<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/NCT03751215</url>
  </required_header>
  <id_info>
    <org_study_id>Clareon</org_study_id>
    <nct_id>NCT03751215</nct_id>
  </id_info>
  <brief_title>Anterior Chamber Depth Variability Between Two Lenses With Different Materials</brief_title>
  <official_title>Anterior Chamber Depth (ACD) Variability Between the Clareon and Acrysof IOL: a Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prim. Prof. Dr. Oliver Findl, MBA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vienna Institute for Research in Ocular Surgery</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare the change of the Anterior chamber depth (ACD) variability between the Clareon and&#xD;
      the AcrySof Intraocular lens (IOL) after implantation over 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing cataract surgery are often otherwise healthy and active with their only&#xD;
      restriction being reduced visual quality. Within the past few years, intraocular lenses&#xD;
      (IOLs) have been improved to fulfill the needs of these patients. Nowadays efforts are aiming&#xD;
      for the enhancement of the patient vision and his subjective satisfaction postoperative.&#xD;
&#xD;
      One of the best ways to accomplish this is to have a perfect intraocular lens (IOL) power&#xD;
      calculation. However, the best calculation can't help if the implanted intraocular lens (IOL)&#xD;
      changes its position after implantation.&#xD;
&#xD;
      It should be considered that an anterior chamber depth (ACD) shift, decentration, tilt or&#xD;
      rotation of an IOL could result in a reduction in visual quality. For an aspherical IOL, for&#xD;
      instance, it is essential not to be decentrated and tilted more than 0.4 mm 2 (0.8 mm 3) and&#xD;
      7° 2 (10° 3), respectively. Otherwise it will be outperformed by a spherical IOL. The&#xD;
      estimation of the post-operative intraocular lens (IOL) position and therefore the estimated&#xD;
      anterior chamber depth (ACD) is presently the main source of error (35% 4 to 42% 5) in IOL&#xD;
      power calculation and therefore for the refractive outcome of the patients after cataract&#xD;
      surgery. Presently the pre-operatively measured ACD is taken into account for several IOL&#xD;
      power calculation formulas, such as the Haigis formula, the Holladay II formula and the Olsen&#xD;
      formula.&#xD;
&#xD;
      To manage a better outcome an IOL with less postoperative influence of the anterior chamber&#xD;
      depth (ACD) is very important. To accomplish a smaller deviation after the operation of the&#xD;
      anterior chamber depth (ACD) the haptic and the material of the lens is very important. The&#xD;
      change of the anterior chamber depth (ACD) after cataract surgery can be easily measured by&#xD;
      instruments like the IOL-Master 700, AC-Master and Lenstar. It must be considered that every&#xD;
      person is different and that change of the anterior chamber depth (ACD) in different eyes can&#xD;
      cause high measurement errors. The changes in two eyes of the same patient help to minimize&#xD;
      the error. These can help to achieve a better outcome for future patients.&#xD;
&#xD;
      The hydrophobic acrylate of the Acrysof IOL has been modified to the new material in the&#xD;
      Clareon IOL. This study will evaluate whether the new Clareon has non-inferior axial&#xD;
      stability to the Acrysof.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</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>Anterior chamber depth (ACD)</measure>
    <time_frame>12 months</time_frame>
    <description>The change in anterior chamber depth (ACD) before and after cataract surgery will be measured using the IOL Master 700 and compared between the two different IOLs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distance visual acuity</measure>
    <time_frame>12 months</time_frame>
    <description>Uncorrected and corrected distance visual acuity will be determined using ETDRS-charts in a distance of 4 metres and differences in refraction will be compared between the two IOLs.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cataract</condition>
  <arm_group>
    <arm_group_label>Monofocal IOL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be implanted with two different monofocal lenses (Clareon and AcrySof) during cataract surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cataract surgery</intervention_name>
    <description>During cataract surgery the patient is implanted with the monofocal IOL Clareon in one eye and the monofocal IOL AcrySof in the contralateral eye</description>
    <arm_group_label>Monofocal IOL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age-related cataract in both eyes&#xD;
&#xD;
          -  Scheduled for bilateral cataract surgery&#xD;
&#xD;
          -  Age 21 and older&#xD;
&#xD;
          -  Written informed consent prior to recruitment&#xD;
&#xD;
          -  Visual Acuity &gt; 0.05&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)&#xD;
&#xD;
          -  Any ophthalmic abnormality that could compromise visual function or the measurements&#xD;
&#xD;
          -  Presence of potential zonular weakness such as pseudoexfoliation Syndrome, history of&#xD;
             ocular trauma, previous ocular surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Julius Hienert, MD</last_name>
    <phone>01/ 91021/ 57564</phone>
    <email>office@viros.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Manuel Ruiß, MSc.</last_name>
    <phone>01/ 91021/ 57564</phone>
    <email>office@viros.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vienna Institute for Research in Ocular Surgery (VIROS)</name>
      <address>
        <city>Vienna</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julius Hienert, MD</last_name>
      <phone>01/ 91021/ 57564</phone>
      <email>office@viros.at</email>
    </contact>
    <contact_backup>
      <last_name>Manuel Ruiß, MSc.</last_name>
      <phone>01/ 91021/ 57564</phone>
      <email>office@viros.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Vienna Institute for Research in Ocular Surgery</investigator_affiliation>
    <investigator_full_name>Prim. Prof. Dr. Oliver Findl, MBA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cataract</keyword>
  <keyword>Cataract surgery</keyword>
  <keyword>Intraocular lens</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>Undecided</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/NCT03751215
org study id: Clareon
nct id: NCT03751215
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Compare the change of the Anterior chamber depth (ACD) variability between the Clareon and
      the AcrySof Intraocular lens (IOL) after implantation over 6 months.
Patients undergoing cataract surgery are often otherwise healthy and active with their only
      restriction being reduced visual quality. Within the past few years, intraocular lenses
      (IOLs) have been improved to fulfill the needs of these patients. Nowadays efforts are aiming
      for the enhancement of the patient vision and his subjective satisfaction postoperative.

