<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/NCT04436198</url>
  </required_header>
  <id_info>
    <org_study_id>FWH20200112H</org_study_id>
    <nct_id>NCT04436198</nct_id>
  </id_info>
  <brief_title>Capsular Tension Rings in Intraocular Lens Rotation</brief_title>
  <official_title>The Investigation of Capsular Tension Rings in Intraocular Lens Rotation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rachel Lieberman</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mike O'Callaghan Military Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To investigate whether implantation of a capsular tension ring device will affect the degree&#xD;
      of rotation of an implanted toric intraocular lens following cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, subject-blinded investigation of whether implanting capsular&#xD;
      tension rings with intraocular lenses affects rotational stability of the lens.&#xD;
&#xD;
      Lens Selection: The patients will undergo standard of care preoperative measurements and&#xD;
      planning. The surgeon will evaluate preoperative measurements and use lens calculations, as&#xD;
      well as a discussion with the patient, to identify whether a toric lens will be used and to&#xD;
      determine the IOL power, cylinder, and target axis (standard of care). Preoperative&#xD;
      measurements will be taken using IOL-Master 700, with the addition of the Pentacam and&#xD;
      automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS&#xD;
      IOL. It will be used on label (standard of care).&#xD;
&#xD;
      Randomization: Each eye undergoing cataract surgery will be randomized into a control or&#xD;
      treatment group. If both eyes meet enrollment criteria, then each eye will be randomized&#xD;
      independently.&#xD;
&#xD;
        -  Control group: toric IOL only&#xD;
&#xD;
        -  Treatment group: toric IOL plus capsular tension ring&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    no longer feasible&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">April 21, 2023</completion_date>
  <primary_completion_date type="Actual">April 21, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>degree of toric rotation away from target axis in enrolled eye/s</measure>
    <time_frame>6 months</time_frame>
    <description>The eye(s) enrolled in the study will be dilated and slit lamp photography taken using retroillumination.&#xD;
The capsular tension ring will not be visible in the slit lamp photos or during the eye exams. The patient will be blinded as to which eye is in the treatment or control group. The slit lamp photos will be de-identified and used to determine the axis of the toric IOL by evaluators blinded to the patient identity and control/treatment group. The toric axis will be identified using either ImageJ (NIH) or Adobe Illustrator by measuring the angle between a straight line drawn across the toric axis markers and a straight line at the horizontal axis (0 degrees).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Cataract</condition>
  <condition>Ophthalmoplegia</condition>
  <condition>Ophthalmologic Complication</condition>
  <arm_group>
    <arm_group_label>Treatment group: toric IOL plus capsular tension ring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group: toric IOL only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MORCHER® EYEJET® CTR Types 14, 14A, and 14C</intervention_name>
    <description>Intervention. Toric IOL + CTR. Whether the subject receives 14, 14A, or 14C is an either or scenario depending on the eye's axial length and is a single intervention:&#xD;
Axial length &gt; 28.0 mm: CTR model 14A Axial length 24.0-28.0 mm: CTR model 14C Axial length &lt; 24.0 mm: CTR model 14&#xD;
Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).</description>
    <arm_group_label>Treatment group: toric IOL plus capsular tension ring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Toric IOL Only</intervention_name>
    <description>Control. Toric IOL only. Standard of care cataract surgery without placement of a capsular tension ring.&#xD;
Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).</description>
    <arm_group_label>Control group: toric IOL only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        **Patients must be able to get care at Nellis Air Force Base (a military installation) in&#xD;
        order to participate in this study**&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Active duty and DoD beneficiaries aged 30 years or older undergoing cataract surgery&#xD;
&#xD;
          -  Corneal astigmatism ≥ 1.0 D and a surgical plan that includes a toric intraocular lens&#xD;
             for astigmatism correction. (The lens used will be the TECNIS IOL. It will be used on&#xD;
             label)&#xD;
&#xD;
          -  No observed zonular or capsular problems prior to, or at the time of, capsular tension&#xD;
             ring insertion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing cataract surgery who do not have corneal astigmatism ≥1.0 D.&#xD;
&#xD;
          -  Any observed zonular or capsular problems prior to, or at the time of, capsular&#xD;
             tension ring insertion.&#xD;
&#xD;
          -  Pre-existing ocular conditions, including:Pre-existing ocular conditions, including:&#xD;
&#xD;
               -  Pseudoexfoliation syndrome in one or both eyes&#xD;
&#xD;
               -  Prior incisional ocular surgery&#xD;
&#xD;
               -  Lens subluxation&#xD;
&#xD;
               -  Poor dilation or inability to position at the slit lamp (making postoperative&#xD;
                  outcome measurements difficult or impossible)&#xD;
