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/NCT05988827</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00815-40</org_study_id>
      <nct_id>NCT05988827</nct_id>
    </id_info>
    <brief_title>Effect of Minimizing Light Exposure Intensity on Macular Function After Cataract Surgery in Patients With Early or Intermediate AMD</brief_title>
    <acronym>EMERGING</acronym>
    <official_title>Effect of Minimizing Light Exposure Intensity of 3D Digital Visualization (NGenuity) on Macular Function After Cataract Surgery in Patients With Early or Intermediate AMD: A Comparative ERG</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Elsan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Alcon Research</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Elsan</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>
        Cataract surgery is one of the most frequently performed surgical interventions worldwide.&#xD;
        The microscope light-induced retinal toxicity after cataract surgery has been described in&#xD;
        several reports even in short procedures; however, this potential toxicity has not been&#xD;
        evaluated by objective criteria. Indeed, this retinal phototoxicity would be increased for&#xD;
        patients with mild macular diseases such as early stages of AMD (Aged Macular Degeneration)&#xD;
        (ie: drusen) which are frequently associated in elderly patients with cataract.&#xD;
  &#xD;
        The aim of the study will be to assess the potential functional macular effects by focal and&#xD;
        multifocal ERG after cataract surgery with NGenuity by comparison to Standard Operating&#xD;
        Microscope (SOM). This study would particularly address eyes at risk for macular toxicity&#xD;
        like patients with early or intermediate AMD&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cataract surgery is one of the most frequently performed surgical interventions worldwide.&#xD;
        The development of phacoemulsification technology, instrumentation and surgical techniques&#xD;
        has improved both the efficacy and safety of procedures, reducing rates of serious&#xD;
        postoperative adverse events. The microscope light-induced retinal toxicity after cataract&#xD;
        surgery has been described in several reports even in short procedures; however, this&#xD;
        potential toxicity has not been evaluated by objective criteria. Indeed, this retinal&#xD;
        phototoxicity would be increased for patients with mild macular diseases such as early stages&#xD;
        of AMD (Aged Macular Degeneration) (ie: drusen) which are frequently associated in elderly&#xD;
        patients with cataract. A systematic literature review of 129 664 individuals estimated the&#xD;
        prevalence of early macular degeneration to 8.01% in population aged 45 to 85 years. A&#xD;
        three-dimensional (3D) heads-up system (NGenuity®, Alcon, Fort Worth, TX) was recently&#xD;
        introduced for both vitreoretinal and cataract surgery, radically improving the quality of&#xD;
        surgical visualization. This system allows performing cataract surgery at a lower fraction of&#xD;
        light intensity reducing patient's photophobia complaints during surgery and probably&#xD;
        preventing potential phototoxic macular injury in cataract surgery. In a recent pilot study,&#xD;
        the Ngenuity system was reported to decrease significantly the operative light intensity and&#xD;
        to contribute to a faster visual recovery relative to traditional microscopes in series of 35&#xD;
        patients (51 eyes) who underwent cataract surgery. The aim of the study will be to assess the&#xD;
        potential functional macular effects by focal and multifocal ERG after cataract surgery with&#xD;
        NGenuity by comparison to Standard Operating Microscope (SOM). This study would particularly&#xD;
        address eyes at risk for macular toxicity like patients :&#xD;
  &#xD;
          -  with early AMD: medium-sized drusen (between 63µm and 125µm in diameter) without&#xD;
             pigmentary abnormalities&#xD;
  &#xD;
          -  with intermediate AMD : large drusen (&gt;125 µm) or pigmentary abnormalities in the retina&#xD;
             associated with at least medium drusen&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Prospective, randomized, 2-arm controlled, parallel, single-masked, single-center study</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participant is not aware about the light exposure used during the surgery (NGenuity or SOM)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Assess the change from baseline of the retinal response amplitude in voltage in patients one hour after cataract surgery performed with NGenuity compared to standard light condition with SOM.</measure>
      <time_frame>1 hour after cataract surgery</time_frame>
      <description>The change from baseline of the photopic b-wave amplitude (µV) measured one hour after the cataract surgery by fERG.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assess the change from baseline in both arms of amplitude of the response in voltage in patients one day and one month after cataract surgery</measure>
      <time_frame>1 day and 1 month after cataract surgery</time_frame>
      <description>The change from baseline of photopic b-wave amplitude (µV) measured at postoperative day and 1 month after surgery by fERG</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess the change from baseline in both arms of latency of response in time in patients one hour, one day and one month after cataract surgery</measure>
