xml: <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/NCT06041139</url>
    </required_header>
    <id_info>
      <org_study_id>69881171</org_study_id>
      <nct_id>NCT06041139</nct_id>
    </id_info>
    <brief_title>Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy</brief_title>
    <official_title>Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Berkeley Eye Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Berkeley Eye Center</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background:&#xD;
  &#xD;
          -  The Tecnis Synergy intraocular lens (IOL) has a claim to allow patients to experience&#xD;
             continuous high-contrast vision from far through near even in low-light conditions.&#xD;
  &#xD;
          -  A J&amp;J-sponsored post marketing study done outside of the US claim superiority of range&#xD;
             of vision for the Tecnis Synergy IOL over the PanOptix IOL.&#xD;
  &#xD;
        Hypothesis:&#xD;
  &#xD;
          -  Patients with bilateral Panoptix IOLs have non-inferior distance, intermediate, and near&#xD;
             visual acuity compared to patients with bilateral Synergy IOLs in both photopic and&#xD;
             mesopic conditions with less glare, haloes, and/or starbursts.&#xD;
  &#xD;
        Unmet Medical Need:&#xD;
  &#xD;
          -  There is a need to look at patient visual outcomes and the visual disturbance profile&#xD;
             comparing trifocal technology with combined EDOF/Bifocal technology in the United&#xD;
             States.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  This is a non-interventional single center, two-arm comparative study of the outcomes&#xD;
             for patients following successful, uncomplicated cataract surgery.&#xD;
  &#xD;
          -  There will be 155 subjects enrolled in each arm (310 subjects total).&#xD;
  &#xD;
          -  Consecutive screening will be used for enrollment beginning from the first bilateral IOL&#xD;
             implanted.&#xD;
  &#xD;
          -  All testing will be at a single site with subjects coming from 4 surgeons (all use&#xD;
             similar surgical technique) at that site.&#xD;
  &#xD;
          -  Each surgeon will contribute a minimum of ten subjects per arm.&#xD;
  &#xD;
          -  Subjects will be assessed post-operatively during a minimum of five months after their&#xD;
             second-eye surgery.&#xD;
  &#xD;
          -  Binocular defocus curves will be performed from +1.00 to -4.00 in 0.50 diopter steps and&#xD;
             with +0.25 and -0.25 added.&#xD;
  &#xD;
          -  Self-reporting of visual complaints will be assessed.&#xD;
  &#xD;
          -  IOLSAT (IOL Satisfaction) and QUVID (Quality of Vision After Surgery) questionnaire will&#xD;
             be administered at the study visit.&#xD;
  &#xD;
          -  Halo and Glare simulator VS Halo &amp; Glare (visu-med.com) will be administered at the&#xD;
             study visit.&#xD;
  &#xD;
          -  All visual acuity testing will be measured in LogMar and all study technicians and&#xD;
             evaluators will be masked.&#xD;
  &#xD;
          -  PanOptix subjects will have been implanted with the toric and non-toric models.&#xD;
  &#xD;
          -  Synergy subjects will have been implanted with the toric and non-toric models.&#xD;
  &#xD;
          -  Demographic data will be collected to match the groups as closely as possible.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 12, 2022</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Binocular DCNVA (distance corrected near visual acuity) of Trifocal (Alcon PanOptix)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Binocular DCNVA of Trifocal (Alcon PanOptix). Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Binocular DCNVA of EDOF (extended depth of focus)/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Binocular DCNVA of EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Binocular BCDVA measured at 4m.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Binocular BCDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binocular DCIVA measured at 60cm.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Binocular DCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binocular UCDVA measured at 4m.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Binocular UCDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binocular UCIVA measured at 60cm.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Binocular UCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binocular UCNVA measured at 40cm.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Binocular UCNVA measured at 40cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binocular target corrected defocus curve</measure>
      <time_frame>through study completion, an average on 1 year</time_frame>
      <description>Binocular target corrected defocus curve. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient self-reported visual disturbances.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Patient self-reported visual disturbances will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient reported satisfaction by IOLSAT questionnaire.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Patient reported satisfaction by IOLSAT questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient reported satisfaction by QUVID questionnaire.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Patient reported satisfaction by QUVID questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post operative refraction.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Post operative refraction. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Spectacle independence utilizing the IOLSAT.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.</description>
    </other_outcome>
    <other_outcome>
      <measure>Halo will be reported.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Halo will be reported and assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.</description>
