<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/NCT04468022</url>
  </required_header>
  <id_info>
    <org_study_id>EyeHospitalPristina</org_study_id>
    <nct_id>NCT04468022</nct_id>
  </id_info>
  <brief_title>Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment</brief_title>
  <official_title>Toric Trifocal IOL Treatment With High Astigmatism and Hyperopia vs SMILE Enhancement After Trifocal IOL Treatment With High Astigmatism and Hyperopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eye Hospital Pristina Kosovo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eye Hospital Pristina Kosovo</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>
      The aim of this study is to assess visual and refractive outcomes after Toric Trifocal lens&#xD;
      implantation and visual outcomes after laser vision correction (LVC) - ReLex Smile to correct&#xD;
      residual refraction after 6 months of Toric Trifocal (IOL) implantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current state of the art for the correction of aphakia and presbyopia after lens&#xD;
      extraction and refractive lensectomy is the implantation of multifocal intraocular lenses&#xD;
      (IOL). In this study, the trifocal IOL types AT LISA TRI 839MP and AT LISA TRI TORIC 939MP&#xD;
      (Carl Zeiss Meditec, Germany) were assessed.&#xD;
&#xD;
      In this prospective non-randomized study patients with spherical hypermetropia of &gt;4 D in&#xD;
      combination with high astigmatism of &gt;3.0 D were treated. The first group of 40 eyes of 20&#xD;
      patients underwent refractive lensectomy, followed by implantation of the diffractive&#xD;
      trifocal IOL type AT LISA TRI 839MP (Carl Zeiss Meditec, Jena, Germany) and 6 months later&#xD;
      SMILE surgery. In 40 eyes of 20 patients in the second group IOL type AT LISA TRI TORIC 939MP&#xD;
      were implanted. All patients were adequately consulted preoperatively about this type of IOLs&#xD;
      and they were verbally consented. The study is adherent to the tenets of the Declaration of&#xD;
      Helsinki. All patient are between 20- 45 years old.&#xD;
&#xD;
      The current study demonstrates that both the non-toric and toric versions of the trifocal IOL&#xD;
      evaluated here provide excellent functional vision to patients, with good distance,&#xD;
      intermediate and near uncorrected VA, a wide range of vision and good contrast sensitivity.&#xD;
&#xD;
      Before SMILE,Yag-Laser capsulotomy should be performed on all patients, regardless of&#xD;
      posterior capsule ossification, in pseudophakic patients with residual refraction. When the&#xD;
      Yag-Laser is applied after the Smile, there will be a diopter change.&#xD;
&#xD;
      Relex Smile surgery in pseudophakic patients with trifocal IOL was safe, effective, and&#xD;
      predictable in a large cohort of patients. It is noteworthy that the decision for a treatment&#xD;
      strategy (toric IOL or non-toric IOL with SMILE in s second step) should be made carefully,&#xD;
      to select the appropriate method for the patient. During phaco surgey the positions of&#xD;
      incisions should be determined according to the angle of the highest K value of the patient.&#xD;
      For high astigmatic patients, toric trifocal IOL is highly effective.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two groups divided in 40 eyes</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of visual and refractive outcome after Toric Trifocal lens implantation</measure>
    <time_frame>6 months</time_frame>
    <description>Complete ocular examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of LVC using ReLex Smile to correct residual refraction after 6 months of Toric Trifocal IOL</measure>
    <time_frame>6 months</time_frame>
    <description>Complete ocular examination</description>
  </secondary_outcome>
  <other_outcome>
    <measure>UDVA, CDVA, CNVA, Goldmann applanation tonometry</measure>
    <time_frame>6 months</time_frame>
    <description>Examinations used</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Astigmatism High Both</condition>
  <condition>Pseudophakia</condition>
  <condition>Hyperopia</condition>
  <arm_group>
    <arm_group_label>Toric Trifocal IOL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twenty patients (20) underwent Toric Trifocal IOL surgery (first group)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Toric Trifocal IOL RELEX SMILE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twenty patients (20) underwent Toric Trifocal IOL and RELEX SMILE surgery (second group)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Toric Trifocal IOL</intervention_name>
    <description>Interventions are performed using a standard technique of sutureless phacoemulsification. In all cases, topical anesthesia was administered and pharmacologic mydriasis was induced using a combination of tropicamide and phenylephrine (10.0%). A mean clear corneal microincision of 2.2 mm was made with a knife according to position of the preop highest K value of the patient. A paracentesis was made 60 degree to 80 degree, clockwise from the main incision, and the anterior chamber was filled with an ophthalmic viscoelastic (OVD) after phacoemulsification/lensectomy and removal of clear lens. The IOL was subsequently implanted through the main incision using the BLUEMIXS 180 injector (Carl Zeiss meditec, Jena, Germany) for trifocal IOL , VISCOJECTTM BIO injector for toric trifocal IOL and then the OVD was removed. Postoperative pharmacologic treatment is performed with the combination of antibiotic and steroidal anti-inflammatory drops</description>
    <arm_group_label>Toric Trifocal IOL</arm_group_label>
    <arm_group_label>Toric Trifocal IOL RELEX SMILE</arm_group_label>
    <other_name>Zeiss Meditec</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. High spherical hypermetropia&#xD;
&#xD;
          2. Astigmatismus &gt;2 D or higher&#xD;
&#xD;
          3. Amblyopia&#xD;
&#xD;
          4. Strabismus (accomodative esotropia)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Glaucoma&#xD;
&#xD;
          2. Retinal detachment&#xD;
&#xD;
          3. Corneal disease&#xD;
&#xD;
          4. Macular degeneration&#xD;
&#xD;
          5. Advanced Retinopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faruk Semiz, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Doctor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eye Hospital Pristina</name>
      <address>
        <city>Pristina</city>
        <zip>10000</zip>
        <country>Kosovo</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kosovo</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>August 29, 2021</last_update_submitted>
  <last_update_submitted_qc>August 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eye Hospital Pristina Kosovo</investigator_affiliation>
    <investigator_full_name>Dr. Faruk Semiz</investigator_full_name>
    <investigator_title>Head of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>RELEX SMILE</keyword>
  <keyword>Trifocal IOL</keyword>
  <keyword>Toric Trifocal IOL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Astigmatism</mesh_term>
    <mesh_term>Hyperopia</mesh_term>
    <mesh_term>Pseudophakia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT04468022/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04468022
org study id: EyeHospitalPristina
nct id: NCT04468022
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess visual and refractive outcomes after Toric Trifocal lens
      implantation and visual outcomes after laser vision correction (LVC) - ReLex Smile to correct
      residual refraction after 6 months of Toric Trifocal (IOL) implantation.
The current state of the art for the correction of aphakia and presbyopia after lens
      extraction and refractive lensectomy is the implantation of multifocal intraocular lenses
      (IOL). In this study, the trifocal IOL types AT LISA TRI 839MP and AT LISA TRI TORIC 939MP
      (Carl Zeiss Meditec, Germany) were assessed.