      One of the best ways to accomplish this is to have a perfect intraocular lens (IOL) power
      calculation. However, the best calculation can't help if the implanted intraocular lens (IOL)
      changes its position after implantation.

      It should be considered that an anterior chamber depth (ACD) shift, decentration, tilt or
      rotation of an IOL could result in a reduction in visual quality. For an aspherical IOL, for
      instance, it is essential not to be decentrated and tilted more than 0.4 mm 2 (0.8 mm 3) and
      7° 2 (10° 3), respectively. Otherwise it will be outperformed by a spherical IOL. The
      estimation of the post-operative intraocular lens (IOL) position and therefore the estimated
      anterior chamber depth (ACD) is presently the main source of error (35% 4 to 42% 5) in IOL
      power calculation and therefore for the refractive outcome of the patients after cataract
      surgery. Presently the pre-operatively measured ACD is taken into account for several IOL
      power calculation formulas, such as the Haigis formula, the Holladay II formula and the Olsen
      formula.

      To manage a better outcome an IOL with less postoperative influence of the anterior chamber
      depth (ACD) is very important. To accomplish a smaller deviation after the operation of the
      anterior chamber depth (ACD) the haptic and the material of the lens is very important. The
      change of the anterior chamber depth (ACD) after cataract surgery can be easily measured by
      instruments like the IOL-Master 700, AC-Master and Lenstar. It must be considered that every
      person is different and that change of the anterior chamber depth (ACD) in different eyes can
      cause high measurement errors. The changes in two eyes of the same patient help to minimize
      the error. These can help to achieve a better outcome for future patients.

      The hydrophobic acrylate of the Acrysof IOL has been modified to the new material in the
      Clareon IOL. This study will evaluate whether the new Clareon has non-inferior axial
      stability to the Acrysof.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anterior chamber depth (ACD)
time frame: 12 months
description: The change in anterior chamber depth (ACD) before and after cataract surgery will be measured using the IOL Master 700 and compared between the two different IOLs.
measure: Distance visual acuity
time frame: 12 months
description: Uncorrected and corrected distance visual acuity will be determined using ETDRS-charts in a distance of 4 metres and differences in refraction will be compared between the two IOLs.
arm group label: Monofocal IOL
arm group type: Experimental
description: Patients will be implanted with two different monofocal lenses (Clareon and AcrySof) during cataract surgery
intervention type: Procedure
intervention name: Cataract surgery
description: During cataract surgery the patient is implanted with the monofocal IOL Clareon in one eye and the monofocal IOL AcrySof in the contralateral eye
arm group label: Monofocal IOL
criteria: 
gender: All
minimum age: 21 Years
maximum age: 105 Years
healthy volunteers: No
last name: Julius Hienert, MD
phone: 01/ 91021/ 57564
email: office@viros.at
last name: Manuel Ruiß, MSc.
phone: 01/ 91021/ 57564
email: office@viros.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Vienna Institute for Research in Ocular Surgery
investigator full name: Prim. Prof. Dr. Oliver Findl, MBA
investigator title: Principal Investigator
mesh term: Cataract
sharing ipd: Undecided