<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/NCT01686308</url>
  </required_header>
  <id_info>
    <org_study_id>CIRCAT</org_study_id>
    <nct_id>NCT01686308</nct_id>
  </id_info>
  <brief_title>The Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans</brief_title>
  <acronym>CIRCAT</acronym>
  <official_title>The Effect of Cataract on Photoentrainment of the Circadian Rhythm in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glostrup University Hospital, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Glostrup University Hospital, Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cataract is globally the most common cause of blindness and in Denmark the operation with -&#xD;
      50.000 treatments per year - is the most common eye operation. The cause of cataract is&#xD;
      growth and denaturation of the lens proteins. This leads to an increased absorption of blue&#xD;
      light and increased light scatter. This may affect newly discovered cells in the retina that&#xD;
      are involved in the regulation of the circadian rhythm. When the internal circadian rhythm is&#xD;
      not synchronized with the external day and night a phase-shift occurs. Most people know of&#xD;
      this discomfort as jet-lag, but the consequences may be much more severe such as heighten&#xD;
      risk of cancer and cardiovascular disease.&#xD;
&#xD;
      The goal of this project is to study how the circadian regulating cells of the retina is&#xD;
      affected by cataract and by the operation. Cataract patients are studied before and after the&#xD;
      operation with questionnaires, hormone and activity measurements and with a specialized pupil&#xD;
      measurement that measures the indirect response of the circadian regulating cells to blue&#xD;
      light.&#xD;
&#xD;
      Results from this study aim to shed light on the regulatory mechanisms of the eye on the&#xD;
      circadian rhythm and how these are affected by cataract. Furthermore, choice of intraocular&#xD;
      lens is evaluated. This may have impact on clinical practise especially with regard to choice&#xD;
      of intraocular lens and widened indications for cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pupillary response to blue light</measure>
    <time_frame>1 year/1month</time_frame>
    <description>Measurement of the consensual light response to red (630 nm) and blue (470 nm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>1year/1month</time_frame>
    <description>Pittsburgh Sleep Quality Index and the Morningness Eveningness Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>1 year/1 month</time_frame>
    <description>Morningness-eveningness questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Melatonin day variety analysis</measure>
    <time_frame>1year/1month</time_frame>
    <description>Salivary samples collected with 4 hour interval during 24 hours. Analyzed for melatonin concentration with Radio Immuno Assay (RIA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actigraphy</measure>
    <time_frame>1year/1month</time_frame>
    <description>Activity measured during 7 days and 7 nights with the Spectrum Actiwatch, Respironics, Philips</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Conventional Intra Ocular Lens (IOL)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yellow Intra Ocular Lens (IOL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Yellow Intra Ocular Lens (IOL)</intervention_name>
    <description>Standard operation with blue light filter Yellow IOL implantation</description>
    <arm_group_label>Yellow Intra Ocular Lens (IOL)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Intra Ocular Lens (IOL)</intervention_name>
    <description>Standard operation with conventional IOL implantation</description>
    <arm_group_label>Conventional Intra Ocular Lens (IOL)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age related/senile bilateral cataract&#xD;
&#xD;
          -  Eligible for phaco-emulsification on both eyes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known eye disease other than cataract.&#xD;
&#xD;
          -  Known systemic disease, which may affect the retina (untreated hypertension, DM etc.)&#xD;
&#xD;
          -  Known systemic disease, which may affect the lens.&#xD;
&#xD;
          -  Known psychiatric disease.&#xD;
&#xD;
          -  Known sleep or circadian rhythm disorder, not caused by lowered blue light&#xD;
             transmission by the lens.&#xD;
&#xD;
          -  Per- and post operative complications&#xD;
&#xD;
          -  Use of drugs that may affect the sleep.&#xD;
&#xD;
        For a subpopulation also:&#xD;
&#xD;
          -  Poor cooperation.&#xD;
&#xD;
          -  Severe refraction abnormalities.&#xD;
&#xD;
