<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/NCT04461912</url>
  </required_header>
  <id_info>
    <org_study_id>POCI-01-0145-FEDER-028758</org_study_id>
    <nct_id>NCT04461912</nct_id>
  </id_info>
  <brief_title>Ultrasonic System for Cataract Characterization and Optimal Phacoemulsification Energy Evaluation</brief_title>
  <acronym>CATARCTUS</acronym>
  <official_title>Development of a Medical Device Based on Ultrasounds for Objective Cataract Characterization and Optimal Phacoemulsification Energy Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Coimbra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação para a Ciência e a Tecnologia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Coimbra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess the performance of an ultrasonic system for automatic&#xD;
      classification of cataract type and severity, as well as the estimation of the optimal&#xD;
      phacoemulsification energy. Ultrasonic signals from the lens will be acquired with the&#xD;
      Experimental Medical Device (ESUS) in participants with cataract, and in healthy subjects&#xD;
      (control).&#xD;
&#xD;
      The proposed technique may represent an important advance in cataract treatment. The&#xD;
      quantitative and automatic classification of cataract type and severity, and the estimation&#xD;
      of the optimal phacoemulsification energy is may represent a valuable tool for surgical&#xD;
      planning, reducing complications associated to excessive levels of phacoemulsification&#xD;
      energy, as well as the times spent on surgeries. This device may be relevant not only for&#xD;
      patients, but also for public health systems, reducing waiting lists and associated costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, pivotal, non-blinded study. Fifty (50) participants will be recruited&#xD;
      at the Coimbra Surgical Center of Portugal. The study will be conducted on subjects with&#xD;
      age-related cataract, and on healthy subjects as control group. Since this is a pilot study,&#xD;
      no sample size estimation has been implemented. The statistical power will be determined at&#xD;
      the end of the study. Only per-protocol participants will be considered on statistical&#xD;
      analysis.&#xD;
&#xD;
      Procedures involved. The ultrasonic system (Experimental Medical Device - ESUS) works in&#xD;
      A-scan mode, with an acoustic working frequency of 20 MHz. From the ultrasonic signals&#xD;
      backscattered from the lenses, acoustic parameters will be extracted, and used for automatic&#xD;
      algorithms implementation. This study will be implemented once.&#xD;
&#xD;
      Slit lamp with LOCS III classification will be used as comparator. Contrast sensitivity test&#xD;
      results will be used for incipient cataract detection, where slit lamp may present some&#xD;
      limitations. Optical coherence tomography and specular microscopy will help on detecting&#xD;
      postoperative complications; other complications identified by the physician will be also&#xD;
      considered. Surgical parameters as phacoemulsification energy and surgical time will help on&#xD;
      phacoemulsification energy evaluation.&#xD;
&#xD;
      Safety assessment. The system uses an ophthalmic probe. There are not anticipated adverse&#xD;
      events related to the procedures involved in the use of the ultrasonic system, or any other&#xD;
      procedure in the protocol. The safety conditions will be monitored through the occurrence of&#xD;
      unanticipated adverse events or serious adverse events. If these situations occur, the event&#xD;
      will be reported to the competent authorities (in agreement with the current regulation) and&#xD;
      the corrective actions will be implemented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2021</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study includes participants with age-related cataract and healthy subjects as control group</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of Cataract</measure>
    <time_frame>baseline</time_frame>
    <description>Presence of cataract obtained with the Experimental Medical Device (ESUS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cataract classification</measure>
    <time_frame>baseline</time_frame>
    <description>Cataract type and severity obtained with the Experimental Medical Device (ESUS) - based on the LOCS III (Lens Opacity Classification System)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cataract hardness</measure>
    <time_frame>before the intervention/procedure/surgery</time_frame>
    <description>Cataract hardness estimated with the Experimental Medical Device (in Gpa)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phacoemulsification energy</measure>
    <time_frame>immediately after the intervention/procedure/surgery</time_frame>
    <description>Phacoemulsification energy level estimated with the Experimental Medical Device in the participants performing cataract surgery (considering the phacoemulsification energy parameters provided by the phacoemulsifier).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cataract</condition>
  <condition>Ultrasound Therapy; Complications</condition>
  <arm_group>
    <arm_group_label>Cataract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with diverse types and severities of cataract, that should realize phacoemulsification surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants on which the presence of cataract have been excluded</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Eye Scan Ultrasound System (ESUS)</intervention_name>
    <description>• For the ultrasonic signals acquisitions, an ophthalmic probe working in A-mode scan, must be coupled to the cornea. To reduce the discomfort generated by coupling the probe, topical anaesthesia (oxybuprocaine hydrochloride) will be applied before starting acquisitions. However, if the participant has some known contraindication to this anaesthetic, in replacement, a disposable neutral contact lens will be used as coupling medium between the probe and the cornea.&#xD;
The acquisitions are initiated through a starting button in the system's user interface, and the probe must be kept by few seconds for automatic signals records. During this period, signals are visualized in the user interface. Finally the probe is uncoupled, and the acquired signals are saved.</description>
    <arm_group_label>Cataract</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Cataract group:&#xD;
&#xD;
          -  Patients with age-related cataract;&#xD;
&#xD;
          -  Indication of phacoemulsification surgery&#xD;
&#xD;
        Control group:&#xD;
&#xD;
        • Patients without cataract&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        • Presence of any other ophthalmological condition or systemic disease that could affect&#xD;
        the results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miguel Caixinha, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>miguel.caixinha@gmail.com</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jaime Santos, PhD</last_name>
    <phone>+351 239 796 200</phone>
    <email>jaime@deec.uc.pt</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Miguel Caixinha, PhD</last_name>
    <email>miguel.caixinha@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centro Cirúrgico de Coimbra (CCCI)</name>
      <address>
        <city>Coimbra</city>
        <country>Portugal</country>
      </address>
    </facility>
    <contact>
      <last_name>António Travassos, MD</last_name>
    </contact>
    <investigator>
      <last_name>António Travassos, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Coimbra</investigator_affiliation>
    <investigator_full_name>Jaime Batista Santos</investigator_full_name>
    <investigator_title>Investigator Responsible</investigator_title>
  </responsible_party>
  <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/NCT04461912
org study id: POCI-01-0145-FEDER-028758
nct id: NCT04461912
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to assess the performance of an ultrasonic system for automatic
      classification of cataract type and severity, as well as the estimation of the optimal
      phacoemulsification energy. Ultrasonic signals from the lens will be acquired with the
      Experimental Medical Device (ESUS) in participants with cataract, and in healthy subjects
      (control).

