<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/NCT02970487</url>
  </required_header>
  <id_info>
    <org_study_id>2015-0023</org_study_id>
    <nct_id>NCT02970487</nct_id>
  </id_info>
  <brief_title>Precisight® Intraocular Lens Implantation for Cataract Treatment</brief_title>
  <acronym>PEACE</acronym>
  <official_title>Refractive Outcome and Optimization of IOL-Constants After Implantation of the Precisight® Intraocular Lens.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InfiniteVision Optics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Targomed</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>InfiniteVision Optics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the refractive outcomes and optimize the clinical&#xD;
      features of a new intraocular lens intended to treat the senile cataract.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      InfiniteVision Optics has developed a new IOL system, the Precisight IOL. This IOL consists&#xD;
      of a combination of two lenses: a base lens which is placed permanently into the capsular&#xD;
      bag, and a front lens which sits on top of the base lens outside the capsular bag. The major&#xD;
      advantage of this system is the adjustability of the primary IOL implantation which is done&#xD;
      by front lens exchange. In case of either postoperative refractive adjustments or patient&#xD;
      dissatisfaction with the visual performance, the front lens can be easily exchange by a less&#xD;
      invasive surgery, avoiding a total IOL explantation. The implantation of the Precisight IOL&#xD;
      is similar to the implantation of a traditional intraocular lens with no expected additional&#xD;
      risk.&#xD;
&#xD;
      For all new IOLs, the IOL-constants are determined and provided by the manufacturer. They are&#xD;
      calculated on the basis of eye models and clinical testing. In this study the biometric data&#xD;
      of each patient's eye will be documented together with the implanted lens power and the&#xD;
      postoperative stable refraction for calculation of the optimized IOL-constants.&#xD;
&#xD;
      In the present study, 125 subjects will be enrolled. Patients with a deviation from target&#xD;
      refraction of more than 0.5 D spherical equivalent at the 2-3 month follow-up visit will&#xD;
      undergo a secondary intervention for exchange of the front lens. These patients will be&#xD;
      followed up for 1 year after front lens exchange.&#xD;
&#xD;
      Subjects will be screened during a pre-operative visit. Before the surgery visit, the&#xD;
      subjected must have signed the Informed Consent Form.&#xD;
&#xD;
      After the surgery, patients will be followed up for one year. The visits will be scheduled at&#xD;
      1 day, 7-14 days, 2-3 months and 5-7 months and 1 year after surgery. Patients who underwent&#xD;
      a surgery to exchange the front lens will be also followed up 1 day, 7-14 days, 2-3 months&#xD;
      and 5-7 months and 1 year after the exchange surgery.&#xD;
&#xD;
      Investigator site staff will document the data in electronic Case Report Forms (eCRF). The&#xD;
      data will be pseudonymized, i.e. only the year of birth and a code will be entered in the&#xD;
      eCRF. Adverse events will be recorded in an eCRFs. Unexpected and serious adverse events are&#xD;
      to be reported to the manufacturer.&#xD;
&#xD;
      Data cleaning will be done one month after last patient out and study report finished three&#xD;
      months after last patient out. Subjects must be withdrawn from the study (i) at their own&#xD;
      request, (ii) in case of intraoperative complication impacting the safety of the patient or&#xD;
      (iii) in case of any postoperative complication if the continuation of the study has an&#xD;
      impact on the safety of the patient. The study may terminate before completion if a high&#xD;
      relative number of individual subject withdrawals due to the patient's requests and/or&#xD;
      clinically relevant complications are observed. The IRB will be informed in due course&#xD;
      accordingly.&#xD;
&#xD;
      The findings of this study will be published by the investigators in a scientific journal and&#xD;
      presented at scientific meetings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">January 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 of the subjective refraction</measure>
    <time_frame>2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation</time_frame>
    <description>The evolution of subjective refraction will be assessed after Precisight implantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best-corrected distance visual acuity</measure>
    <time_frame>1 day, 7 to 14 days, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Introcular lens (IOL) decentration and tilt</measure>
    <time_frame>day of surgery, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anterior chamber depth</measure>
    <time_frame>pre-operative, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>All follow up period (1 year)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of investigator regarding handling and achievement of target refraction</measure>
    <time_frame>Six months after investigational device implantation</time_frame>
    <description>The investigator shall answer a questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Cataract Senile</condition>
  <arm_group>
    <arm_group_label>investigational device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects implanted with the Precisight intraocular lens.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intraocular implant of the Precisight</intervention_name>
    <description>Precisight ismplanted in place of the natural cloudy lens, inside the capsular bag.</description>
    <arm_group_label>investigational device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age-related bilateral cataract or one pseudophakic eye&#xD;
&#xD;
          -  Visual acuity potential of the study eye of at least 0.63 (decimal)&#xD;
&#xD;
          -  Expected postoperative astigmatism of ≤0.75 D in the study eye&#xD;
&#xD;
          -  IOL power within available diopters&#xD;
&#xD;
          -  Written informed patient consent regarding participation in the study and data&#xD;
             protection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visually significant corneal scars&#xD;
&#xD;
          -  Ocular disorders - other than cataract - that could potentially cause future acuity&#xD;
             losses to a level of 0.5 (decimal) or worse in the study eye&#xD;
&#xD;
          -  Relevant concomitant ophthalmic diseases (such as pseudoexfoliation, angleclosure&#xD;
             glaucoma, traumatic cataract and other co-morbidity that could affect capsular bag&#xD;
             stability (e.g. Marfan syndrome)&#xD;
&#xD;
          -  Participation of patient in other clinical trials (former participation is not an&#xD;
             exclusion criterion)&#xD;
&#xD;
          -  Any cataract condition that makes the assessment of retina status difficult&#xD;
&#xD;
          -  Anyone with unstable systemic conditions or untreated systemic medical problems&#xD;
             including but not limited to the following: Untreated diabetes, Cardiovascular&#xD;
             untreated disease, Pulmonary untreated disease, Any untreated infection,&#xD;
             Neuro-ophthalmologic diseases, Any allergy to the medications used during surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harvey S Uy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peregrine Eye and Laser Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peregrine Eye and Laser Institue</name>
      <address>
        <city>Makati</city>
        <zip>1209</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>February 28, 2019</last_update_submitted>
  <last_update_submitted_qc>February 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cataract</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</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/NCT02970487
org study id: 2015-0023
nct id: NCT02970487
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the refractive outcomes and optimize the clinical
      features of a new intraocular lens intended to treat the senile cataract.
InfiniteVision Optics has developed a new IOL system, the Precisight IOL. This IOL consists
      of a combination of two lenses: a base lens which is placed permanently into the capsular
      bag, and a front lens which sits on top of the base lens outside the capsular bag. The major
      advantage of this system is the adjustability of the primary IOL implantation which is done
      by front lens exchange. In case of either postoperative refractive adjustments or patient
      dissatisfaction with the visual performance, the front lens can be easily exchange by a less
      invasive surgery, avoiding a total IOL explantation. The implantation of the Precisight IOL
      is similar to the implantation of a traditional intraocular lens with no expected additional
      risk.