      <time_frame>1 hour, 1 day and 1 month after cataract surgery</time_frame>
      <description>The change from baseline in both arms of fERG implicit time (msec) measured at one hour, one day and one month after cataract surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess the change from baseline in both arms of total photoreceptors response in the macula one day and one month after cataract surgery</measure>
      <time_frame>1 day and 1 month after cataract surgery</time_frame>
      <description>The change from baseline in both arms of Multifocal ERG amplitude (µV) measured at one day and one month after cataract surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess the change from baseline in both arms of visual acuity one hour, one day and one month after cataract surgery.</measure>
      <time_frame>1 hour, 1 day and 1 month after cataract surgery</time_frame>
      <description>The change from baseline in both arms of visual acuity measured on 10 scale one hour, one day and one month after cataract surgery.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Macular Degeneration, Age Related</condition>
    <condition>Cataract</condition>
    <arm_group>
      <arm_group_label>NGenuity</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>NGenuity allowing a reduced light intensity to 15% during cataract surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SOM</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>microscope without NGenuity with light intensity of 60%, similar to a Standad Operating Microscope (SOM)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NGenuity</intervention_name>
      <description>Cataract surgery performed under microscope using NGenuity</description>
      <arm_group_label>NGenuity</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient undergoing cataract surgery and presenting signs of early AMD with&#xD;
               medium-sized drusen (between 63 µm and 125 µm in diameter) or intermediate AMD with&#xD;
               large drusen (&gt;125 µm) or pigmentary abnormalities with at least medium sized drusen&#xD;
               in the study eye.&#xD;
  &#xD;
            -  Patient affiliated to health care system&#xD;
  &#xD;
            -  Patient with signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children under 18 years old&#xD;
  &#xD;
            -  AMD defined by geographic atrophy or pigment epithelium detachment, subretinal&#xD;
               hemorrhage or visible subretinal new vessel, or subretinal fibrous scars in the study&#xD;
               eye&#xD;
  &#xD;
            -  Non-age-related cataracts&#xD;
  &#xD;
            -  History of previous ocular surgery, anterior segment (corneal, anterior chamber,&#xD;
               sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal&#xD;
               vascular occlusive disease, retinal detachment or peripheral retinal laser&#xD;
               photocoagulation, neovascular AMD, glaucoma in the study eye&#xD;
  &#xD;
            -  Any current anterior or posterior segment inflammation of any etiology, and/or history&#xD;
               of any disease producing an intraocular inflammatory reaction.&#xD;
  &#xD;
            -  Patient with conditions that increase the risk of zonular rupture during cataract&#xD;
               extraction procedure that may affect the postoperative centration or tilt of the IOL&#xD;
  &#xD;
            -  Patient treated by plaquenil&#xD;
  &#xD;
            -  Patient already enrolled in the same study for one eye&#xD;
  &#xD;
            -  Patient already enrolled in clinical trial or with exclusion period in progress&#xD;
  &#xD;
            -  Patient under guardianship, curatorship or other legal protection, deprived of liberty&#xD;
               by judicial or administrative decision&#xD;
  &#xD;
            -  Pregnant or breastfeeding women&#xD;
  &#xD;
            -  Patient hospitalized without consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Otman Sandali, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hopital Prive Guillaume de Varye ELSAN</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Otman Sandali, MD</last_name>
      <phone>33 2 48 70 83 86</phone>
      <email>sanotman1@yahoo.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hopital privé Guillaume de Varye</name>
        <address>
          <city>Saint-Doulchard</city>
          <zip>18230</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Otman SANDALI, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cataract, AMD, light exposure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Macular Degeneration</mesh_term>
      <mesh_term>Cataract</mesh_term>
      <mesh_term>Capsule Opacification</mesh_term>
    </condition_browse>
    <!-- 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/NCT05988827
  org study id: 2023-A00815-40
  nct id: NCT05988827
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Cataract surgery is one of the most frequently performed surgical interventions worldwide.
        The microscope light-induced retinal toxicity after cataract surgery has been described in
        several reports even in short procedures; however, this potential toxicity has not been
        evaluated by objective criteria. Indeed, this retinal phototoxicity would be increased for
        patients with mild macular diseases such as early stages of AMD (Aged Macular Degeneration)
        (ie: drusen) which are frequently associated in elderly patients with cataract.
