<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/NCT04452279</url>
  </required_header>
  <id_info>
    <org_study_id>The OSD iStent Study</org_study_id>
    <nct_id>NCT04452279</nct_id>
  </id_info>
  <brief_title>Ocular Surface Disease Changes After iStent or iStent Inject Implantation With Phacoemulsification</brief_title>
  <official_title>Prospective Study of Ocular Surface Disease Changes After iStent or iStent Inject Trabecular Micro-Bypass Implantation With Cataract Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vance Thompson Vision</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vance Thompson Vision</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective interventional single-arm trial evaluates measures changes in ocular surface&#xD;
      disease parameters in eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma&#xD;
      medications who undergo phacoemulsification and trabecular micro-bypass stent(s) implantation&#xD;
      (iStent or iStent inject).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study enrolled eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma&#xD;
      medications who were scheduled to undergo phacoemulsification cataract extraction and&#xD;
      trabecular micro-bypass stent(s) implantation (iStent or iStent inject). Study participation&#xD;
      entailed measurement of key ocular surface data through 3 months postoperative including&#xD;
      Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema),&#xD;
      fluorescein tear break-up time (FTBUT), and conjunctival hyperemia (Efron Scale); these&#xD;
      measures were collected alongside standard postoperative glaucoma evaluations such as number&#xD;
      of glaucoma medications and intraocular pressure (IOP).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">August 15, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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 mean OSDI score</measure>
    <time_frame>3 months</time_frame>
    <description>Difference between preoperative and Month 3 mean OSDI score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean conjunctival hyperemia score</measure>
    <time_frame>3 months</time_frame>
    <description>Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean corneal/conjunctival staining score</measure>
    <time_frame>3 months</time_frame>
    <description>Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean fluorescein tear break-up time (FTBUT)</measure>
    <time_frame>3 months</time_frame>
    <description>Difference between preoperative and Month 3 mean FTBUT in seconds</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IOP change</measure>
    <time_frame>3 months</time_frame>
    <description>Difference between preoperative and Month 3 mean IOP in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication change</measure>
    <time_frame>3 months</time_frame>
    <description>Difference between preoperative and Month 3 mean number of glaucoma medications</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Ocular Surface Disease</condition>
  <condition>Glaucoma, Open-Angle</condition>
  <arm_group>
    <arm_group_label>Ocular Surface Disease post-stenting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eyes will undergo phacoemulsification cataract surgery combined with iStent or iStent inject implantation according to standard clinical practice. From baseline through 3 months postoperatively, participants will complete subjective and objective assessments of ocular surface disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iStent or iStent inject implantation with concomitant cataract surgery</intervention_name>
    <description>Standard phacoemulsification cataract surgery followed by ab interno implantation of either iStent or iStent inject trabecular micro-bypass stent(s). Preoperatively and at specified visits through 3 months postoperative, patients will complete evaluations of their ocular surface disease (specifically OSDI score, hyperemia, corneal/conjunctival staining, and tear break-up time).</description>
    <arm_group_label>Ocular Surface Disease post-stenting</arm_group_label>
    <other_name>iStent or iStent inject</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Mild to moderate primary open-angle glaucoma&#xD;
&#xD;
          2. Currently treated with ocular hypotensive medication&#xD;
&#xD;
          3. Primary open-angle, pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses&#xD;
&#xD;
          4. Subject scheduled to undergo cataract surgery in combination with one trabecular&#xD;
             meshwork bypass stent&#xD;
&#xD;
          5. 22 years of age or older&#xD;
&#xD;
          6. Able and willing to attend scheduled follow-up exams for three months postoperatively&#xD;
&#xD;
          7. Able and willing to provide written informed consent on the IRB approved Informed&#xD;
             Consent Form&#xD;
&#xD;
          8. Successful, uncomplicated cataract surgery&#xD;
&#xD;
          9. OSDI of 8 or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Primary angle-closure glaucoma; or secondary angle closure glaucoma, including&#xD;
             neovascular glaucoma 2. Any pathology for which, in the investigator's judgement, the&#xD;
             following would be either at risk or contraindicated:&#xD;
&#xD;
               1. Cataract surgery&#xD;
&#xD;
               2. Stent implantation&#xD;
&#xD;
               3. Compliance to elements of the study protocol (e.g., ophthalmic examinations,&#xD;
                  follow-up visits) 3. Fellow eye actively enrolled in this trial 4. Current&#xD;
                  participation in any study, or participation within 30 calendar days of screening&#xD;
                  exam 5. Unsuccessful, complicated cataract surgery 6. OSDI of 7 or less&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Justin Schweitzer, OD, FAAO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vance Thompson Vision</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vance Thompson Vision</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ocular surface</keyword>
  <keyword>dry eye</keyword>
  <keyword>medication</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma, Open-Angle</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/NCT04452279
org study id: The OSD iStent Study
nct id: NCT04452279
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This prospective interventional single-arm trial evaluates measures changes in ocular surface
      disease parameters in eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma
      medications who undergo phacoemulsification and trabecular micro-bypass stent(s) implantation
      (iStent or iStent inject).
This study enrolled eyes with mild to moderate open-angle glaucoma (OAG) on 1-4 glaucoma
      medications who were scheduled to undergo phacoemulsification cataract extraction and
      trabecular micro-bypass stent(s) implantation (iStent or iStent inject). Study participation
      entailed measurement of key ocular surface data through 3 months postoperative including
      Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema),
      fluorescein tear break-up time (FTBUT), and conjunctival hyperemia (Efron Scale); these
      measures were collected alongside standard postoperative glaucoma evaluations such as number
      of glaucoma medications and intraocular pressure (IOP).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in mean OSDI score
time frame: 3 months
description: Difference between preoperative and Month 3 mean OSDI score
measure: Change in mean conjunctival hyperemia score
time frame: 3 months
description: Difference between preoperative and Month 3 mean Efron score of conjunctival hyperemia
measure: Change in mean corneal/conjunctival staining score
time frame: 3 months
description: Difference between preoperative and Month 3 mean Oxford score of corneal/conjunctival hyperemia
measure: Change in mean fluorescein tear break-up time (FTBUT)
time frame: 3 months
description: Difference between preoperative and Month 3 mean FTBUT in seconds
measure: IOP change
time frame: 3 months
description: Difference between preoperative and Month 3 mean IOP in mmHg
measure: Medication change
time frame: 3 months
description: Difference between preoperative and Month 3 mean number of glaucoma medications
arm group label: Ocular Surface Disease post-stenting
arm group type: Experimental
description: Eyes will undergo phacoemulsification cataract surgery combined with iStent or iStent inject implantation according to standard clinical practice. From baseline through 3 months postoperatively, participants will complete subjective and objective assessments of ocular surface disease.
intervention type: Device
intervention name: iStent or iStent inject implantation with concomitant cataract surgery
description: Standard phacoemulsification cataract surgery followed by ab interno implantation of either iStent or iStent inject trabecular micro-bypass stent(s). Preoperatively and at specified visits through 3 months postoperative, patients will complete evaluations of their ocular surface disease (specifically OSDI score, hyperemia, corneal/conjunctival staining, and tear break-up time).
arm group label: Ocular Surface Disease post-stenting
other name: iStent or iStent inject
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Justin Schweitzer, OD, FAAO
role: Principal Investigator
affiliation: Vance Thompson Vision
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma, Open-Angle
sharing ipd: No