      For all new IOLs, the IOL-constants are determined and provided by the manufacturer. They are
      calculated on the basis of eye models and clinical testing. In this study the biometric data
      of each patient's eye will be documented together with the implanted lens power and the
      postoperative stable refraction for calculation of the optimized IOL-constants.

      In the present study, 125 subjects will be enrolled. Patients with a deviation from target
      refraction of more than 0.5 D spherical equivalent at the 2-3 month follow-up visit will
      undergo a secondary intervention for exchange of the front lens. These patients will be
      followed up for 1 year after front lens exchange.

      Subjects will be screened during a pre-operative visit. Before the surgery visit, the
      subjected must have signed the Informed Consent Form.

      After the surgery, patients will be followed up for one year. The visits will be scheduled at
      1 day, 7-14 days, 2-3 months and 5-7 months and 1 year after surgery. Patients who underwent
      a surgery to exchange the front lens will be also followed up 1 day, 7-14 days, 2-3 months
      and 5-7 months and 1 year after the exchange surgery.

      Investigator site staff will document the data in electronic Case Report Forms (eCRF). The
      data will be pseudonymized, i.e. only the year of birth and a code will be entered in the
      eCRF. Adverse events will be recorded in an eCRFs. Unexpected and serious adverse events are
      to be reported to the manufacturer.

      Data cleaning will be done one month after last patient out and study report finished three
      months after last patient out. Subjects must be withdrawn from the study (i) at their own
      request, (ii) in case of intraoperative complication impacting the safety of the patient or
      (iii) in case of any postoperative complication if the continuation of the study has an
      impact on the safety of the patient. The study may terminate before completion if a high
      relative number of individual subject withdrawals due to the patient's requests and/or
      clinically relevant complications are observed. The IRB will be informed in due course
      accordingly.

      The findings of this study will be published by the investigators in a scientific journal and
      presented at scientific meetings.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of the subjective refraction
time frame: 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
description: The evolution of subjective refraction will be assessed after Precisight implantation.
measure: Best-corrected distance visual acuity
time frame: 1 day, 7 to 14 days, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
measure: Introcular lens (IOL) decentration and tilt
time frame: day of surgery, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
measure: Anterior chamber depth
time frame: pre-operative, 2 to 3 months, 5 to 7 months and 1 year after the investigational device implantation
measure: Adverse events
time frame: All follow up period (1 year)
measure: Assessment of investigator regarding handling and achievement of target refraction
time frame: Six months after investigational device implantation
description: The investigator shall answer a questionnaire.
arm group label: investigational device
arm group type: Experimental
description: Subjects implanted with the Precisight intraocular lens.
intervention type: Device
intervention name: Intraocular implant of the Precisight
description: Precisight ismplanted in place of the natural cloudy lens, inside the capsular bag.
arm group label: investigational device
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Harvey S Uy, MD
role: Principal Investigator
affiliation: Peregrine Eye and Laser Institute
facility: 
country: Philippines
responsible party type: Sponsor
mesh term: Cataract
sharing ipd: No