19
nct id: NCT04425551
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The modern treatment of meibomian gland dysfunction(MGD) is based on anti-inflammatory drops
      or oral antibiotics for decreasing dry eye disease (DED) associated inflammation, warm
      compresses for liquefying the thicker meibum, and lid hygiene for reducing the bacterial
      overload. But, such treatments have shown limited effectiveness to a large proportion of
      patients with MGD, due to the multifactorial background of the disease. Thus, alternative
      approaches aiming at different aspects of the DED pathophysiology are needed.

      Elimination of posterior lid-margin hyperemia with telangiectasia could be a treatment target
      for reducing the secretion of inflammatory mediators in the course of MGD. Using the
      mechanism of photocoagulation via selective thermolysis, laser light could contribute to the
      destruction of abnormal vessels at the posterior lid-margin and thus, the reduction of
      inflammation. Recently, sub-threshold (micropulse) laser photocoagulation was introduced in
      ophthalmology and offers significant clinical advantages compared to conventional continuous
      wave (CW) approach, preventing laser induced thermal damage and related treatment side
      effects.

      This study investigates the effect of sub-threshold (micropulse) laser treatment for dry eye
      disease due to meibomian gland dysfunction combined with increased eyelid margin vascularity.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Each participant's clinically worse eye was selected for treatment, while the other eye was observed as control. If both eyes were clinically same, one of them was randomly selected.
*Please note that there was one group of participants, but two groups of eyes (treated/untreated). Thus, PARALLEL was selected, referring to eyes, not participants
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Lower Eyelid Margin Vascularity
time frame: Baseline, Day 0 after treatment, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
description: Lower Eyelid Margin Vascularity is measured with ImageJ® software for vessels analysis from photographs of lower eyelid margin. Vascularity is evaluated as percentage (%) of lower eyelid margin surface. Time points are referred at ''Time Frame'' section.
measure: Ocular Surface Disease Index (OSDI)
time frame: Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
description: scale (0-100). Higher values represent greater disability.
measure: Tear Break Up Time (TBUT)
time frame: Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
description: time (seconds). Higher values represent greater disability.
measure: Lower Eyelid Tear Meniscus Height
time frame: Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
description: height (μm)
measure: Meibomography
time frame: Baseline, Day 14 after treatment, Day 30 after treatment, Day 60 after treatment
description: scale (0,1,2,3). Higher values represent greater disability.
arm group label: Treated
arm group type: Active Comparator
description: The lower eyelid margin of the clinically worse eye was selected for treatment. A slit lamp based 532 nm optically pumped dual diode solid state SP-Mode (subthreshold) laser system was used. After cleaning eyelids with a cosmetic face wash, a drop of proparacaine hydrochloride 0.5% was then administered onto the conjunctival sac. No eye or cornea shield was used, since laser light was directly aimed at telangiectasias.
The treatment parameters were set with 50 μm spot size and 200 ms duration with 30% duty cycle. The power ranged from 1500 to 1700 mW with monospot micropulse model and a just visible destruction of the telangiectatic vessels served as the threshold burn.
After the procedure, the patient received corticosteroid ointment for 5 days on both eyes and was advised to continue applying her pre-treatment medication on both eyes.
arm group label: Untreated
arm group type: No Intervention
description: The lateral eye was observed as control.
intervention type: Procedure
intervention name: laser light
description: laser light destruction of telangiectatic vessels of lower eyelid margin via selective thermolysis
arm group label: Treated
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nikolaos Kappos, MD
role: Principal Investigator
affiliation: Naval Hospital, Athens
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Naval Hospital, Athens
investigator full name: Nikolaos Kappos
investigator title: Ophthalmology Resident, Clinical Investigator
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases
mesh term: Meibomian Gland Dysfunction
sharing ipd: No