    </other_outcome>
    <other_outcome>
      <measure>Glare will be reported.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Glare will be reported and assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.</description>
    </other_outcome>
    <other_outcome>
      <measure>Binocular DCNVA at 33cm.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Binocular DCNVA at 33cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">310</enrollment>
    <condition>Pseudophakia</condition>
    <arm_group>
      <arm_group_label>Alcon PanOptix</arm_group_label>
      <description>Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Johnson &amp; Johnson Synergy</arm_group_label>
      <description>Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Visual Acuity</intervention_name>
      <description>Measurement of distance, intermediate and near visual acuity.</description>
      <arm_group_label>Alcon PanOptix</arm_group_label>
      <arm_group_label>Johnson &amp; Johnson Synergy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Defocus Curve</intervention_name>
      <description>Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.</description>
      <arm_group_label>Alcon PanOptix</arm_group_label>
      <arm_group_label>Johnson &amp; Johnson Synergy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Halo and Glare testing</intervention_name>
      <description>Measurement to quantify degree of visual loss caused by either halo and/or glare.</description>
      <arm_group_label>Alcon PanOptix</arm_group_label>
      <arm_group_label>Johnson &amp; Johnson Synergy</arm_group_label>
      <other_name>VS Halo &amp; Glare (visu-med.com)</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Patient Questionnaires</intervention_name>
      <description>Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.</description>
      <arm_group_label>Alcon PanOptix</arm_group_label>
      <arm_group_label>Johnson &amp; Johnson Synergy</arm_group_label>
      <other_name>IOLSAT, QUVID and Self-Reported Visual Disturbance Questionnaire</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with healthy eyes and uncomplicated bilateral implantation of Panoptix IOLs or&#xD;
          Synergy IOLs.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Are willing and able to understand and sign an informed consent&#xD;
  &#xD;
            -  Are willing and able to complete all required study visits&#xD;
  &#xD;
            -  Are more than 40 years of age&#xD;
  &#xD;
            -  Patient diagnosed with cataracts both eyes and underwent uncomplicated cataract&#xD;
               surgeries&#xD;
  &#xD;
            -  Patients with bilateral PanOptix (toric or non-toric)&#xD;
  &#xD;
            -  Patients with bilateral Synergy (toric or non-toric)&#xD;
  &#xD;
            -  Post-op best Corrected distance Visual Acuity for each eye is logMAR 0.1 (20/25) or&#xD;
               better after cataract removal.&#xD;
  &#xD;
            -  Post-op residual refractive error +0.50 - -0.50 SE with ≤ 0.75 residual refractive&#xD;
               astigmatism in each eye&#xD;
  &#xD;
            -  Minimum of two weeks post Yttrium Aluminum Garnet capsulotomy to treat posterior&#xD;
               capsular opacification&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Corneal dystrophies or degenerations&#xD;
  &#xD;
            -  Failure to return for follow up at designed intervals.&#xD;
  &#xD;
            -  Any conditions that might affect cataract removal (pseudoexfoliation, posterior polar&#xD;
               cataract, Flomax, etc.)&#xD;
  &#xD;
            -  Any conditions during surgery that might prolong the cataract removal (capsular tear,&#xD;
               inadequate pupil dilation, etc.)&#xD;
  &#xD;
            -  Strabismus with or without amblyopia in either eye&#xD;
  &#xD;
            -  Previous ocular surgery of any kind&#xD;
  &#xD;
            -  History of retinal detachment&#xD;
  &#xD;
            -  Any corneal abnormality, other than regular corneal astigmatism (as determined by&#xD;
               corneal topography) that in the opinion of the investigator would confound the&#xD;
               outcome(s) of the study&#xD;
  &#xD;
            -  Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or&#xD;
               other retinal disorders) that in the opinion of the investigator is clinically&#xD;
               significant&#xD;
  &#xD;
            -  Subjects with glaucoma&#xD;
  &#xD;
            -  Subjects who have an acute or chronic disease or illness that would confound the&#xD;
               results of this investigation (e.g. immunocompromised, connective tissue disease,&#xD;
               clinically significant atopic disease, diabetes, etc)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Morgan Micheletti, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Berkeley Eye Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Diana Hill</last_name>
      <phone>713-620-7640</phone>
      <email>diana.hill@berkeleyeye.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Berkeley Eye Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77027</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Diana Hill</last_name>
        <phone>713-620-7640</phone>
        <email>diana.hill@berkeleyeye.com</email>
      </contact>
      <investigator>
        <last_name>Morgan Micheletti, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>November 2022</verification_date>
    <study_first_submitted>July 13, 2022</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pseudophakia</keyword>
    <keyword>Alcon PanOptix</keyword>
    <keyword>Johnson &amp; Johnson Tecnis Synergy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pseudophakia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041139
  org study id: 69881171
  nct id: NCT06041139
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  Background:
  