&#xD;
               -  Plans for extensive travel or to move away during the postoperative evaluation&#xD;
                  period&#xD;
&#xD;
               -  Other conditions that would influence the capsule or lens positioning&#xD;
&#xD;
          -  Surgical plan to include other procedures at the time of initial cataract surgery,&#xD;
             such as Limbal Relaxing Incisions (LRIs), Micro-Incisional Glaucoma Surgery (MIGS),&#xD;
             etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel A Lieberman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>United States Air Force</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mike O'Callaghan Military Medical Center</name>
      <address>
        <city>Nellis Air Force Base</city>
        <state>Nevada</state>
        <zip>89191</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Novis C. Astigmatism and toric intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):47-50. doi: 10.1097/00055735-200002000-00007.</citation>
    <PMID>10724827</PMID>
  </reference>
  <reference>
    <citation>Shimizu K, Misawa A, Suzuki Y. Toric intraocular lenses: correcting astigmatism while controlling axis shift. J Cataract Refract Surg. 1994 Sep;20(5):523-6. doi: 10.1016/s0886-3350(13)80232-5.</citation>
    <PMID>7996408</PMID>
  </reference>
  <reference>
    <citation>Holland E, Lane S, Horn JD, Ernest P, Arleo R, Miller KM. The AcrySof Toric intraocular lens in subjects with cataracts and corneal astigmatism: a randomized, subject-masked, parallel-group, 1-year study. Ophthalmology. 2010 Nov;117(11):2104-11. doi: 10.1016/j.ophtha.2010.07.033. Epub 2010 Sep 16.</citation>
    <PMID>20846724</PMID>
  </reference>
  <reference>
    <citation>Felipe A, Artigas JM, Diez-Ajenjo A, Garcia-Domene C, Alcocer P. Residual astigmatism produced by toric intraocular lens rotation. J Cataract Refract Surg. 2011 Oct;37(10):1895-901. doi: 10.1016/j.jcrs.2011.04.036. Epub 2011 Aug 23.</citation>
    <PMID>21865007</PMID>
  </reference>
  <reference>
    <citation>Rastogi A, Khanam S, Goel Y; Kamlesh; Thacker P, Kumar P. Comparative evaluation of rotational stability and visual outcome of toric intraocular lenses with and without a capsular tension ring. Indian J Ophthalmol. 2018 Mar;66(3):411-415. doi: 10.4103/ijo.IJO_875_17.</citation>
    <PMID>29480253</PMID>
  </reference>
  <reference>
    <citation>Shah GD, Praveen MR, Vasavada AR, Vasavada VA, Rampal G, Shastry LR. Rotational stability of a toric intraocular lens: influence of axial length and alignment in the capsular bag. J Cataract Refract Surg. 2012 Jan;38(1):54-9. doi: 10.1016/j.jcrs.2011.08.028. Epub 2011 Nov 4.</citation>
    <PMID>22055077</PMID>
  </reference>
  <reference>
    <citation>Zhao Y, Li J, Yang K, Li X, Zhu S. Combined Special Capsular Tension Ring and Toric IOL Implantation for Management of Astigmatism and High Axial Myopia with Cataracts. Semin Ophthalmol. 2018;33(3):389-394. doi: 10.1080/08820538.2016.1247181. Epub 2016 Dec 22.</citation>
    <PMID>28005433</PMID>
  </reference>
  <reference>
    <citation>Safran SG. Use of Capsular Tension Ring to Prevent Early Post-operative Rotation of a Toric Intraocular Lens in High Axial Myopia. JCRS Online Case reports. 2015.</citation>
  </reference>
  <reference>
    <citation>Sagiv O, Sachs D. Rotation stability of a toric intraocular lens with a second capsular tension ring. J Cataract Refract Surg. 2015 May;41(5):1098-9. doi: 10.1016/j.jcrs.2015.04.004. Epub 2015 Apr 28.</citation>
    <PMID>25937341</PMID>
  </reference>
  <reference>
    <citation>Jung NY, Lim DH, Hwang SS, Hyun J, Chung TY. Comparison of clinical outcomes of toric intraocular lens, Precizon vs Tecnis: a single center randomized controlled trial. BMC Ophthalmol. 2018 Nov 9;18(1):292. doi: 10.1186/s12886-018-0955-3.</citation>
    <PMID>30413154</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mike O'Callaghan Military Hospital</investigator_affiliation>
    <investigator_full_name>Rachel Lieberman</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>ophthalmology</keyword>
  <keyword>capsular tension ring</keyword>
  <keyword>rotation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmoplegia</mesh_term>
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We do not plan on sharing data.</ipd_description>
  </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/NCT04436198
org study id: FWH20200112H
nct id: NCT04436198
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
To investigate whether implantation of a capsular tension ring device will affect the degree
      of rotation of an implanted toric intraocular lens following cataract surgery.
The study is a prospective, subject-blinded investigation of whether implanting capsular
      tension rings with intraocular lenses affects rotational stability of the lens.

      Lens Selection: The patients will undergo standard of care preoperative measurements and
      planning. The surgeon will evaluate preoperative measurements and use lens calculations, as
      well as a discussion with the patient, to identify whether a toric lens will be used and to
      determine the IOL power, cylinder, and target axis (standard of care). Preoperative
      measurements will be taken using IOL-Master 700, with the addition of the Pentacam and
      automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS
      IOL. It will be used on label (standard of care).

      Randomization: Each eye undergoing cataract surgery will be randomized into a control or
      treatment group. If both eyes meet enrollment criteria, then each eye will be randomized
      independently.