          -  Previous eye surgery&#xD;
&#xD;
          -  Nystagmus&#xD;
&#xD;
          -  Congenital or acquired abnormalities of: eye lids and eye area, cornea or iris.&#xD;
&#xD;
          -  Use of medicine that may affect the pupillary response.&#xD;
&#xD;
          -  Use of drugs that may affect the pupillary response.&#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>Adam E Brøndsted, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glostrup UH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glostrup University Hospital</name>
      <address>
        <city>Glostrup</city>
        <zip>DK-2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>November 30, 2011</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>February 9, 2015</last_update_submitted>
  <last_update_submitted_qc>February 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Glostrup University Hospital, Copenhagen</investigator_affiliation>
    <investigator_full_name>Adam Elias Brøndsted</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>cataract</keyword>
  <keyword>circadian rhythm</keyword>
  <keyword>pupillometry</keyword>
  <keyword>blue light transmission</keyword>
  <keyword>questionnaire</keyword>
  <keyword>sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</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/NCT01686308
org study id: CIRCAT
nct id: NCT01686308
lead sponsor: 
has dmc: Yes
Cataract is globally the most common cause of blindness and in Denmark the operation with -
      50.000 treatments per year - is the most common eye operation. The cause of cataract is
      growth and denaturation of the lens proteins. This leads to an increased absorption of blue
      light and increased light scatter. This may affect newly discovered cells in the retina that
      are involved in the regulation of the circadian rhythm. When the internal circadian rhythm is
      not synchronized with the external day and night a phase-shift occurs. Most people know of
      this discomfort as jet-lag, but the consequences may be much more severe such as heighten
      risk of cancer and cardiovascular disease.

      The goal of this project is to study how the circadian regulating cells of the retina is
      affected by cataract and by the operation. Cataract patients are studied before and after the
      operation with questionnaires, hormone and activity measurements and with a specialized pupil
      measurement that measures the indirect response of the circadian regulating cells to blue
      light.

      Results from this study aim to shed light on the regulatory mechanisms of the eye on the
      circadian rhythm and how these are affected by cataract. Furthermore, choice of intraocular
      lens is evaluated. This may have impact on clinical practise especially with regard to choice
      of intraocular lens and widened indications for cataract surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Pupillary response to blue light
time frame: 1 year/1month
description: Measurement of the consensual light response to red (630 nm) and blue (470 nm)
measure: Questionnaire
time frame: 1year/1month
description: Pittsburgh Sleep Quality Index and the Morningness Eveningness Questionnaire
measure: Questionnaire
time frame: 1 year/1 month
description: Morningness-eveningness questionnaire
measure: Melatonin day variety analysis
time frame: 1year/1month
description: Salivary samples collected with 4 hour interval during 24 hours. Analyzed for melatonin concentration with Radio Immuno Assay (RIA).
measure: Actigraphy
time frame: 1year/1month
description: Activity measured during 7 days and 7 nights with the Spectrum Actiwatch, Respironics, Philips
arm group label: Conventional Intra Ocular Lens (IOL)
arm group type: Active Comparator
description: Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation.
arm group label: Yellow Intra Ocular Lens (IOL)
arm group type: Experimental
description: Standard minimal incision cataract surgery by phacoemulsification and posterior intraocular lens implantation.
intervention type: Procedure
intervention name: Yellow Intra Ocular Lens (IOL)
description: Standard operation with blue light filter Yellow IOL implantation
arm group label: Yellow Intra Ocular Lens (IOL)
intervention type: Procedure
intervention name: Conventional Intra Ocular Lens (IOL)
description: Standard operation with conventional IOL implantation
arm group label: Conventional Intra Ocular Lens (IOL)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adam E Brøndsted, MD
role: Principal Investigator
affiliation: Glostrup UH
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Glostrup University Hospital, Copenhagen
investigator full name: Adam Elias Brøndsted
investigator title: MD
mesh term: Cataract