      In this prospective non-randomized study patients with spherical hypermetropia of >4 D in
      combination with high astigmatism of >3.0 D were treated. The first group of 40 eyes of 20
      patients underwent refractive lensectomy, followed by implantation of the diffractive
      trifocal IOL type AT LISA TRI 839MP (Carl Zeiss Meditec, Jena, Germany) and 6 months later
      SMILE surgery. In 40 eyes of 20 patients in the second group IOL type AT LISA TRI TORIC 939MP
      were implanted. All patients were adequately consulted preoperatively about this type of IOLs
      and they were verbally consented. The study is adherent to the tenets of the Declaration of
      Helsinki. All patient are between 20- 45 years old.

      The current study demonstrates that both the non-toric and toric versions of the trifocal IOL
      evaluated here provide excellent functional vision to patients, with good distance,
      intermediate and near uncorrected VA, a wide range of vision and good contrast sensitivity.

      Before SMILE,Yag-Laser capsulotomy should be performed on all patients, regardless of
      posterior capsule ossification, in pseudophakic patients with residual refraction. When the
      Yag-Laser is applied after the Smile, there will be a diopter change.

      Relex Smile surgery in pseudophakic patients with trifocal IOL was safe, effective, and
      predictable in a large cohort of patients. It is noteworthy that the decision for a treatment
      strategy (toric IOL or non-toric IOL with SMILE in s second step) should be made carefully,
      to select the appropriate method for the patient. During phaco surgey the positions of
      incisions should be determined according to the angle of the highest K value of the patient.
      For high astigmatic patients, toric trifocal IOL is highly effective.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups divided in 40 eyes
primary purpose: Treatment
masking: Single (Participant)
measure: Measure of visual and refractive outcome after Toric Trifocal lens implantation
time frame: 6 months
description: Complete ocular examination
measure: Measure of LVC using ReLex Smile to correct residual refraction after 6 months of Toric Trifocal IOL
time frame: 6 months
description: Complete ocular examination
measure: UDVA, CDVA, CNVA, Goldmann applanation tonometry
time frame: 6 months
description: Examinations used
arm group label: Toric Trifocal IOL
arm group type: Active Comparator
description: Twenty patients (20) underwent Toric Trifocal IOL surgery (first group)
arm group label: Toric Trifocal IOL RELEX SMILE
arm group type: Active Comparator
description: Twenty patients (20) underwent Toric Trifocal IOL and RELEX SMILE surgery (second group)
intervention type: Procedure
intervention name: Toric Trifocal IOL
description: Interventions are performed using a standard technique of sutureless phacoemulsification. In all cases, topical anesthesia was administered and pharmacologic mydriasis was induced using a combination of tropicamide and phenylephrine (10.0%). A mean clear corneal microincision of 2.2 mm was made with a knife according to position of the preop highest K value of the patient. A paracentesis was made 60 degree to 80 degree, clockwise from the main incision, and the anterior chamber was filled with an ophthalmic viscoelastic (OVD) after phacoemulsification/lensectomy and removal of clear lens. The IOL was subsequently implanted through the main incision using the BLUEMIXS 180 injector (Carl Zeiss meditec, Jena, Germany) for trifocal IOL , VISCOJECTTM BIO injector for toric trifocal IOL and then the OVD was removed. Postoperative pharmacologic treatment is performed with the combination of antibiotic and steroidal anti-inflammatory drops
arm group label: Toric Trifocal IOL
arm group label: Toric Trifocal IOL RELEX SMILE
other name: Zeiss Meditec
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Faruk Semiz, Dr.
role: Principal Investigator
affiliation: Principal Doctor
facility: 
country: Kosovo
responsible party type: Principal Investigator
investigator affiliation: Eye Hospital Pristina Kosovo
investigator full name: Dr. Faruk Semiz
investigator title: Head of Ophthalmology
mesh term: Astigmatism
mesh term: Hyperopia
mesh term: Pseudophakia
sharing ipd: No
provided document: 