        -  Control group: toric IOL only

        -  Treatment group: toric IOL plus capsular tension ring
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: degree of toric rotation away from target axis in enrolled eye/s
time frame: 6 months
description: The eye(s) enrolled in the study will be dilated and slit lamp photography taken using retroillumination.
The capsular tension ring will not be visible in the slit lamp photos or during the eye exams. The patient will be blinded as to which eye is in the treatment or control group. The slit lamp photos will be de-identified and used to determine the axis of the toric IOL by evaluators blinded to the patient identity and control/treatment group. The toric axis will be identified using either ImageJ (NIH) or Adobe Illustrator by measuring the angle between a straight line drawn across the toric axis markers and a straight line at the horizontal axis (0 degrees).
arm group label: Treatment group: toric IOL plus capsular tension ring
arm group type: Experimental
arm group label: Control group: toric IOL only
arm group type: Active Comparator
intervention type: Device
intervention name: MORCHER® EYEJET® CTR Types 14, 14A, and 14C
description: Intervention. Toric IOL + CTR. Whether the subject receives 14, 14A, or 14C is an either or scenario depending on the eye's axial length and is a single intervention:
Axial length > 28.0 mm: CTR model 14A Axial length 24.0-28.0 mm: CTR model 14C Axial length < 24.0 mm: CTR model 14
Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).
arm group label: Treatment group: toric IOL plus capsular tension ring
intervention type: Device
intervention name: Toric IOL Only
description: Control. Toric IOL only. Standard of care cataract surgery without placement of a capsular tension ring.
Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).
arm group label: Control group: toric IOL only
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Rachel A Lieberman, MD
role: Principal Investigator
affiliation: United States Air Force
facility: 
country: United States
citation: Novis C. Astigmatism and toric intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):47-50. doi: 10.1097/00055735-200002000-00007.
PMID: 10724827
citation: Shimizu K, Misawa A, Suzuki Y. Toric intraocular lenses: correcting astigmatism while controlling axis shift. J Cataract Refract Surg. 1994 Sep;20(5):523-6. doi: 10.1016/s0886-3350(13)80232-5.
PMID: 7996408
citation: Holland E, Lane S, Horn JD, Ernest P, Arleo R, Miller KM. The AcrySof Toric intraocular lens in subjects with cataracts and corneal astigmatism: a randomized, subject-masked, parallel-group, 1-year study. Ophthalmology. 2010 Nov;117(11):2104-11. doi: 10.1016/j.ophtha.2010.07.033. Epub 2010 Sep 16.
PMID: 20846724
citation: Felipe A, Artigas JM, Diez-Ajenjo A, Garcia-Domene C, Alcocer P. Residual astigmatism produced by toric intraocular lens rotation. J Cataract Refract Surg. 2011 Oct;37(10):1895-901. doi: 10.1016/j.jcrs.2011.04.036. Epub 2011 Aug 23.
PMID: 21865007
citation: Rastogi A, Khanam S, Goel Y; Kamlesh; Thacker P, Kumar P. Comparative evaluation of rotational stability and visual outcome of toric intraocular lenses with and without a capsular tension ring. Indian J Ophthalmol. 2018 Mar;66(3):411-415. doi: 10.4103/ijo.IJO_875_17.
PMID: 29480253
citation: Shah GD, Praveen MR, Vasavada AR, Vasavada VA, Rampal G, Shastry LR. Rotational stability of a toric intraocular lens: influence of axial length and alignment in the capsular bag. J Cataract Refract Surg. 2012 Jan;38(1):54-9. doi: 10.1016/j.jcrs.2011.08.028. Epub 2011 Nov 4.
PMID: 22055077
citation: Zhao Y, Li J, Yang K, Li X, Zhu S. Combined Special Capsular Tension Ring and Toric IOL Implantation for Management of Astigmatism and High Axial Myopia with Cataracts. Semin Ophthalmol. 2018;33(3):389-394. doi: 10.1080/08820538.2016.1247181. Epub 2016 Dec 22.
PMID: 28005433
citation: Safran SG. Use of Capsular Tension Ring to Prevent Early Post-operative Rotation of a Toric Intraocular Lens in High Axial Myopia. JCRS Online Case reports. 2015.
citation: Sagiv O, Sachs D. Rotation stability of a toric intraocular lens with a second capsular tension ring. J Cataract Refract Surg. 2015 May;41(5):1098-9. doi: 10.1016/j.jcrs.2015.04.004. Epub 2015 Apr 28.
PMID: 25937341
citation: Jung NY, Lim DH, Hwang SS, Hyun J, Chung TY. Comparison of clinical outcomes of toric intraocular lens, Precizon vs Tecnis: a single center randomized controlled trial. BMC Ophthalmol. 2018 Nov 9;18(1):292. doi: 10.1186/s12886-018-0955-3.
PMID: 30413154
responsible party type: Sponsor-Investigator
investigator affiliation: Mike O'Callaghan Military Hospital
investigator full name: Rachel Lieberman
investigator title: Principal Investigator
mesh term: Ophthalmoplegia
mesh term: Cataract
sharing ipd: No
ipd description: We do not plan on sharing data.