<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/NCT01706237</url>
  </required_header>
  <id_info>
    <org_study_id>NVS-SOVR-001</org_study_id>
    <nct_id>NCT01706237</nct_id>
  </id_info>
  <brief_title>Visual Outcomes And Contrast Sensitivity After Myopic Wavefront-Optimized Lasik With Nexisvision Shield Or Bandage Contact Lens</brief_title>
  <official_title>Evaluation Of Visual Outcomes And Contrast Sensitivity After Myopic Wavefront-Optimized Lasik With Nexisvision Shield Or Bandage Contact Lens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Durrie Vision</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nexisvision</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Durrie Vision</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic&#xD;
      LASIK with a Nexisvision Shield or bandage contact lens placed postoperatively. Early speed&#xD;
      of visual recovery results indicate that the visual recovery in the first 4 hours after the&#xD;
      LASIK procedure show the most variability. A patient's ability to drive after their LASIK&#xD;
      procedure would potentially alleviate a challenge that patients often face in taking&#xD;
      additional time off work or simply finding a ride to there LASIK procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laser in situ keratomileusis (LASIK) surgery has been performed worldwide since 1990.&#xD;
      Historically, LASIK has been reported to decrease contrast sensitivity post operatively and&#xD;
      patients have been advised to take the day off of work and potentially the day after LASIK.&#xD;
      More recently, utilizing advanced laser technology for optimized corneal ablation and&#xD;
      creation of the flap has the potential for improved LASIK surgery results and improved&#xD;
      recovery time. Visual recovery and management of immediate post operative visual acuity is&#xD;
      important for patient satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Nexis Vision was unable to provide the shields to continue with the study.&#xD;
  </why_stopped>
  <start_date>May 2012</start_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 4</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>Visual Acuity over time</measure>
    <time_frame>Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours</time_frame>
    <description>Progress of the change in visual acuity will be measured at specific time intervals directly after LASIK surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Contrast Sensitivity</measure>
    <time_frame>Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours</time_frame>
    <description>Change in contrast sensitivity compared to baseline will be documented at specific time intervals beginning immediately after LASIK surgery.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Shield</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A shield (similar to a contact lens) is placed on the eye after myopic LASIK procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nexisvision shield</intervention_name>
    <description>A shield is placed on the eye after LASIK. The shield is similar to a contact lens.</description>
    <arm_group_label>Shield</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
          -  Male or female in good general health, 18 years of age or older at the time of the&#xD;
             pre-operative examination&#xD;
&#xD;
          -  Patient must be able to read, comprehend and willing to give HIPPA and informed&#xD;
             consent&#xD;
&#xD;
          -  Patient is planning to undergo a bilateral LASIK procedure&#xD;
&#xD;
          -  Both eyes must have a manifest refractive error from -1.00 D to -7.00 spherical&#xD;
             equivalent with less than or equal to 3.00D of refractive astigmatism as expressed in&#xD;
             spectacle minus cylinder form&#xD;
&#xD;
          -  Both eyes must have a BSCVA of 20/20 or better&#xD;
&#xD;
          -  Both eyes must demonstrate refractive stability confirmed by clinical records,&#xD;
             previous glasses, or investigator's discretion.&#xD;
&#xD;
          -  Patient must be willing to comply with study dosing and complete the entire course of&#xD;
             the study.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  A patient with evidence of keratoconus, corneal irregularity, or abnormal&#xD;
             videokeratography in either eye&#xD;
&#xD;
          -  A patient seeking monovision&#xD;
&#xD;
          -  A patient with a known hypersensitivity to any of the components of the procedural or&#xD;
             post-LASIK medications&#xD;
&#xD;
          -  A patient requiring the use of any ocular drop(s) and/or medication(s) in either eye&#xD;
             during the study period with the exception of ocular drops and/or medications provided&#xD;
             by the investigator&#xD;
&#xD;
          -  A patient having any surgical procedure within a week preceding the scheduled LASIK&#xD;
             surgery&#xD;
&#xD;
          -  A patient with any UNCONTROLLED systemic disease (i.e., a potential patient in whom&#xD;
             therapy for a systemic disease is not yet stabilized )&#xD;
&#xD;
          -  A patient with a history of prior intraocular or corneal surgery (including cataract&#xD;
             extraction), active ophthalmic disease or abnormality (including, but not limited to,&#xD;
             blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization &gt; 1mm&#xD;
             from limbus), clinically significant lens opacity, clinical evidence of trauma&#xD;
             (including scarring), or evidence of glaucoma or propensity for narrow angle glaucoma&#xD;
             in either eye&#xD;
&#xD;
          -  A patient with a significant history or current evidence of a medical, psychological&#xD;
             or other disorder that, in the investigator's opinion, may increase the risk&#xD;
             associated with study participation or may interfere with the interpretation of study&#xD;
             results&#xD;
&#xD;
          -  A patient with a history of any of the following medical conditions, or any other&#xD;
             condition that could affect wound healing: uncontrolled diabetes, collagen vascular&#xD;
             disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or&#xD;
             simplex, endocrine disorders (including, but not limited to unstable thyroid disorders&#xD;
             and diabetes), lupus, and rheumatoid arthritis&#xD;
&#xD;
          -  Current participation or participation within 30 days prior to the start of this study&#xD;
             in a drug or other investigational research study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel S Durrie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Durrie Vision</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen G. Slade, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Slade &amp; Baker Vision</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>June 3, 2014</last_update_submitted>
  <last_update_submitted_qc>June 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myopia</keyword>
  <keyword>LASIK</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</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/NCT01706237
org study id: NVS-SOVR-001
nct id: NCT01706237
lead sponsor: 
collaborator: 
has dmc: No
Evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic
      LASIK with a Nexisvision Shield or bandage contact lens placed postoperatively. Early speed
      of visual recovery results indicate that the visual recovery in the first 4 hours after the
      LASIK procedure show the most variability. A patient's ability to drive after their LASIK
      procedure would potentially alleviate a challenge that patients often face in taking
      additional time off work or simply finding a ride to there LASIK procedure.
Laser in situ keratomileusis (LASIK) surgery has been performed worldwide since 1990.
      Historically, LASIK has been reported to decrease contrast sensitivity post operatively and
      patients have been advised to take the day off of work and potentially the day after LASIK.
      More recently, utilizing advanced laser technology for optimized corneal ablation and
      creation of the flap has the potential for improved LASIK surgery results and improved
      recovery time. Visual recovery and management of immediate post operative visual acuity is
      important for patient satisfaction.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Acuity over time
time frame: Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours
description: Progress of the change in visual acuity will be measured at specific time intervals directly after LASIK surgery.
measure: Contrast Sensitivity
time frame: Immediate, 30 minutes, 1 hour, 2 hour, and 4 hours
description: Change in contrast sensitivity compared to baseline will be documented at specific time intervals beginning immediately after LASIK surgery.
arm group label: Shield
arm group type: Experimental
description: A shield (similar to a contact lens) is placed on the eye after myopic LASIK procedure.
intervention type: Device
intervention name: Nexisvision shield
description: A shield is placed on the eye after LASIK. The shield is similar to a contact lens.
arm group label: Shield
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel S Durrie, MD
role: Principal Investigator
affiliation: Durrie Vision
last name: Stephen G. Slade, MD
role: Principal Investigator
affiliation: Slade & Baker Vision
country: United States
responsible party type: Sponsor
mesh term: Myopia