  
        The aim of the study will be to assess the potential functional macular effects by focal and
        multifocal ERG after cataract surgery with NGenuity by comparison to Standard Operating
        Microscope (SOM). This study would particularly address eyes at risk for macular toxicity
        like patients with early or intermediate AMD
  Cataract surgery is one of the most frequently performed surgical interventions worldwide.
        The development of phacoemulsification technology, instrumentation and surgical techniques
        has improved both the efficacy and safety of procedures, reducing rates of serious
        postoperative adverse events. The microscope light-induced retinal toxicity after cataract
        surgery has been described in several reports even in short procedures; however, this
        potential toxicity has not been evaluated by objective criteria. Indeed, this retinal
        phototoxicity would be increased for patients with mild macular diseases such as early stages
        of AMD (Aged Macular Degeneration) (ie: drusen) which are frequently associated in elderly
        patients with cataract. A systematic literature review of 129 664 individuals estimated the
        prevalence of early macular degeneration to 8.01% in population aged 45 to 85 years. A
        three-dimensional (3D) heads-up system (NGenuity®, Alcon, Fort Worth, TX) was recently
        introduced for both vitreoretinal and cataract surgery, radically improving the quality of
        surgical visualization. This system allows performing cataract surgery at a lower fraction of
        light intensity reducing patient's photophobia complaints during surgery and probably
        preventing potential phototoxic macular injury in cataract surgery. In a recent pilot study,
        the Ngenuity system was reported to decrease significantly the operative light intensity and
        to contribute to a faster visual recovery relative to traditional microscopes in series of 35
        patients (51 eyes) who underwent cataract surgery. The aim of the study will be to assess the
        potential functional macular effects by focal and multifocal ERG after cataract surgery with
        NGenuity by comparison to Standard Operating Microscope (SOM). This study would particularly
        address eyes at risk for macular toxicity like patients :
  
          -  with early AMD: medium-sized drusen (between 63µm and 125µm in diameter) without
             pigmentary abnormalities
  
          -  with intermediate AMD : large drusen (>125 µm) or pigmentary abnormalities in the retina
             associated with at least medium drusen
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, randomized, 2-arm controlled, parallel, single-masked, single-center study
  primary purpose: Prevention
  masking: Single (Participant)
  masking description: Participant is not aware about the light exposure used during the surgery (NGenuity or SOM)
  measure: Assess the change from baseline of the retinal response amplitude in voltage in patients one hour after cataract surgery performed with NGenuity compared to standard light condition with SOM.
  time frame: 1 hour after cataract surgery
  description: The change from baseline of the photopic b-wave amplitude (µV) measured one hour after the cataract surgery by fERG.
  measure: Assess the change from baseline in both arms of amplitude of the response in voltage in patients one day and one month after cataract surgery
  time frame: 1 day and 1 month after cataract surgery
  description: The change from baseline of photopic b-wave amplitude (µV) measured at postoperative day and 1 month after surgery by fERG
  measure: Assess the change from baseline in both arms of latency of response in time in patients one hour, one day and one month after cataract surgery
  time frame: 1 hour, 1 day and 1 month after cataract surgery
  description: The change from baseline in both arms of fERG implicit time (msec) measured at one hour, one day and one month after cataract surgery
  measure: Assess the change from baseline in both arms of total photoreceptors response in the macula one day and one month after cataract surgery
  time frame: 1 day and 1 month after cataract surgery
  description: The change from baseline in both arms of Multifocal ERG amplitude (µV) measured at one day and one month after cataract surgery
  measure: Assess the change from baseline in both arms of visual acuity one hour, one day and one month after cataract surgery.
  time frame: 1 hour, 1 day and 1 month after cataract surgery
  description: The change from baseline in both arms of visual acuity measured on 10 scale one hour, one day and one month after cataract surgery.
  arm group label: NGenuity
  arm group type: Experimental
  description: NGenuity allowing a reduced light intensity to 15% during cataract surgery
  arm group label: SOM
  arm group type: No Intervention
  description: microscope without NGenuity with light intensity of 60%, similar to a Standad Operating Microscope (SOM)
  intervention type: Device
  intervention name: NGenuity
  description: Cataract surgery performed under microscope using NGenuity
  arm group label: NGenuity
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Otman Sandali, MD
  role: Principal Investigator
  affiliation: Hopital Prive Guillaume de Varye ELSAN
  last name: Otman Sandali, MD
  phone: 33 2 48 70 83 86
  email: sanotman1@yahoo.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Macular Degeneration
  mesh term: Cataract
  mesh term: Capsule Opacification