      The proposed technique may represent an important advance in cataract treatment. The
      quantitative and automatic classification of cataract type and severity, and the estimation
      of the optimal phacoemulsification energy is may represent a valuable tool for surgical
      planning, reducing complications associated to excessive levels of phacoemulsification
      energy, as well as the times spent on surgeries. This device may be relevant not only for
      patients, but also for public health systems, reducing waiting lists and associated costs.
This is a prospective, pivotal, non-blinded study. Fifty (50) participants will be recruited
      at the Coimbra Surgical Center of Portugal. The study will be conducted on subjects with
      age-related cataract, and on healthy subjects as control group. Since this is a pilot study,
      no sample size estimation has been implemented. The statistical power will be determined at
      the end of the study. Only per-protocol participants will be considered on statistical
      analysis.

      Procedures involved. The ultrasonic system (Experimental Medical Device - ESUS) works in
      A-scan mode, with an acoustic working frequency of 20 MHz. From the ultrasonic signals
      backscattered from the lenses, acoustic parameters will be extracted, and used for automatic
      algorithms implementation. This study will be implemented once.

      Slit lamp with LOCS III classification will be used as comparator. Contrast sensitivity test
      results will be used for incipient cataract detection, where slit lamp may present some
      limitations. Optical coherence tomography and specular microscopy will help on detecting
      postoperative complications; other complications identified by the physician will be also
      considered. Surgical parameters as phacoemulsification energy and surgical time will help on
      phacoemulsification energy evaluation.

      Safety assessment. The system uses an ophthalmic probe. There are not anticipated adverse
      events related to the procedures involved in the use of the ultrasonic system, or any other
      procedure in the protocol. The safety conditions will be monitored through the occurrence of
      unanticipated adverse events or serious adverse events. If these situations occur, the event
      will be reported to the competent authorities (in agreement with the current regulation) and
      the corrective actions will be implemented.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The study includes participants with age-related cataract and healthy subjects as control group
primary purpose: Diagnostic
masking: None (Open Label)
measure: Presence of Cataract
time frame: baseline
description: Presence of cataract obtained with the Experimental Medical Device (ESUS)
measure: Cataract classification
time frame: baseline
description: Cataract type and severity obtained with the Experimental Medical Device (ESUS) - based on the LOCS III (Lens Opacity Classification System)
measure: Cataract hardness
time frame: before the intervention/procedure/surgery
description: Cataract hardness estimated with the Experimental Medical Device (in Gpa)
measure: Phacoemulsification energy
time frame: immediately after the intervention/procedure/surgery
description: Phacoemulsification energy level estimated with the Experimental Medical Device in the participants performing cataract surgery (considering the phacoemulsification energy parameters provided by the phacoemulsifier).
arm group label: Cataract
arm group type: Experimental
description: Participants with diverse types and severities of cataract, that should realize phacoemulsification surgery
arm group label: Control
arm group type: Placebo Comparator
description: Participants on which the presence of cataract have been excluded
intervention type: Device
intervention name: Eye Scan Ultrasound System (ESUS)
description: • For the ultrasonic signals acquisitions, an ophthalmic probe working in A-mode scan, must be coupled to the cornea. To reduce the discomfort generated by coupling the probe, topical anaesthesia (oxybuprocaine hydrochloride) will be applied before starting acquisitions. However, if the participant has some known contraindication to this anaesthetic, in replacement, a disposable neutral contact lens will be used as coupling medium between the probe and the cornea.
The acquisitions are initiated through a starting button in the system's user interface, and the probe must be kept by few seconds for automatic signals records. During this period, signals are visualized in the user interface. Finally the probe is uncoupled, and the acquired signals are saved.
arm group label: Cataract
arm group label: Control
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Miguel Caixinha, PhD
role: Principal Investigator
affiliation: miguel.caixinha@gmail.com
last name: Jaime Santos, PhD
phone: +351 239 796 200
email: jaime@deec.uc.pt
last name: Miguel Caixinha, PhD
email: miguel.caixinha@gmail.com
facility: 
contact: 
investigator: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: University of Coimbra
investigator full name: Jaime Batista Santos
investigator title: Investigator Responsible
mesh term: Cataract
sharing ipd: No