          -  The Tecnis Synergy intraocular lens (IOL) has a claim to allow patients to experience
             continuous high-contrast vision from far through near even in low-light conditions.
  
          -  A J&J-sponsored post marketing study done outside of the US claim superiority of range
             of vision for the Tecnis Synergy IOL over the PanOptix IOL.
  
        Hypothesis:
  
          -  Patients with bilateral Panoptix IOLs have non-inferior distance, intermediate, and near
             visual acuity compared to patients with bilateral Synergy IOLs in both photopic and
             mesopic conditions with less glare, haloes, and/or starbursts.
  
        Unmet Medical Need:
  
          -  There is a need to look at patient visual outcomes and the visual disturbance profile
             comparing trifocal technology with combined EDOF/Bifocal technology in the United
             States.
  -  This is a non-interventional single center, two-arm comparative study of the outcomes
             for patients following successful, uncomplicated cataract surgery.
  
          -  There will be 155 subjects enrolled in each arm (310 subjects total).
  
          -  Consecutive screening will be used for enrollment beginning from the first bilateral IOL
             implanted.
  
          -  All testing will be at a single site with subjects coming from 4 surgeons (all use
             similar surgical technique) at that site.
  
          -  Each surgeon will contribute a minimum of ten subjects per arm.
  
          -  Subjects will be assessed post-operatively during a minimum of five months after their
             second-eye surgery.
  
          -  Binocular defocus curves will be performed from +1.00 to -4.00 in 0.50 diopter steps and
             with +0.25 and -0.25 added.
  
          -  Self-reporting of visual complaints will be assessed.
  
          -  IOLSAT (IOL Satisfaction) and QUVID (Quality of Vision After Surgery) questionnaire will
             be administered at the study visit.
  
          -  Halo and Glare simulator VS Halo & Glare (visu-med.com) will be administered at the
             study visit.
  
          -  All visual acuity testing will be measured in LogMar and all study technicians and
             evaluators will be masked.
  
          -  PanOptix subjects will have been implanted with the toric and non-toric models.
  
          -  Synergy subjects will have been implanted with the toric and non-toric models.
  
          -  Demographic data will be collected to match the groups as closely as possible.
  observational model: Case-Control
  time perspective: Prospective
  measure: Binocular DCNVA (distance corrected near visual acuity) of Trifocal (Alcon PanOptix)
  time frame: through study completion, an average of 1 year
  description: Binocular DCNVA of Trifocal (Alcon PanOptix). Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
  measure: Binocular DCNVA of EDOF (extended depth of focus)/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm
  time frame: through study completion, an average of 1 year
  description: Binocular DCNVA of EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
  measure: Binocular BCDVA measured at 4m.
  time frame: through study completion, an average of 1 year
  description: Binocular BCDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
  measure: Binocular DCIVA measured at 60cm.
  time frame: through study completion, an average of 1 year
  description: Binocular DCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
  measure: Binocular UCDVA measured at 4m.
  time frame: through study completion, an average of 1 year
  description: Binocular UCDVA measured at 4m. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
  measure: Binocular UCIVA measured at 60cm.
  time frame: through study completion, an average of 1 year
  description: Binocular UCIVA measured at 60cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
  measure: Binocular UCNVA measured at 40cm.
  time frame: through study completion, an average of 1 year
  description: Binocular UCNVA measured at 40cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
  measure: Binocular target corrected defocus curve
  time frame: through study completion, an average on 1 year
  description: Binocular target corrected defocus curve. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
  measure: Patient self-reported visual disturbances.
  time frame: through study completion, an average of 1 year
  description: Patient self-reported visual disturbances will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.
  measure: Patient reported satisfaction by IOLSAT questionnaire.
  time frame: through study completion, an average of 1 year
  description: Patient reported satisfaction by IOLSAT questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.
  measure: Patient reported satisfaction by QUVID questionnaire.
  time frame: through study completion, an average of 1 year
  description: Patient reported satisfaction by QUVID questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.
  measure: Post operative refraction.
  time frame: through study completion, an average of 1 year
  description: Post operative refraction. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
  measure: Spectacle independence utilizing the IOLSAT.
  time frame: through study completion, an average of 1 year
  description: Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.
  measure: Halo will be reported.
  time frame: through study completion, an average of 1 year
  description: Halo will be reported and assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.
  measure: Glare will be reported.
  time frame: through study completion, an average of 1 year
  description: Glare will be reported and assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score.
  measure: Binocular DCNVA at 33cm.
  time frame: through study completion, an average of 1 year
  description: Binocular DCNVA at 33cm. Visual acuity testing will be measured in LogMar and all study technicians and evaluators will be masked. A summary of the data will be prepared for all subjects and categorized by the lens implanted. Variables measured on a continuous scale will be summarized to include sample size as well as the mean, standard deviation, median, minimum and maximum.
  arm group label: Alcon PanOptix
  description: Patients will have had bilateral implantation of PanOptix IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
  arm group label: Johnson & Johnson Synergy
  description: Patients will have had bilateral implantation of Synergy IOLs with the toric and/or non-toric models at the time of uncomplicated cataract surgery.
  intervention type: Diagnostic Test
  intervention name: Visual Acuity
  description: Measurement of distance, intermediate and near visual acuity.
  arm group label: Alcon PanOptix
  arm group label: Johnson & Johnson Synergy
  intervention type: Diagnostic Test
  intervention name: Defocus Curve
  description: Measurement of visual acuity performed from +1.00 to -4.00 in 0.50 diopter steps and with +0.25 and -0.25 added.
  arm group label: Alcon PanOptix
  arm group label: Johnson & Johnson Synergy
  intervention type: Diagnostic Test
  intervention name: Halo and Glare testing
  description: Measurement to quantify degree of visual loss caused by either halo and/or glare.
  arm group label: Alcon PanOptix
  arm group label: Johnson & Johnson Synergy
  other name: VS Halo & Glare (visu-med.com)
  intervention type: Other
  intervention name: Patient Questionnaires
  description: Patients will complete a series of questionnaires to record self-reported visual disturbances, visual acuity satisfaction, level of spectacle independence and any issues with glare, halos, and/or starbursts.
  arm group label: Alcon PanOptix
  arm group label: Johnson & Johnson Synergy
  other name: IOLSAT, QUVID and Self-Reported Visual Disturbance Questionnaire
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Morgan Micheletti, MD
  role: Principal Investigator
  affiliation: Berkeley Eye Center
  last name: Diana Hill
  phone: 713-620-7640
  email: diana.hill@berkeleyeye.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Pseudophakia
  sharing ipd: No